Naltrexone Implant Costs

(FDA’s Psychopharmacologic Drugs Advisory Committee has now recommended the commercial use of naltrexone for the treatment of opioid dependency).

As you know NALTREXONE is a long-acting opiate blocker. It has been in use since 1992 mainly for treatment of alcoholism and opiate addiction but new uses have been found over time. It is antiopiate and has no effect except for blocking the opiate brain receptors preventing all other opiates from working. Currently, the prescription medication naltrexone is commercially available for the treatment of alcohol dependence under the brand name Vivitrol since it gained approval from the U.S. Food and Drug Administration (FDA) in 2006.

FDA’s Psychopharmacologic Drugs Advisory Committee has now recommended the commercial use of naltrexone for the treatment of opioid dependency. The opioid-blocking, extended-release injectable suspension may become the first non-addictive, non-narcotic drug agent available in a monthly prescription come October.
The Advisory Committee voted 12 to 1 in favor of naltrexone’s use in the treatment of opioid dependency and found the sNDA to be particularly favorable since the clinical trials of the drug showed no apparent serious side effects. The clinical trials did show positive results among sample populations of alcoholics or opioid addicts compared to placebo-administered control groups.

“Efficacy and Safety of Extended-Release Injectable Naltrexone (XR-NTX) for the Treatment of Opioid Dependence,” conducted by lead investigator Dr. Evgeny Krupitsky of St. Petersburg Regional Center of Addictions in Russia found that naltrexone injections successfully reduced drug cravings among opioid-dependent individuals. In a 24-week investigation involving 250 opioid-dependent participants who had opioid addiction for 10 years, the group administered naltrexone injections showed significant reductions in their cravings, physiologic dependence, and self-reported opioid use, and had better retention compared to the placebo group. These participants were more capable of suppressing their cravings, preventing relapse and sustaining abstinence.

Due to the disruption of normal neurotransmission in the brain’s reward system caused by opioid use, opioid abusers become physiologically vulnerable to their cravings and often relapse even after undergoing treatment. The experts from the clinical trials as well as the FDA Advisory Committee caution that naltrexone may not be an absolute cure-all to alcoholism or opiate addiction, but the benefits of this new injectable does give the field of addiction medicine more options when it comes to treating opioid addiction.

New uses for this medication include help for gambling addicts. These addicts are being helped by high dose Nalrexone (100-150 mg per day) as opposed to opiate addicts which can be blocked by only 50 mg per day. This medication is now used for the treatment of sexual addiction and shopping addiction in the dose range of 100-200 mg per day. If you or a loved one has a problem with Vicodin, Heroin, sleep aids, gambling or shopping please call us.

In its editorial, Associate Professor Robert Ali, Director of the Drug Alcohol Services Council in Adelaide, and his co-authors said that naltrexone is theoretically an attractive treatment for opioid dependence because it is inexpensive, long-acting, and generally well tolerated. Oral naltrexone is used as a treatment for heroin and alcohol dependence. However, the effectiveness and safety of oral treatments is compromised by poor patient adherence to taking regular doses. This has led to the development of long-acting naltrexone implants and depot injections.

Naltrexone: can a pill cure alcoholism?

Naltrexone is cheap, effective and requires no costly rehab. So why do so few doctors endorse it?Penny Wark Mrs M, as she asks me to call her, isn’t sure exactly when she last drank herself into a comatose state, but she knows it was about five years ago. At that time she got through a bottle or two each day – and not just wine, she explains. “It was the only way I knew to resolve a problem.”

When I spoke to her last week she had not had a drink for four days, though she expected to have a couple of glasses of wine with a meal on Friday night and the same on Saturday. “Oh yes, I still enjoy good wine. I savour wine. But there’s no craving.”

For anyone who has encountered alcoholism, whether personally or through friends and family, Mrs M’s win-win trouncing of her condition may sound too good to be true. We all know that the only way alcoholics can lead normal lives – as Mrs M does now – is to abstain, and that abstention must be absolute because alcoholics have a distressing habit of resuming their worst excesses after just one drink. Once an alcoholic, always an alcoholic and all that. So how has she done it?

The answer lies in the use of a drug called naltrexone, which Mrs M takes before she drinks. Naltrexone interrupts the pathways in the brain that enable alcohol to release pleasure-giving endorphins. As Matt, another naltrexone user and recovering heavy drinker, puts it: “With naltrexone, it’s weird. You drink and you feel the effect of the alcohol but it doesn’t have the magic.”

Related Links
Am I an alcoholic?
Home detoxing my alcoholic friend
If, each time you engage in a behaviour that releases endorphins, you strengthen that behaviour, it follows that if you engage in the behaviour and don’t get the endorphin release, you weaken the urge to use it. Thus, unburdened by a craving for alcohol, a former heavy drinker can use alcohol with control.

That is the theory and this treatment for alcoholism is called the Sinclair Method, after David Sinclair, the scientist who discovered it and who claims a 78 per cent success rate over three to four months. The measure of success is controlled drinking within normal safety limits, or abstinence.

In Finland, where Sinclair works at the National Public Health Institute, his method has become part of the mainstream treatment for alcoholism, used by 100,000 people since 1995, he estimates. In the US it is used by 2 per cent of doctors who treat alcoholism. In the UK, however, naltrexone is licensed for the treatment of heroin addiction but not alcoholism (though it is available on private prescription) and Mrs M, who lives in Scotland, is fortunate to have an enlightened doctor who has sought permission to use it to treat alcohol problems for about 50 carefully selected patients over the past ten years.

Two months ago a book championing the Sinclair Method was published in the US. Called The Cure for Alcoholism, it has sold a few thousand copies but received no media coverage. In it the author, Roy Eskapa, a psychologist who has worked with Sinclair since the 1990s, hails him as a genius who deserves a Nobel prize for finding a cure for the world’s biggest killing disease. According to the World Health Organisation, alcohol addiction kills 1.8 million people a year, and in the UK the British Medical Association estimates that one adult in 25 is alcohol-dependent. Sinclair’s work could change the way in which society perceives addiction, making it a treatable condition rather than incurable, Eskapa maintains.

His claims are big – preposterous, some would say. But perhaps the most remarkable aspect of this story, which began some 40 years ago, is that while Sinclair can name 76 clinical trials that prove the efficacy and safety of his method, most alcohol addiction professionals don’t know about it, or reject it. “I cannot help remarking that anyone who claims to have found a ‘cure for alcoholism’ cannot be taken seriously,” says one of the UK Government’s eminent advisers on alcoholism.

To understand why the Sinclair Method is often ignored, we need first to look at how Sinclair made his discovery. In 1964, as an undergraduate at the University of Cincinnati, he was involved in research on alcohol and rats. Given rats that had been denied alcohol for two weeks, he decided to test a theory and gave them a choice of an alcohol solution or water. Even though it was daytime, a rat woke up and “started drinking the alcohol solution almost out of my hands”, says Sinclair. The other rats joined in. After more studies, Sinclair began to see that the more the rats were deprived of alcohol, the more they craved it.

“Nobody had seen motivation for alcohol in a rat before,” he says. “This changed the understanding of what causes alcoholic drinking. At that time almost everybody in the field accepted that there wasn’t enough pleasure from drinking alcohol to make an alcoholic drink. The pleasure didn’t match the unpleasantness, so they theorised that the craving was caused by withdrawal symptoms, by physiological dependence, and all alcoholics were drinking to avoid withdrawal. So the main treatment was to get rid of the physiological dependence – you sent them to rehab with the idea that they would come out and have no reason to drink. If dependence was the cause, it should have been a cure, but it isn’t.

“So we starting rethinking what causes alcoholism. It is learnt. A person isn’t born an alcoholic but every time they drink there is a release of endorphins. For genetic reasons some people have very powerful receptors for endorphins, get a lot of reinforcement from the alcohol and have a high risk of developing alcoholism. The neural structure that is causing this behaviour, and the craving, gets stronger each time they drink, and with some people it becomes so strong that they can’t control it. The only solution is somehow to weaken the behaviour that is so powerful.”

Sinclair moved to Finland in 1972 and, after many more studies, he decided that the best drug to extinguish alcoholic craving was naltrexone. It is not addictive, it has been proved to be safe in 50mg doses, it does not require detoxification because it reduces craving slowly, and it is cheap – about £170 for three months’ supply.

Balancing the numerous trials that prove that it leads to controlled drinking, loss of craving and sometimes voluntary abstinence for alcoholics and heavy drinkers, there are also 36 trials that indicate that naltrexone does not work if you are abstinent when you start using it. The Sinclair Method is specific: naltrexone plus alcohol equals cure. For it to work, you have to continue to drink. You take naltrexone only on the days you drink and, as your craving for alcohol reduces, you will drink less. If eventually you choose not to drink, you will not take naltrexone.

The need to continue to drink initially is the main reason why the Sinclair Method has been rejected by so many alcohol addiction professionals. Most are wedded to the idea promulgated by Alcoholics Anonymous’s 12-step programme that treatment must involve abstinence. Naltrexone was endorsed for use in alcoholism by the World Health Organisation in 1994 and by the US Food and Drug Administration in 1995. In 2006 the American Medical Association recommended it for treating alcoholism in generalised medical settings. Yet many doctors appear to be uncomfortable advising patients that they must take a drug and also drink – so, when they prescribe it, they insist on abstinence.

Two of the US users of naltrexone to whom I spoke had been unable to get it on prescription. One lied to a psychiatrist, saying that he was abstinent and wanted to use the drug to help with cravings (it doesn’t work when used in this way), the other bought it without prescription on the internet. Both reported a steady decline in their craving for alcohol after two months.

Sinclair and Eskapa also believe that the commercial interests of the drug industry – naltrexone is a generic drug – and the £4 billion-a-year rehabilitation business make the Sinclair Method an unpoular choice: there is little money to be made from giving an outpatient a prescription for naltrexone. As one doctor said to Sinclair when he gave a presentation about it at a detox clinic in Virginia: “Yes, but how do we make a living?”

Could the Sinclair Method kill off the alcohol rehab industry? I ask Sinclair. “It could,” he replies, “though some people will still need detox if their liver is too shot to take naltrexone.” Calls to the Priory Group in the UK elicited only the response that doctors there don’t know enough about the Sinclair Method to comment. Which raises the question: why not? At Winthrop Hall in Kent, David Bremner, the medical director, said that he uses a combination of cognitive behavioural therapy, family therapy and the 12-step programme “because we use what works” and because the outcomes for controlled drinking compare poorly with abstinence, which he recommends.

Sinclair would dispute that: one clinical trial shows a 50 per cent success rate for the Sinclair Method after three years; three-year figures for the 12-step programme are more commonly about 5 per cent. “We would certainly use the Sinclair Method if it was going to enhance a client’s chance of recovery,” says Bremner. “Where Sinclair is to be commended is that he’s not trying to make money out of it.”

In Edinburgh Dr Jonathan Chick, consultant psychiatrist at the NHS Lothian Alcohol Problems Service, continues to see Mrs M every six weeks. He prefers to use naltrexone in conjunction with counselling, in spite of clinical trials that suggest that this is unecessary.

“Naltrexone does indeed reduce some of the brain-stimulation effects of alcohol,” says Chick. “I don’t think it’s right to claim that this is a universal solution for all people who have problems with excessive drinking but it does help some. We prescribe it to people who continue to drink in the hope that it will reduce the frequency of the sessions where they drink to excess and put themselves at risk. If they take naltrexone before they drink, they can have some satisfaction from the taste and some mental effect from the alcohol but report that they don’t want to carry on and ‘lose control’ of the amount they drink. Unfortunately, quite a lot of our patients don’t take it as prescribed.”

Chick agrees that naltrexone may not serve the commercial interests of the pharmaceutical industry. “The other reason the Sinclair Method hasn’t been taken up is a very correct reservation about sanctioning continued drinking by people with severe alcohol problems. For many, complete abstinence is by far the best method and needs to be applied quickly. Those who espouse that can do very well. If I was asked by a patient who had been abstinent for a year if I would give him naltrexone so he could resume drinking, I would advise against it.”

Mrs M, who is 55, doesn’t see naltrexone as a cure-all either, and can’t imagine taking it without the support of her family and Dr Chick. “It’s helped to stop me picking arguments, I’ve got my personality back and my marriage wouldn’t have survived without it,” she says. “You can use it as you wish, as long as someone explains everything fully. It’s not a magic wand but I can’t understand why it’s not widely available. It needs to be widely discussed.”

The Cure for Alcoholism by Roy Eskapa, BenBella Books, $14.95; available

in the UK for £9.99 plus p&p from naturalcollection.com

Transcript
11/8/1999
The pros and cons of Naltrexone

KERRY O’BRIEN: Up to 180,000 Australians are addicted to heroin — epidemic proportions — and heroin use is still on the rise. In the search for a cure, Federal and State Governments have been keen to embrace the so called “wonder drug” Naltrexone, at least on a trial basis, in the hope it will break many addicts’ dependency on heroin.

Today, the results of the biggest publicly funded trial of Naltrexone were released. And while the 60 per cent success rate may seem impressive, some drug authorities are still urging caution. Philippa McDonald reports.

DR JON CURRIE, WESTMEAD HOSPITAL: I don’t think the scientific community is necessarily sniping, but certainly they do seem to have a relatively entrenched position against Naltrexone.

DR ALEX WODAK, ST VINCENTS HOSPITAL: We mustn’t make the mistake of trying to pretend that it’s be tter than it really is.

PHILIPPA McDONALD: While the effectiveness of Naltrexone as a treatment for heroin addict ion has sparked fierce scientific debate it’s more than just an academic argument for Max and Bev, whose daughter was desperate to get off heroin.

MAX HAWKINS: She just wanted to be free of this drug thing. She was just so pleased to be in the hospital and — “Dad tomorrow new life, I’m out of this”.

That’s the way she’d talk, you know.

“I’m out of here dad”.

PHILIPPA McDONALD: And you thought you’d get your daughter back?

MAX HAWKINS: Yes.

I thought so.

PHILIPPA McDONALD: Larissa Hawkins has been using heroin for well over a decade and while she’d tried a host of drug treatments, she could never shake her addiction.

But when she heard of Naltrexone, 31-year-old Larissa thought there may just be light at the end of the tunnel.

BEVERLY LYNEL: The last thing I actually said to Larissa was, I gave her a kiss and a cuddle and I said to her “You don’t have to do this you know if you don’t want to do it”.

She had tears in her eyes. And that was my last words to Lara, was “You don’t really have to go through this”.

PHILIPPA McDONALD: Larissa paid the now defunct CITA Institute $9,700 to undergo rapid detox treatment at the Brisbane Waters Private Hospital. Barely a day later, she was dead. This country country’s first Naltrexone-related death while under hospital care.

MAX HAWKINS: I was on just one knee outside, because I knew she’d gone as soon as I went out there. I just knew she wasn’t coming back. I just got on one knee and just cried me bloody heart out.

DR JON CURRIE AT CONFERENCE: Our outcomes at six months are relatively clear. 60 per cent of people approximately at six months are not opiate dependent.

PHILIPPA McDONALD: Today, the findings of Australia’s largest publicly funded Naltrexone trial were released to a hungr y media and a growing number looking for a way of ending a national heroin epidemic.

DR JON CURRIE: Naltrexone works by blocking the receptors in the brain that heroin and methadone act on. So if you take Naltrexone, heroin can’t affect the brain, you basically don’t crave and you can’t get re-addicted while you take the Naltrexone.

PHILIPPA McDONALD: Doctor Currie points to success stories like Julia Northcott, a heroin addict for the past 15 years.

JULIA NORTHCOTT: And in the end, I just lost everything.

I hit rock bottom and I got to the point where I said to myself that if I hadn’t got off by 40, I was going to kill myself. It got that bad.

I’ve probably got the most expensive arms in history, I went through about $50,000 in six months, I’ve overdosed in public toilets, I’ve overdosed in other people’s homes.

I’ve overdosed while driving a car and had a car accident.

PHILIPPA MCDONALD: With your daughter in the car?

JULIA NORTHCOTT: With my daughter in the car, yes.

PHILIPPA McDONALD: Julia has been a heroin addict for most of Tanya’s life.

TANYA NORTHCOTT: Like, I knew she loved me and that, but I just knew that — I felt that drugs was like, heroin was first kind of thing.

PHILIPPA McDONALD: Now her mother has been off heroin for four and a half months.

JULIA NORTHCOTT: Absolutely wonderful. I am so proud of myself. I’m proud that I’m on Naltrexone and I’ll admit that I’m proud of it. If it wasn’t for Dr Currie and Westmead Hospital, I don’t know where I’d be now.

PHILIPPA McDONALD: Despite the accolades from his patients, Doctor Currie has some prominent critics.

DR RICHARD MATTICK, NATIONAL DRUG & ALCOHOL RESEARCH CENTRE: I think the results are extraord inary.

I think that they’re very unusual, they are not replicated anywhere else in the world, there are no trials which get the rates of absence that he has reported.

DR ALEX WODAK: The trials were not subjected to the usual peer review process and the ordinary member of the public might think this is just one doctor getting cranky about some other treatment he doesn’t care for, but the due scientific process is just as important as the due legal process, in terms of getting good outcomes.

DR JON CURRIE: The aim is, of course, to present this to a scientific journal and have it peer-reviewed when the study reaches 12 months.

PHILIPPA McDONALD: To what extent Dr Currie are you doing what doctors don’t usually do and that is, you’re releasing your findings without publishing them in a scientific journal before han d?

DR JON CURRIE: We haven’t rushed into press with results that are in fact spurious, or results which are preliminary.

PHILIPPA McDONALD: But you’ve rushed to the press?

DR JON CURRIE: No, we haven’t rushed to the press, you’ve rushed to us.

PHILIPPA McDONALD: It’s early days yet, but Doctor Currie’s success stories like Julia, are confident they can stay off the drug which has held them captive for up to half their l ives.

JULIA NORTHCOTT: I just know in my heart I won’t use. I just know that I will not ever use that drug again. My life’s too wonderful.

PHILIPPA McDONALD: While 170 patients took part in Dr Currie’s public hospital trial, thousands more addicts are undertaking Naltrexone treatment at private clinics, which remain unregulated.

MERRILYN WALTON, HEALTH CARE COMPLAINTS COMMISSION: I think we need extreme caution and we need to abide by clinical, ethical guidelines, rather than operating like a business.

The Health Care Complaints Commission is investigating a series of complaints against private Naltrexone clinics and is prepared to look at the case of Larissa Hawkins’ death if it receives a complaint.

MERRILYN WALTON: One would want to know what information she was given prior to the treatm ent, what information she was given in relation to the risk and side effects.

PHILIPPA MCDONALD: The coronial inquest into Larissa’s death starts in a couple of weeks. Her treatment provider, CITA, recently went into liquidation and declined to comment ahead o f the coroner’s findings. But for now, Larissa’s parents are grappling to understand why such optimism ended in tragedy.

BEVERLY LYNEL: And I just want people to really be careful before they make their decisions. To make sure everything’s exactly right, you know, before they go in, before they take the treatment.

So, I don’t want this to happen to another family, that’s it, without you know. It’s just devastating.

Naltrexone: can a pill cure alcoholism?
Naltrexone is cheap, effective and requires no costly rehab. So why do so few doctors endorse it?
Penny Wark
Mrs M, as she asks me to call her, isn’t sure exactly when she last drank herself into a comatose state, but she knows it was about five years ago. At that time she got through a bottle or two each day – and not just wine, she explains. “It was the only way I knew to resolve a problem.”
When I spoke to her last week she had not had a drink for four days, though she expected to have a couple of glasses of wine with a meal on Friday night and the same on Saturday. “Oh yes, I still enjoy good wine. I savour wine. But there’s no craving.”
For anyone who has encountered alcoholism, whether personally or through friends and family, Mrs M’s win-win trouncing of her condition may sound too good to be true. We all know that the only way alcoholics can lead normal lives – as Mrs M does now – is to abstain, and that abstention must be absolute because alcoholics have a distressing habit of resuming their worst excesses after just one drink. Once an alcoholic, always an alcoholic and all that. So how has she done it?
The answer lies in the use of a drug called naltrexone, which Mrs M takes before she drinks. Naltrexone interrupts the pathways in the brain that enable alcohol to release pleasure-giving endorphins. As Matt, another naltrexone user and recovering heavy drinker, puts it: “With naltrexone, it’s weird. You drink and you feel the effect of the alcohol but it doesn’t have the magic.”
If, each time you engage in a behaviour that releases endorphins, you strengthen that behaviour, it follows that if you engage in the behaviour and don’t get the endorphin release, you weaken the urge to use it. Thus, unburdened by a craving for alcohol, a former heavy drinker can use alcohol with control.
That is the theory and this treatment for alcoholism is called the Sinclair Method, after David Sinclair, the scientist who discovered it and who claims a 78 per cent success rate over three to four months. The measure of success is controlled drinking within normal safety limits, or abstinence.
In Finland, where Sinclair works at the National Public Health Institute, his method has become part of the mainstream treatment for alcoholism, used by 100,000 people since 1995, he estimates. In the US it is used by 2 per cent of doctors who treat alcoholism. In the UK, however, naltrexone is licensed for the treatment of heroin addiction but not alcoholism (though it is available on private prescription) and Mrs M, who lives in Scotland, is fortunate to have an enlightened doctor who has sought permission to use it to treat alcohol problems for about 50 carefully selected patients over the past ten years.
Two months ago a book championing the Sinclair Method was published in the US. Called The Cure for Alcoholism, it has sold a few thousand copies but received no media coverage. In it the author, Roy Eskapa, a psychologist who has worked with Sinclair since the 1990s, hails him as a genius who deserves a Nobel prize for finding a cure for the world’s biggest killing disease. According to the World Health Organisation, alcohol addiction kills 1.8 million people a year, and in the UK the British Medical Association estimates that one adult in 25 is alcohol-dependent. Sinclair’s work could change the way in which society perceives addiction, making it a treatable condition rather than incurable, Eskapa maintains.
His claims are big – preposterous, some would say. But perhaps the most remarkable aspect of this story, which began some 40 years ago, is that while Sinclair can name 76 clinical trials that prove the efficacy and safety of his method, most alcohol addiction professionals don’t know about it, or reject it. “I cannot help remarking that anyone who claims to have found a ‘cure for alcoholism’ cannot be taken seriously,” says one of the UK Government’s eminent advisers on alcoholism.
To understand why the Sinclair Method is often ignored, we need first to look at how Sinclair made his discovery. In 1964, as an undergraduate at the University of Cincinnati, he was involved in research on alcohol and rats. Given rats that had been denied alcohol for two weeks, he decided to test a theory and gave them a choice of an alcohol solution or water. Even though it was daytime, a rat woke up and “started drinking the alcohol solution almost out of my hands”, says Sinclair. The other rats joined in. After more studies, Sinclair began to see that the more the rats were deprived of alcohol, the more they craved it.
“Nobody had seen motivation for alcohol in a rat before,” he says. “This changed the understanding of what causes alcoholic drinking. At that time almost everybody in the field accepted that there wasn’t enough pleasure from drinking alcohol to make an alcoholic drink. The pleasure didn’t match the unpleasantness, so they theorised that the craving was caused by withdrawal symptoms, by physiological dependence, and all alcoholics were drinking to avoid withdrawal. So the main treatment was to get rid of the physiological dependence – you sent them to rehab with the idea that they would come out and have no reason to drink. If dependence was the cause, it should have been a cure, but it isn’t.
“So we starting rethinking what causes alcoholism. It is learnt. A person isn’t born an alcoholic but every time they drink there is a release of endorphins. For genetic reasons some people have very powerful receptors for endorphins, get a lot of reinforcement from the alcohol and have a high risk of developing alcoholism. The neural structure that is causing this behaviour, and the craving, gets stronger each time they drink, and with some people it becomes so strong that they can’t control it. The only solution is somehow to weaken the behaviour that is so powerful.”
Sinclair moved to Finland in 1972 and, after many more studies, he decided that the best drug to extinguish alcoholic craving was naltrexone. It is not addictive, it has been proved to be safe in 50mg doses, it does not require detoxification because it reduces craving slowly, and it is cheap – about £170 for three months’ supply.
Balancing the numerous trials that prove that it leads to controlled drinking, loss of craving and sometimes voluntary abstinence for alcoholics and heavy drinkers, there are also 36 trials that indicate that naltrexone does not work if you are abstinent when you start using it. The Sinclair Method is specific: naltrexone plus alcohol equals cure. For it to work, you have to continue to drink. You take naltrexone only on the days you drink and, as your craving for alcohol reduces, you will drink less. If eventually you choose not to drink, you will not take naltrexone.
The need to continue to drink initially is the main reason why the Sinclair Method has been rejected by so many alcohol addiction professionals. Most are wedded to the idea promulgated by Alcoholics Anonymous’s 12-step programme that treatment must involve abstinence. Naltrexone was endorsed for use in alcoholism by the World Health Organisation in 1994 and by the US Food and Drug Administration in 1995. In 2006 the American Medical Association recommended it for treating alcoholism in generalised medical settings. Yet many doctors appear to be uncomfortable advising patients that they must take a drug and also drink – so, when they prescribe it, they insist on abstinence.
Two of the US users of naltrexone to whom I spoke had been unable to get it on prescription. One lied to a psychiatrist, saying that he was abstinent and wanted to use the drug to help with cravings (it doesn’t work when used in this way), the other bought it without prescription on the internet. Both reported a steady decline in their craving for alcohol after two months.
Sinclair and Eskapa also believe that the commercial interests of the drug industry – naltrexone is a generic drug – and the £4 billion-a-year rehabilitation business make the Sinclair Method an unpoular choice: there is little money to be made from giving an outpatient a prescription for naltrexone. As one doctor said to Sinclair when he gave a presentation about it at a detox clinic in Virginia: “Yes, but how do we make a living?”
Could the Sinclair Method kill off the alcohol rehab industry? I ask Sinclair. “It could,” he replies, “though some people will still need detox if their liver is too shot to take naltrexone.” Calls to the Priory Group in the UK elicited only the response that doctors there don’t know enough about the Sinclair Method to comment. Which raises the question: why not? At Winthrop Hall in Kent, David Bremner, the medical director, said that he uses a combination of cognitive behavioural therapy, family therapy and the 12-step programme “because we use what works” and because the outcomes for controlled drinking compare poorly with abstinence, which he recommends.
Sinclair would dispute that: one clinical trial shows a 50 per cent success rate for the Sinclair Method after three years; three-year figures for the 12-step programme are more commonly about 5 per cent. “We would certainly use the Sinclair Method if it was going to enhance a client’s chance of recovery,” says Bremner. “Where Sinclair is to be commended is that he’s not trying to make money out of it.”
In Edinburgh Dr Jonathan Chick, consultant psychiatrist at the NHS Lothian Alcohol Problems Service, continues to see Mrs M every six weeks. He prefers to use naltrexone in conjunction with counselling, in spite of clinical trials that suggest that this is unecessary.
“Naltrexone does indeed reduce some of the brain-stimulation effects of alcohol,” says Chick. “I don’t think it’s right to claim that this is a universal solution for all people who have problems with excessive drinking but it does help some. We prescribe it to people who continue to drink in the hope that it will reduce the frequency of the sessions where they drink to excess and put themselves at risk. If they take naltrexone before they drink, they can have some satisfaction from the taste and some mental effect from the alcohol but report that they don’t want to carry on and ‘lose control’ of the amount they drink. Unfortunately, quite a lot of our patients don’t take it as prescribed.”
Chick agrees that naltrexone may not serve the commercial interests of the pharmaceutical industry. “The other reason the Sinclair Method hasn’t been taken up is a very correct reservation about sanctioning continued drinking by people with severe alcohol problems. For many, complete abstinence is by far the best method and needs to be applied quickly. Those who espouse that can do very well. If I was asked by a patient who had been abstinent for a year if I would give him naltrexone so he could resume drinking, I would advise against it.”
Mrs M, who is 55, doesn’t see naltrexone as a cure-all either, and can’t imagine taking it without the support of her family and Dr Chick. “It’s helped to stop me picking arguments, I’ve got my personality back and my marriage wouldn’t have survived without it,” she says. “You can use it as you wish, as long as someone explains everything fully. It’s not a magic wand but I can’t understand why it’s not widely available. It needs to be widely discussed.”

Fresh Start Private Naltrexone Implant Procedure Shows Excellent Potential for Reduction in Alcoholism
11 December 2010

Fresh Start Private, a leader in the alcohol treatment and rehabilitation industry, provided data today showing that Naltrexone is effective in the treatment of alcoholism.

According to published results in the Oxford Journals, research indicated that “Naltrexone is superior to placebo. Subjects treated with Naltrexone experience significantly fewer episodes of relapse, and significantly more remain abstinent when compared to placebo-treated subjects {risk difference of relapse rates = -14% [95% confidence interval (CI): -23%, -5%]; and risk difference of abstinence rates = 10% (95% CI: 4%, 16%)} after 12 weeks of treatment. The Naltrexone-treated subjects also consume significantly less alcohol over the study period than do placebo-treated subjects.” See http://alcalc.oxfordjournals.org/content/36/6/544.full for the complete results of the study.

A study by Joseph R. Volpicelli, MD, PhD; Arthur I. Alterman, PhD; Motoi Hayashida, MD, ScD; Charles P. O’Brien, MD, PhD, yielded other significant findings as follows:

“Seventy male alcohol-dependent patients participated in a 12-week, double-blind, placebo-controlled trial of Naltrexone hydrochloride (50 mg/d) as an adjunct to treatment following alcohol detoxification. Subjects taking Naltrexone reported significantly less alcohol craving and days in which any alcohol was consumed. During the 12-week study, only 23% of the Naltrexone-treated subjects met the criteria for a relapse, whereas 54.3% of the placebo-treated subjects relapsed. The primary effect of Naltrexone was seen in patients who drank any alcohol while attending outpatient treatment. Nineteen (95%) of the 20 placebo-treated patients relapsed after they sampled alcohol, while only eight (50%) of 16 Naltrexone-treated patients exposed to alcohol met relapse criteria. These results suggest that Naltrexone may be a safe and effective adjunct to treatment in alcohol-dependent subjects, particularly in preventing alcohol relapse.”

Fresh Start Private (FSP) is the only alcohol treatment program to offer a single-administration, licensed long-acting, Naltrexone implant procedure. Naltrexone has been approved for use by the FDA within the United States for the treatment of alcohol.

Trained medical doctors insert a specially formulated, biodegradable Naltrexone implant just beneath the skin below the patient’s lower abdominal area. The procedure is rapid and requires only local anaesthetic.

FSPs revolutionary procedure works instantly to block the receptors in the brain that crave alcohol. This one-time treatment is affordable and so fast a patient can be back to work the very next day, free from the physical cravings for alcohol.

Fresh Start Private