Opiate-substitution therapy quadruples treatment success in Malaysian heroin users: authors urge adoption in non-western countries

A study from Malaysia published in the June 28th edition of The Lancet has found that substitution therapy with the opiate drug, buprenorphine, tripled the length of time heroin users were able to stay “clean” compared with individuals on a placebo, and nearly quadrupled the proportion of participants who completed the trial without relapse.

An accompanying editorial states that, given these results, “the preferred oral pharmacological treatment for opioid dependence should be agonist maintenance with either methadone or buprenorphine,” and says that concerns that dispensing these drugs could swell black-market use should not outweigh “the major public-health effects of untreated opioid dependence”. Buprenorphine, like methadone, is currently illegal in Malaysia and many other countries with serious injecting drug use problems, such as Russia.

Four times as many individuals given buprenorphine completed the six-month treatment trial without relapse as individuals given naltrexone or placebo; individuals on buprenorphine took on average nearly three times as long to resume heroin use as those on placebo, and twice as long as those on naltrexone. Furthermore individuals provided with buprenorphine were able to stay completely abstinent from heroin for twice as long as those on either naltrexone or placebo.

Substitution therapy using the oral drugs methadone or buprenorphine has been standard practice as a way of trying to wean heroin users off injecting and off street drugs for years in most developed countries. However, in other parts of the world the idea of substituting one opioid for another is still seen as just substituting one addiction for another and adding more drugs into the black market. More recently the opioid antagonist naltrexone – a drug that blocks opioid receptors and so enforces a state of physiological withdrawal from heroin – has been permitted, but although some naltrexone trials report positive results, others have been neutral or negative.

This study was the first ever study in Malaysia to use an opiate agonist – a direct substitute – rather than an antagonist. In the event, the superiority of that agonist, buprenorphine, over both naltrexone and placebo was so marked that the study was terminated before time, when 70% of participants had completed their six month course.

The study involved dependent heroin users. A total of 44 were provided with buprenorphine plus a naltrexone placebo, 43 with naltrexone plus a buprenorphine placebo, and 39 with two placebos. The patients were initially given a fast six-day detox and then provided with substitution therapy or placebo. Urine tests were performed three times weekly to see if they had taken heroin.

Three primary outcome measures were used: time without any heroin use; time to relapse (being defined as three or more consecutive positive heroin tests or a positive test followed by withdrawal from the study); and time remaining on the treatment regime. One other outcome was a global score of HIV risk behaviours, which was split into drug-use and sex-related behaviours.

Patients had a mean age of 37 and were consistent heroin users, with an average of 27 days’ use in the last 30. Only a minority (approximately 41%) were current injectors, though 80% had injected at some point. Twenty-four per cent had shared needles in the last month. Twenty-two per cent were HIV-positive (with fewer in the placebo group, 13%), and the vast majority (95%) had hepatitis C. Only 7% reported consistently using condoms and a third reported having had multiple concurrent sex partners at some point.

At the time the study was terminated, individuals taking the placebo had stayed in treatment for an average of 70 days (out of a maximum possible 168); those on naltrexone for 84 days; and those on buprenorphine for 117 days. Retention was 2.15 times higher amongst buprenorphine users than those taking the placebo and some 1.55 times higher for those randomised to buprenorphine compared to naltrexone; it was 32% higher on naltrexone than placebo, but this was not statistically significant.

Patients on buprenorphine took 2.17 times longer on average to relapse than patients in the placebo arm and 1.56 times longer than patients taking naltrexone. By the end of the study, eleven out of 44 buprenorphine users were still in the study and still abstinent compared with four of those taking naltrexone and three in the placebo arm.

As indicated above, occasional one-off heroin use did not count as ‘relapse’; the mean time subjects manages to remain completely heroin free was 24 days on placebo, 42 days on naltrexone and 59 days on buprenorphine.

Sexual risk behaviours did not change at all during the study; drug-related risk behaviours (i.e. needle sharing) declined throughout the study but did not differ between treatment arms.

The authors report that their results “lend support to dissemination of maintenance treatment with buprenorphine or methadone…as an important component of an effective public-health approach for reduction of problems associated with heroin dependence.”
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References

Schottenfeld R. et al. Maintenance treatment with buprenorphine and naltrexone for heroin dependence in Malaysia: a randomised, double-blind, placebo-controlled trial. The Lancet 371: 2192-2200, 2008.

Hall W. et al. Oral substitution treatments for opioid dependence. The Lancet 371: 2150-2151, 2008.

New Asheville clinic offers safer treatment of opioid addiction

A new clinic is making a safer alternative treatment for opioid addiction more widely available in Western North Carolina.

Crossroads Treatment Center opened in April and specializes in treating people with suboxone, a drug approved by the Food and Drug Administration in 2002.

The biggest advantage of the drug over methadone, which has traditionally been used to treat opioid addiction, may be its safety. A person cannot overdose on suboxone, and because it does not provide the same high as methadone, it is less likely to be abused.

“There are some people who do very well with methadone,” said Dr. Karl Schroeder, a psychiatrist at the VA Medical Center in Asheville. “But because it is a full-on narcotic, if you want to abuse methadone, you can take extra high doses to get blitzed on it. Methadone is one of the more dangerous things for death by overdose. With suboxone, the advantage is in safety. By itself you can’t overdose and kill yourself.”

The increased availability of the drug, a pill that can be prescribed by a doctor, may mean more people in WNC who are addicted to opioids seek treatment. The region is home to a high number of people addicted to the drugs.

Schroeder said he has prescribed suboxone to about two dozen patients at the VA. While it may be too costly for some patients, for others, suboxone helps them break their addiction.

“For many people it’s wonderful,” he said. “They talk about it as being a small miracle in their lives. … They get on suboxone, and they feel normal, and they don’t think about drugs all the time.”

Need for treatment

Dr. Elizabeth Stanton and Vicki Ittel, the former director of the Buncombe County Health Center, opened the new center to offer more treatment options for people addicted to opioids.

“There are just not enough of us,” Stanton said. “I think there’s a huge need in this community.”

WNC is home to many people addicted to prescription painkillers, and the number of people abusing these drugs nationwide increases every year.

Opioids are drugs derived from opium, like morphine, codeine and heroin, and some prescription drugs that have similar chemical properties, including oxycodone, hydrocodone and fentanyl.

“In WNC, we clearly have an increased incidence of narcotic addiction over the general population,” said Dr. Paul Martin, head of the Asheville Buncombe Drug Commission and a specialist in addiction medication.

Martin said he and others who study addiction don’t really know why more people in WNC are addicted to drugs, but what is clear is that there is a need for treatment.

Nick Reuter, a senior public health analyst at the Substance Abuse and Mental Health Administration, said less than half of people who need treatment are getting it.

Treatment for addiction to opioids typically involved methadone. Both methadone clinics in Asheville are operating at capacity and have waiting lists, Martin said.

“We know clearly that the capacity of the methadone programs around the country are not nearly sufficient to meet the need for narcotic addiction,” he said.

Advantages of suboxone

Methadone was the prescribed treatment for opioid addiction until the Food and Drug Administration in 2002 approved two products, suboxone and subutex, which contain buprenorphine, a long-acting opioid.

In 2007, the number of patients being treated for opioid addiction with buprenorphine surpassed the number of patients being treated with methadone, Reuter said.

Methadone patients must visit a clinic daily for treatment, and some stay on methadone for the rest of their lives.

But buprenorphine-containing drugs can be prescribed by a family doctor, are taken in pill form at home and have fewer side effects. Some patients can stop taking the drugs after a few months. This makes these drugs not only more accessible for some people seeking treatment, but also a more appealing choice for some patients.

Reuter said the increased availability of suboxone and subutex has gotten more people into treatment for their addiction. He said 60 percent of patients using the drugs for treatment report never having accessed drug treatment before.

Woodlands Treatment Center in Greenville, S.C., has seen a 92 percent success rate in keeping people off of opioids over its four years of operation, Stanton said.

While some physicians in WNC are licensed to prescribe the drug, not many treat patients in large numbers, Ittel said. The required counseling that goes along with prescribing the drug can be time-consuming and hard to work into a regular medical practice, she said.

For that reason, she said Crossroads is filling a niche market in the region. The clinic is seeing about 50 patients. That number is expected to increase as more people learn about the treatment.

Potential for abuse

Although there have been reports of abuse of buprenorphine, they are fewer than abuse of other drugs in the same class, Reuter said.

Buprenorphine-containing drugs are less appealing to addicts than heroin and methadone because they don’t produce the same kind of euphoria, and when injected at high doses, the drugs can precipitate withdrawal symptoms.

“Two recent studies seem to suggest that (suboxone abuse) has leveled off and started to decrease, but the amount of suboxone dispensed every year continues to increase,” Reuter said.

Methadone still around

While buprenorphine-containing drugs have expanded treatment options, Reuter said there is a need for methadone to stay around. He said methadone is useful for people who are more highly dependent on opioids.

Suboxone also comes at a price. Reuter said suboxone treatment costs around $300 a month, compared with about $30 a month for methadone.

The Crossroads clinic charges around $275 a month, which does not cover the cost of the drug, and they do not take insurance, Stanton said.

The pill, which costs around $5 a day, is covered by insurance and government programs like Medicare and Medicaid.

Ittel said the treatment costs far less than what some people are paying to get their drugs on the street.

“It will be a nice option for a niche population, but as it is prescribed now, it won’t replace methadone programs,” he said.
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source: http://www.citizen-times.com