NEW YORK ― Patients severely addicted to heroin may respond to a treatment practice that incorporates pharmaceutical heroin, a new feasibility study suggests.
An open-label, randomized controlled trial (RCT) of 74 patients showed that significantly more of those who received diacetylmorphine under strict nurse supervision in a specialized center responded at 3, 6, and 9 months after starting treatment than those who received methadone.
"There have been similar studies elsewhere, and we wanted to see if this was useable in Belgium," lead author Marc Ansseau, MD, PhD, professor at the University of Liège in Belgium, told Medscape Medical News.
"We wanted to see if these patients could adapt to this treatment ― and the results were excellent," added Dr. Ansseau.
The findings were presented here at the American Psychiatric Association's (APA's) 2014 Annual Meeting.
Decreased Street Use
"In Switzerland, a new treatment with prescribed diacetylmorphine (pharmaceutical heroin) was developed to help…heroin addicts resistant to methadone treatment to decrease their street heroin use," explain the researchers.
This heroin-assisted treatment (HAT) is administered up to 3 times daily in a controlled environment.
So far, 6 RCTs have been conducted in Switzerland, the Netherlands, Spain, Germany, Canada, and the United Kingdom showing superior efficacy of HAT vs methadone.
"Patients used less street heroin, their health improved, and their criminal behavior decreased," report the investigators.
For the current study, they sought to examine the feasibility of HAT and, specifically, treatment assisted by diacetylmorphine (TADAM), in Belgium.
A total of 74 adults were enrolled, all of whom had been addicted to heroin for at least 5 years, used street heroin almost daily, and had tried recovery through methadone treatment at least once previously.
"Many of these actually had been addicted for 10, 20 years ― a very long duration of dependency," said Dr. Ansseau.
The participants were randomly assigned to receive their choice of inhaled or injected diacetylmorphine at a mean daily dose of 574 mg in a new HAT center in Belgium (N = 36) or methadone at a daily dose of 77 mg (n = 38) for 12 months.
At the endpoint, TADAM was stopped and "the best available treatment was offered to the patient." However, those who were randomly assigned to receive methadone could continue.
At baseline and every 3 months during treatment, the patients were assessed using the European Addiction Severity Index, the Maudsley Addiction Profile–Health Symptom Scale, and the Symptom Checklist-90-Revised (SCL-90-R) questionnaire. They were also asked about any criminal involvement. Toxicology and criminal reports were also examined.
The primary efficacy measure was treatment response.
Results showed that significantly more of the TADAM group responded to treatment compared with the methadone group at the 3-month (P < .05), 6-month (P < .05), and 9-month points (P < .01). In fact, there were at least 30% more responders in the TADAM group at each of these evaluation times.
Although there were 11% more responders in the TADAM group at the 12-month point, this was no longer considered significant. In addition, the condition of the TADAM group members was worse at the 12-month assessment vs their 9-month assessment.
Dr. Ansseau noted that this could be explained in part because the patients knew that the treatment was going to end at 12 months, and the expectation of that may have caused them to start to backslide. He added that this treatment should not have a specific and stated endpoint.
"I think treatment should continue as much as necessary," he said.
"Setting an arbitrary time limit for HAT is also in contradiction with the long-term character of this chronic relapsing disease," add the investigators.
Other results showed that "street heroin used in the past 30 days" decreased significantly more for the TADAM group throughout the study period vs the methadone group (P = .001).
Also, mental health scores on the SCL-90-R, "particularly on the depression and psychocriticism dimensions," improved significantly (P = .002 for both dimensions).
Overall, "as in other countries, HAT is an effective treatment for severe heroin addicts resistant to methadone treatments," write the investigators.
Dr. Ansseau reported that the researchers are now "trying to convince the government of Belgium" to implement this type of treatment without duration limits.
When asked whether he would recommend that other countries, including the United States, investigate the use of TADAM, he answered, "totally" ― especially in such a hard-to-treat patient population.
"This is a treatment for very strongly addicted patients. It's not for first treatment."
"This was interesting, but the study left me with a lot of questions, such as, how aggressive was the past methadone treatment for these patients?" Frances Levin, MD, professor of psychiatry at Columbia University Medical Center (CUMC) in New York City, told Medscape Medical News.
I think this [TADAM] is an end-stage approach. I think you'd have to be where nothing else works before you'd consider using heroin 3 times a day. There's no drug that's good or bad; the issue is more with the delivery system."
Dr. Levin, who was not involved with this research, is also chair of the APA's Council on Addictions and is past president of the American Academy of Addiction Psychiatry.
She noted that the time involvement needed with this type of treatment would greatly affect a patient's "ability to be out in the world and functioning."
"The concern for me with this study is the way this drug would have to be delivered and what that would do in terms of causing their lives to be more circumscribed than a methadone program, where you could take a dose and leave for the day," said Dr. Levin.
Still, "I never say never about anything that might be helpful. And on certain measures, this was found to be helpful. So in a narrow niche of candidates, after you've tried a lot of other approaches, this might not be totally unreasonable to consider."
However, she added that she thought it would be a difficult treatment to get accepted in the United States.
Maria Sullivan, MD, PhD, associate professor of psychiatry at CUMC, agreed, adding that there are better treatment alternatives readily available in the United States.
"I would think for a patient who has failed a first attempt at agonist maintenance with methadone, try either a second partial agonist like buprenorphine, which is very well received, or antagonist treatment with injectable Vivitrol [injectable naltrexone]," said Dr. Sullivan, who is also the clinical expert for the Providers' Clinical Support System for Medication Assisted Treatment.
"There is a lot of data to support the efficacy of both buprenorphine and naltrexone in preventing relapse," she said. "It's not clear to me that [TADAM] represents any advantage over existing treatments. Instead, I'd look at it only as a court of last resort."
Both women added that "adequate social support" is also needed for these patients.
"Even methadone won't work well if all you're giving people is just a minimal dose of it. Other interventions on top of it are critical," said Dr. Levin.
The study authors report no relevant financial relationships. Dr. Sullivan reported that Alkemes provided medication for a National Institute on Drug Abuse–funded study in which she is participating. Dr. Levin reported receiving medication from US World Meds for a cannabis use study and has been a consultant for GW Pharmaceuticals but which does not in any way involve opioids.
American Psychiatric Association's 2014 Annual Meeting. Abstract NR3-006. Poster presented May 4, 2014.
May 13, 2014
Medscape Medical News
Heroin-Assisted Tx Superior to Methadone for Heroin Addiction