25 May Study Examines Treatment for Prescription Opioid Dependence
At the American Psychiatric Association 2010 Annual Meeting, a study was presented that found that people addicted to prescription opioids (such as Vicodin and OxyContin) are more prone to relapse after a shorter treatment course. The study, the largest treatment study ever conducted for prescription opioid dependence, specifically examined whether adding intense counseling to taking buprenorphine improves outcome, what the best duration of medication is best, and whether current chronic pain influences outcomes.
Medscape Today reports that The National Drug Abuse Treatment Clinical Trials Network Prescription Opioid Addiction Treatment Study found that those who tapered off the medication using buprenorphine during a 9-month period, whether initially or after a period of improvement, almost universally relapsed.
Roger D. Weiss, MD, professor of psychiatry at Harvard Medical School in Boston, and chief of the Division of Alcohol and Drug Abuse, McLean Hospital in Belmont, Massachusetts, said: "There has been virtually no research on the treatment of persons dependent on prescription opioids, in spite of the major increase in prescription opioid abuse and in the numbers of persons entering treatment for addiction to prescription opioids.”
"The trial was designed to help the physician manage patients who are dependent on opioids and want off the drugs but refuse treatment in a drug abuse treatment program," Dr. Weiss said.
The study enrolled 653 people with prescription opioid dependency and offered them standard medical management, which included buprenorphine, an initial one-hour visit, and weekly 20-minute sessions with a physician who counseled the patients and monitored for adverse drug effects. Half the group remained in this standard medical management group and half received enhanced medical management, which included twice-weekly 60-minute individualized drug counseling focusing on interpersonal issues, coping with triggers and high-risk situations, homework, and more.
Patients were evaluated after periods of individualized buprenorphine tapering and maintenance and were assessed for abstinence from opioids at various times.
Several patients reported current chronic pain (42%), and some were taking opioids for this condition. Many patients reported a lifetime history of heroin use (23%), alcohol abuse (60%) or dependence (27%), cannabis abuse (47%) or dependence (15%), and cocaine abuse (32%) or dependence (18%).
Opioids used within 30 days included sustained-release oxycodone (35%), hydrocodone (32%), immediate-release oxycodone (19%), methadone (6%), and others (8%).
Thirty percent of subjects had received some previous treatment for opioid dependency, primarily self-help (59%), inpatient/residential treatment (42%), outpatient counseling (40%), and methadone maintenance (31%). But Dr. Weiss noted that the trial was the first treatment for most subjects.
Treatment success was defined as four or fewer days of opioid use per month, no positive urine screens for opioids for two consecutive weeks, no other formal substance abuse treatment, and no injection of opioids.
In the standard medical management group, only 7% met the criteria for success, as did just 6% of the enhanced medical management group. "Nearly all patients relapsed after a four-week taper," Dr. Weiss said.
Patients who relapsed were asked to enter phase 2, at which time 360 patients were randomly assigned to standard medical management or enhanced medical management and received 3 months of buprenorphine stabilization, then had treatment tapered for one month, with a two-month follow-up.
At the end of the stabilization (at week 12), substantial improvement was noted for 52% of the enhanced medical management group and 47% of the standard medical management group, though there was no additional benefit to enhanced management.
Substantial improvement was defined as abstinence for three or more of the final four weeks of buprenorphine stabilization.
However, by the end of the stabilization period, many patients had relapsed again, Dr. Weiss reported.
"We went from an average success rate of 49% to 26% at week 16,"he said. At week 24, only 9% of patients remained successfully treated.
"At the end of the study, we were back into phase 1 territory," he said. "Seven of eight patients doing well on buprenorphine maintenance had relapsed."
The study also found that the presence of chronic pain did not influence outcomes. Patients with chronic pain were equally likely to enter phase 2 (indicating early treatment failure) and were equally likely to be substantially improved at week 12 of phase 2 (53% vs. 47% for those without chronic pain).
"Interestingly, we found that in many cases the patient’s pain got better," he added, explaining that one cannot assume that buprenorphine itself improved the pain, as there was no control group, but he noted that it is an interesting possibility.
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