New soluble-film preparations of buprenorphine suppressed heroin abusers’ withdrawal symptoms with no serious side effects in a recent clinical trial. These preparations offer potential advantages over currently used tablet forms of the medication. They dissolve more rapidly in the mouth, providing faster relief from withdrawal symptoms, and they can be packaged in single-dose units that make diversion for purposes of abuse more difficult and accidental ingestion by children less likely.
Dr. Eric C. Strain and colleagues at the Johns Hopkins School of Medicine in Baltimore tested a soluble-film preparation of buprenorphine as a facilitator of the transition from short-acting opioids (such as those used in illicit or prescription opioid abuse) to opioid maintenance therapy. They recruited 34 men and women who had used heroin for an average of 9.8 years and had taken the drug an average of 27.5 of the 30 days prior to entering the study. After stabilizing the participants on subcutaneous injections of 30 mg of morphine four times daily for 5 to 8 days, the researchers substituted placebo to induce mild opioid withdrawal. Twenty-one hours after their last active morphine dose, 18 participants received an initial dose of the soluble-film buprenorphine preparation, and 16 participants received buprenorphine plus naloxone. Among both groups, participants’ reported discomfort and observers’ ratings on the Clinical Opiate Withdrawal Scale declined by half within 1 hour and fell to minimal levels after 2 hours. Over the next 4 days, the researchers successfully stabilized participants on a therapeutic buprenorphine dose adequate to control symptoms. Few participants dropped out of the study, and there was no significant difference in the response to buprenorphine alone versus buprenorphine with naloxone.
Clinical Pharmacology and Therapeutics 89(3):443–449, 2011. Abstract Available