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New Clinical Study Shows Efficacy of Home-Based Buprenorphine Treatment for Patients on Clinic Waiting Lists

Timely medication-assisted treatment is of crucial importance for people that suffer from an opioid use disorder and choose to seek help. Pharmacotherapies for these disorders include full mu opioid agonists i.e. methadone, partial opioid agonists i.e. buprenorphine, opioid antagonists i.e. naltrexone as well as alpha-2-adrenergic agonists i.e. lofexidine, which are targeted toward either long-term agonist maintenance therapy or detoxification, with the former currently being the recommended treatment for opioid use disorders.

But despite the clinically proven effectiveness of treatment with opioid agonists, patients still face the risk of overdose, hepatitis, HIV and premature death while waiting for entry in an office-based treatment program. Several US studies support the efficacy of buprenorphine (Suboxone) treatment in a primary care setting and this is primarily attributed to high retention rates and significantly reduced drug injection-related morbidity.

A new clinical study recently published in "The New England Journal of Medicine" shines a light of hope for those who remain on waiting lists, which are typically months long at most clinics. According to this randomized pilot study, the use of interim buprenorphine treatment without counseling can reduce both illicit and prescription opioid use and thus mitigate opioid-related risks including premature death when comprehensive medication-assisted treatment is unavailable. While remaining on waiting lists, 25 participants were randomly chosen to receive interim buprenorphine treatment.

These participants had to visit the clinic every 2 weeks to ingest buprenorphine under medical observation and provide urine samples for toxicologic screening. The remaining doses of buprenorphine were provided through a pre-programmed device which allows buprenorphine administration at home to minimize the risk of non-adherence while still on wait lists.

Stacy Sigmon, Ph.D., a psychologist at the University of Vermont and the study's lead researcher said that the device used in this study was the Med-O-Wheel Secure dispenser (Addoz), a portable, tamper-resistant electronic pill dispenser that allows home use. This disk-shaped pill dispenser makes each day's dose of buprenorphine available only during a pre-programmed 3-hour period. Participants in the treatment group used this device to take buprenorphine in a home setting in order to prevent opioid abuse and curb cravings.

They also received daily calls from researchers to evaluate intravenous opioid use, cravings, and withdrawal through an interactive voice-response phone system, as well as system-generated callbacks. Dr. Sigmon stated that results were downright dramatic, while Dr. Nora Volkow, director of the National Institute on Drug Abuse confirmed the remarkable difference in primary and secondary outcomes for those on clinic waiting lists.

The 25 participants who received buprenorphine submitted a very high percentage of negative urine samples when compared to the other 25 participants in the control group who did not receive this treatment at 4 weeks (88% vs. 0%), 8 weeks (84% vs. 0%), and 12 weeks (68% vs. 0%), which represented the primary outcome.

Likewise, participants in the treatment group had greater reductions in the frequency of use of intravenous opioids, in scores of the opioid and psychiatric subscales of the Addiction Severity Index (ASI). Additionally, adherence to the regimens for buprenorphine administration (99%), daily monitoring calls (96%) as well as random callbacks (96%) was high among participants who received interim buprenorphine, as were ratings of treatment satisfaction.

A partial opioid agonist, buprenorphine attaches to the same mu receptors as Oxycontin, Vicodin, and heroin, but it is different from other opioids due to its safety and pharmacological profile. Used to treat opioid use disorders in the privacy of a clinician's office, buprenorphine can be dispensed by prescription for take-home use, as it has a relatively mild withdrawal profile and lower potential for misuse than full opioid agonists such as methadone.

A grant from the US government paid for this pilot clinical trial, but according to Dr. Sigmon, further studies with longer durations and larger sample sizes are needed to replicate these preliminary, very promising findings. Over half of the participants were able to get into a comprehensive treatment program by the end of this pilot trial. Interim buprenorphine treatment may be suitable for patients living in rural areas where there are limited treatment options.

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