Interim Buprenorphine vs. Waiting List for Opioid Dependence
Interim Buprenorphine vs. Waiting List for Opioid Dependence
New England Journal of Medicine Letter to the Editor:
NEJM (N Engl J Med 2016; 375:2504-2505December 22, 2016DOI: 10.1056/NEJMc1610047):
Opioid-use disorder has reached epidemic proportions, with high attendant costs in terms of increases in overdoses and infectious diseases and in economic costs.1 Despite the demonstrated efficacy of maintaining abstinence by treating patients with opioid agonists, patients can remain on clinic waiting lists for months, during which time they are at risk of premature death.2 The use of interim treatment with buprenorphine without formal counseling while patients remain on waiting lists may mitigate this risk during delays in treatment.
In a randomized pilot study (ClinicalTrials.gov number, NCT02360007), we evaluated the efficacy of an interim regimen of buprenorphine for reducing illicit opioid use among 50 persons on waiting lists for entry into treatment for opioid abuse. (The protocol is available with the full text of this letter at NEJM.org.)
Participants had used opioids for a mean (±SE) of 7.2±6.1 years, 78% had used intravenous opioids, and 30% had previously overdosed, with an average of 3.6 overdoses each. (Participant characteristics at baseline, including a history of drug use, are listed in the Supplementary Appendix, available at NEJM.org.) While remaining on the waiting list, 25 participants were randomly assigned to receive interim treatment with buprenorphine and 25 participants were not assigned to receive this treatment.
Participants in the treatment group visited the clinic every 2 weeks to provide urine samples for toxicologic screening and to ingest buprenorphine under the observation of the staff. The remaining doses were provided through a computerized dispenser that permitted buprenorphine administration at home to reduce the risk of nonadherence. The device used in the study was the Med-O-Wheel Secure dispenser (Addoz Med-O-Wheel SECURE / e-pill Med-O-Wheel SECURE), a portable, disk-shaped device that makes each day’s dose available during a pre-programmed 3-hour window. Participants in the treatment group also received daily calls to assess drug use, craving, and withdrawal by means of an interactive voice-response telephone system as well as system-generated random callbacks.
Participants in the control group remained on the waiting list of their local clinic and did not receive these services. | Learn more - read the full letter at NEJM.
Stacey C. Sigmon, Ph.D., Taylor A. Ochalek, B.A., Andrew C. Meyer, Ph.D., Bryce Hruska, Ph.D., Sarah H. Heil, Ph.D., Gary J. Badger, M.S., Gail Rose, Ph.D., John R. Brooklyn, M.D., University of Vermont, Burlington, VT University of Vermont Medical Center.
ClinicalTrials.gov number NCT02360007: Interim Buprenorphine: Leveraging Medication + Technology to Bridge Delays in Treatment Access (IBT)
NEJM (N Engl J Med 2016; 375:2504-2505December 22, 2016DOI: 10.1056/NEJMc1610047):
Opioid-use disorder has reached epidemic proportions, with high attendant costs in terms of increases in overdoses and infectious diseases and in economic costs.1 Despite the demonstrated efficacy of maintaining abstinence by treating patients with opioid agonists, patients can remain on clinic waiting lists for months, during which time they are at risk of premature death.2 The use of interim treatment with buprenorphine without formal counseling while patients remain on waiting lists may mitigate this risk during delays in treatment.
In a randomized pilot study (ClinicalTrials.gov number, NCT02360007), we evaluated the efficacy of an interim regimen of buprenorphine for reducing illicit opioid use among 50 persons on waiting lists for entry into treatment for opioid abuse. (The protocol is available with the full text of this letter at NEJM.org.)
Participants had used opioids for a mean (±SE) of 7.2±6.1 years, 78% had used intravenous opioids, and 30% had previously overdosed, with an average of 3.6 overdoses each. (Participant characteristics at baseline, including a history of drug use, are listed in the Supplementary Appendix, available at NEJM.org.) While remaining on the waiting list, 25 participants were randomly assigned to receive interim treatment with buprenorphine and 25 participants were not assigned to receive this treatment.
Participants in the treatment group visited the clinic every 2 weeks to provide urine samples for toxicologic screening and to ingest buprenorphine under the observation of the staff. The remaining doses were provided through a computerized dispenser that permitted buprenorphine administration at home to reduce the risk of nonadherence. The device used in the study was the Med-O-Wheel Secure dispenser (Addoz Med-O-Wheel SECURE / e-pill Med-O-Wheel SECURE), a portable, disk-shaped device that makes each day’s dose available during a pre-programmed 3-hour window. Participants in the treatment group also received daily calls to assess drug use, craving, and withdrawal by means of an interactive voice-response telephone system as well as system-generated random callbacks.
Participants in the control group remained on the waiting list of their local clinic and did not receive these services. | Learn more - read the full letter at NEJM.
Stacey C. Sigmon, Ph.D., Taylor A. Ochalek, B.A., Andrew C. Meyer, Ph.D., Bryce Hruska, Ph.D., Sarah H. Heil, Ph.D., Gary J. Badger, M.S., Gail Rose, Ph.D., John R. Brooklyn, M.D., University of Vermont, Burlington, VT University of Vermont Medical Center.
ClinicalTrials.gov number NCT02360007: Interim Buprenorphine: Leveraging Medication + Technology to Bridge Delays in Treatment Access (IBT)
