title: A double-blind, double-dummy, randomized, prospective pilot study of the partial mu opiate agonist, buprenorphine, for acute detoxification from heroin.
abstract: The optimum dose of buprenorphine for acute inpatient heroin detoxification has not been determined. This randomized, double-blind, double-dummy, pilot study compares two buprenorphine sublingual tablet dosing schedules to oral clonidine. Heroin users (N = 30) who met DSM-IV criteria for opioid dependence and achieved a Clinical Opiate Withdrawal Scale (COWS) score of 13 (moderate withdrawal), were randomized to receive higher dose buprenorphine (HD, 8-8-8-4-2 mg/day on days 1-5), lower dose buprenorphine (LD, 2-4-8-4-2 mg/day on days 1-5), or clonidine (C, 0.2-0.3-0.3-0.2-0.1 mg QID on days 1-5). COWS scores were obtained QID. Twenty-four hours after randomization, the percentages of subjects who achieved suppression of withdrawal, as defined by four consecutive COWS scores <12, were: C = 11%, LD = 40%, and HD = 60%. Generalized estimating equation regression models, controlling for baseline COWS and time, indicated that COWS scores over the course of 5 days were lower in both LD and HD compared to C (chi(2)(2) = 13.28, P = 0.001). Similar analyses examining scores over time on the Adjective Rating Scale for Withdrawal (ARSW) and on a Visual Analog Scale of Opiate Craving (VAS) indicated an overall treatment effect on the VAS accounted for by a significant difference between HD and C, but no overall treatment effect on the ARSW. There were no discontinuations due to treatment-related adverse events. Both HD and LD regimens are safe and efficacious treatment for opioid detoxification, but HD demonstrated superiority to C on a greater number of measures.
authors.affiliation: Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, and Veterans Affairs Puget Sound Healthcare System, 1660 South Columbian Way, Seattle, WA 98108, USA.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Oreskovich
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Saxon
authors.forename: Mei Ling K
authors.initials: ML
authors.lastname: Ellis
authors.forename: Carol A
authors.initials: CA
authors.lastname: Malte
authors.forename: Joseph P
authors.initials: JP
authors.lastname: Reoux
authors.forename: Patricia C
authors.initials: PC
authors.lastname: Knox
mesh_terms: D000328:Adult; D000701:Analgesics, Opioid / Q000494:pharmacology / Q000627:therapeutic use*; D000704:Analysis of Variance; D002047:Buprenorphine / Q000494:pharmacology / Q000627:therapeutic use*; D003000:Clonidine / Q000494:pharmacology / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006556:Heroin Dependence / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D017450:Receptors, Opioid, mu / Q000819:agonists* / Q000502:physiology; D013997:Time Factors
chemical_list: D000701:Analgesics, Opioid; D017450:Receptors, Opioid, mu; D002047:Buprenorphine; D003000:Clonidine