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A double-blind, double-dummy, randomized, prospective pilot study of the partial mu opiate agonist, buprenorphine, for acute detoxification from heroin.

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.
Drug and Alcohol Dependence (Impact Factor: 3.28). 02/2005; 77(1):71-9. DOI: 10.1016/j.drugalcdep.2004.07.008
Source: PubMed

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.

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    • "When considering the available pharmacotherapies for use in opioid detoxification, the partial mu-opioid agonist buprenorphine has a pharmacological profile that lends toward its use in taper regimens. Buprenorphine has a long plasma half-life and slow dissociation from the receptor (Hambrook and Rance, 1976; Jasinski et al., 1978; Bullingham et al., 1980; Bickel et al., 1988a; Fudala et al., 1990), which results in a more limited withdrawal syndrome when compared to other full opioid agonists (e.g., methadone; Jasinski et al., 1978; Bickel et al., 1988b; Fudala et al., 1990) and adrenergic agonists (e.g., clonidine; Janiri et al., 1994; O'Connor et al., 1997; Lintzeris et al., 2002; Ling et al., 2005; Marsch et al., 2005; Oreskovich et al., 2005). However, despite the data suggesting a favorable withdrawal profile for buprenorphine over other medications, few studies have directly evaluated the time course and severity of withdrawal during buprenorphine detoxification, and the existing studies on this topic have generally failed to account for ongoing illicit opioid and ancillary medication use that can confound assessments of opioid withdrawal (Dunn et al., 2011). "
    Drug and Alcohol Dependence 03/2015; · 3.28 Impact Factor
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    • "Thus, the higher the score, the worse the symptoms of withdrawal. This instrument has been used by a number of prominent researchers due to its convenience, practicality , and usability (Amass, Kamien, & Mikulich, 2000; Bickel et al., 1988a, 1988b; Oreskovich et al., 2005). Due to the subjective and temporal aspects of withdrawal symptoms, however, psychometric data concerning validity and reliability do not exist. "
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    • "s were recorded in each arm , with a death in each arm ( neither related to study medication ) and in the out - patient group , 18 SAEs were recorded . Fourteen of these were in the buprenorphine - naltrexone arm . Ten were continued substance abuse / overdose , 2 were depression and one each were severe vomiting and admission for spinal surgery . Oreskovich et al . ( 2005 ) performed a randomized , double - blind study to compare two buprenorphine dosing schedules to clonidine . The two dosing schedules were 8mg per day on days 1 to 3 , then dropped to 4 and 2mg on the next two days ( referred to as higher dose ) and 2 - 4 - 8 - 4 - 2mg per day on days 1 to 5 ( referred to as lower dose ) . Ancillary med"
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