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.
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Drug and Alcohol Dependence 03/2015; · 3.28 Impact Factor
- "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). "
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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. "
ABSTRACT: Withdrawal symptoms are one of the primary reasons people enter a detoxification facility while internal locus of control has been associated with maintenance of sobriety and relapse prevention. The purpose of this study was to determine if a music therapy lyric analysis intervention could affect withdrawal symptoms and locus of control in patients who were in detoxification. Participants (N = 118) were randomized into a music therapy lyric analysis condition or a verbal therapy condition by group. After the session, participants completed a posttest with established psychometric instruments measuring symptoms of withdrawal and locus of control. Although there were no significant differences between groups, results indicated that patients in detoxification facility tended to have slightly less severe withdrawal symptoms after a music therapy session than after a verbal psychotherapy session. Participants in the experimental group tended to have slightly higher mean external of control scores. A greater number of inpatients attended the music therapy sessions than the verbal therapy control sessions, potentially providing implications for funding and billing. Most participants indicated they thought the music therapy (experimental) or relapse prevention (control condition) was most helpful/therapeutic program in which they had participated on the unit. Concerning free response written comments on the posttest, participants in the experimental condition made more comments categorized into the “positive change” category than participants in the control condition. Limitations, implications for clinical practice, and suggestions for future research are provided.The Arts in Psychotherapy 07/2010; 37(3-37):197-201. DOI:10.1016/j.aip.2010.04.001 · 0.58 Impact Factor
- "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"