OBJECTIVE: To compare the clinical efficacy of different doses of levomethadyl acetate hydrochloride (known as LAAM) in the treatment of opioid dependence. DESIGN: A randomized controlled, double-blind, parallel group, 17-week study. SETTING:Outpatient facilities at Johns Hopkins University Bayview Medical Center, Baltimore, Md. PATIENTS: Opioid-dependent volunteers (N=180) applying to a treatment-research clinic. INTERVENTION: Thrice-weekly (Monday/Wednesday/Friday) oral LAAM dose conditions of 25/25/35 mg, 50/50/70 mg, and 100/100/140 mg and nonmandatory counseling. MAIN OUTCOME MEASURES: Retention in treatment, self-reported heroin use, and opioid-positive urine specimens. RESULTS: Retention was independent of subjects' sex and dose. Self-reported heroin use decreased in a dose-related manner. At final assessment, patients in the high-dose condition reported using heroin 2.5 of 30 days as compared with 4.1 or 6.3 days for patients in the medium-dose and low-dose conditions, respectively (high dose vs low dose, P<.05); urinalysis results were similarly dose related. Overall, 20 (34%) of 59 patients in the high-dose condition remained opioid-abstinent for 4 consecutive weeks, as compared with 8 (14%) of 59 in the medium-dose and 7 (11%) of 62 in the low-dose conditions (P<.01). Self-report and urinalysis data are consistent with a greater than 90% reduction in illicit opioid use by the high-dose group relative to pretreatment levels. CONCLUSION: Opioid substitution treatment with LAAM substantially reduces illicit opioid use. The clinical efficacy of LAAM is positively related to dose.
RCT Entities:
OBJECTIVE: To compare the clinical efficacy of different doses of levomethadyl acetate hydrochloride (known as LAAM) in the treatment of opioid dependence. DESIGN: A randomized controlled, double-blind, parallel group, 17-week study. SETTING:Outpatient facilities at Johns Hopkins University Bayview Medical Center, Baltimore, Md. PATIENTS: Opioid-dependent volunteers (N=180) applying to a treatment-research clinic. INTERVENTION: Thrice-weekly (Monday/Wednesday/Friday) oral LAAM dose conditions of 25/25/35 mg, 50/50/70 mg, and 100/100/140 mg and nonmandatory counseling. MAIN OUTCOME MEASURES: Retention in treatment, self-reported heroin use, and opioid-positive urine specimens. RESULTS: Retention was independent of subjects' sex and dose. Self-reported heroin use decreased in a dose-related manner. At final assessment, patients in the high-dose condition reported using heroin 2.5 of 30 days as compared with 4.1 or 6.3 days for patients in the medium-dose and low-dose conditions, respectively (high dose vs low dose, P<.05); urinalysis results were similarly dose related. Overall, 20 (34%) of 59 patients in the high-dose condition remained opioid-abstinent for 4 consecutive weeks, as compared with 8 (14%) of 59 in the medium-dose and 7 (11%) of 62 in the low-dose conditions (P<.01). Self-report and urinalysis data are consistent with a greater than 90% reduction in illicit opioid use by the high-dose group relative to pretreatment levels. CONCLUSION: Opioid substitution treatment with LAAM substantially reduces illicit opioid use. The clinical efficacy of LAAM is positively related to dose.
Authors: Brittany B Dennis; Pavel S Roshanov; Leen Naji; Monica Bawor; James Paul; Carolyn Plater; Guillaume Pare; Andrew Worster; Michael Varenbut; Jeff Daiter; David C Marsh; Dipika Desai; Zainab Samaan; Lehana Thabane Journal: Trials Date: 2015-10-21 Impact factor: 2.279
Authors: Brittany B Dennis; Monica Bawor; Leen Naji; Carol K Chan; Jaymie Varenbut; James Paul; Michael Varenbut; Jeff Daiter; Carolyn Plater; Guillaume Pare; David C Marsh; Andrew Worster; Dipika Desai; Lehana Thabane; Zainab Samaan Journal: Subst Abuse Date: 2015-09-10