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A Randomized Clinical Trial

Thomas Eissenberg, PhD; George E. Bigelow, PhD; Eric C. Strain, MD; Sharon L. Walsh, PhD; Robert K. Brooner, PhD; Maxine L. Stitzer, PhD; Rolley E. Johnson, PharmD

JAMA. 1997;277(24):1945-1951.

Abstract
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 opioidabstinent 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.

Author Affiliations
From the Behavioral Pharmacology Research Unit, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Md. Dr Eissenberg is now with the Department of Psychology and Center for Drug and Alcohol Studies, Virginia Commonwealth University, Richmond.

Footnotes
Dr Johnson is a paid consultant for Roxane Laboratories, Inc, Columbus, Ohio.

Reprints: Rolley E. Johnson, PharmD, Johns Hopkins University School of Medicine, Department of Psychiatry and Behavioral Sciences, Behavioral Pharmacology Research Unit, 5510 Nathan Shock Dr, Baltimore, MD 21224-6823 (e-mail: rejohnson@bpru.uucp.jhu.edu).

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