Dose-related efficacy of levomethadyl acetate for treatment of opioid dependence. A randomized clinical trial
T. Eissenberg, G. E. Bigelow, E. C. Strain, S. L. Walsh, R. K. Brooner, M. L. Stitzer and R. E. Johnson
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD 21224-6823, USA.
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.
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