Moderate- vs high-dose methadone in the treatment of opioid dependence - Arandomized trial

Context Methadone hydrochloride treatment is the most common pharmacologica l intervention for opioid dependence, and recent interest has focused on ex panding methadone treatment availability beyond traditional specially licen sed clinics. However, despite recommendations regarding effective dosing of methadone, controlled clinical trials of higher-dose methadone have not be en conducted. Objective To compare the relative clinical efficacy of moderate- vs high-do se methadone in the treatment of opioid dependence. Design A 40-week randomized, double-blind clinical trial starting in June 1 992 and ending in October 1995. Setting Outpatient substance abuse treatment research clinic at the Johns H opkins University Bayview Campus, Baltimore, Md. Participants One hundred ninety-two eligible clinic patients. Intervention Daily oral methadone hydrochloride in the dose range of 40 to 50 mg (n = 97) or 80 to 100 mg (n = 95), with concurrent substance abuse co unseling. Main Outcome Measures Opioid-positive urinalysis results and retention in t reatment. Results By intent-to-treat analysis, through week 30 patients in the high-d ose group had significantly lower rates of opioid-positive urine samples co mpared with patients in the moderate-dose group (53.0% [95 % confidence int erval {Cl}, 46.9% -59.2 %] vs 61.9% [95 % CI, 55.9 % -68.0 %]; P = .047). T hese differences persisted during withdrawal from methadone, Through day 21 0 no significant difference was evident between dose groups in treatment re tention (high-dose group mean retention, 159 days; moderate-dose group mean retention, 157 days), Nineteen (33%) of 57 patients in the high-dose group and 11 (20%) of 54 patients in the moderate-dose group completed detoxific ation. Conclusions Both moderate- and high-dose methadone treatment resulted in de creased illicit opioid use during methadone maintenance and detoxification, The high-dose group had significantly greater decreases in illicit opiod u se.