Laam dose comparison: A clinical trial

LAAM is the most recently approved pharmacotherapy for opioid dependence. To date, there have been no clinical trials assessing the dose effectiveness of LAAM. Purpose: To assess the effectiveness of three LAAM dose conditions. Methods: Opioid-dependent subjects (N=180) were stratified and randomly assigned to a 29 wk double-blind clinical trial comparing three, thrice-weekly (M/W/F) LAAM dose conditions. Subjects in the low (N=62), medium (N=59), and high (N=59) dose conditions received 25/25/35, 50/50/70, and 100/100/140 mg, respectively. Primary outcome measures assessed through the maintenance period (wk 17) were: 1) overall percent negative (a) opioid and (b) cocaine urine specimens, 2) percent of subjects with 12 consecutive opioid negative urine specimens, and 3) treatment retention. Results: Significant differences were observed across conditions for measures 1a and 2. Overall urine specimens negative for opioids were, 23.1%, 32.4%, and 40.8% and the percent of patients able to provide 12 consecutive opioid negative urine specimens were 11%, 20%, and 32% for the low, medium, and high dose conditions, respectively. There were no differences between conditions for measures 1b and 3. Conclusion: The effectiveness of LAAM treatment on rates of opioid negative urine specimens increases with increasing LAAM dose.