A community-based, two-phase randomized controlled trial of buprenorphine with and without individual drug counseling for the treatment of opioid analgesic addiction

Prescription opioid addiction is a growing public health problem, yet up to now there has been relatively little systematic evidence on who these patients are, how they differ from heroin dependent patients, and what the best treatment approach is. The NIDA-funded National Drug Abuse Treatment Clinical Trials Network sought to address this gap by conducting the Prescription Opioid Dependence Treatment Study (POATS; CTN-0030) a large, multi-site trial examining duration of buprenorphine treatment, and the role of counseling treatment in addition to medical management, for patients dependent on prescription opioids. Treatment seeking patients (n=653) were recruited at multiple community-based treatment programs across the U.S. A two-phase, adaptive design was used, in which patients were offered a 3-week buprenorphine taper (Phase I), and those who relapsed after taper completion were offered a 3-month buprenorphine stabilization and taper (Phase 2)). In each Phase, patients were randomly assigned to standard medication management with a physician or medication management plus additional counseling. Results presented will include: 1) Characteristics of the population; 2) Characteristics of the subgroup with chronic pain, and how they differ from those without pain; 3) Success rates and relapse rates during and after each of the buprenorphine treatment phases; 4) Whether additional counseling improved treatment outcome over and above standard medical management; and 5) Predictors of treatment outcome.