Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence

Prescription opioid dependence is increasing and creates a significant public health burden,
but office-based physicians lack evidence-based guidelines to decide between maintenance or
detoxification treatment with buprenorphine/naloxone. The proposed study compares
buprenorphine/naloxone maintenance (Mtn) vs. detoxification (Dtx) in a 18-week randomized
clinical trail in a heterogeneous population of prescription opioid dependent patients
(N=120) in a primary care clinic. Patients are randomized to Mtn or Dtx after a 2-week
induction period. Mtn is designed to reflect usual care by primary care physicians and
includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be
identical for the first 4 weeks (stabilization) following randomization. In Mtn,
buprenorphine/naloxone will continue unchanged for the remainder of the study. In Dtx, the
dosage of buprenorphine/naloxone will be tapered to zero over the next 3 weeks, and patients
will not receive additional buprenorphine/naloxone for the remainder of the study. Dtx
patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be
offered 7 days following the last dose of Bup. The study will test the hypothesis that Mtn
will lead to decreased illicit drug use and will demonstrate incremental cost-effectiveness
compared to Dtx. Relevance to public health: The results of this study will help define the
role of maintenance vs. detoxification with buprenorphine/naloxone in the care of
prescription opioid dependent patients in primary care.

Inclusion Criteria:

- opioid dependence

Exclusion Criteria:

- current dependence on alcohol, cocaine, benzodiazepines or sedatives

- current suicide or homicide risk

- current psychotic disorder or untreated major depression

- inability to read or understand English

- life-threatening or unstable medical problems