A randomized trial of cognitive behavioral therapy in primary care-based buprenorphine

Am J Med. 2013 Jan;126(1):74.e11-7. doi: 10.1016/j.amjmed.2012.07.005.


Objective: To determine the impact of cognitive behavioral therapy on outcomes in primary care, office-based buprenorphine/naloxone treatment of opioid dependence.

Methods: We conducted a 24-week randomized clinical trial in 141 opioid-dependent patients in a primary care clinic. Patients were randomized to physician management or physician management plus cognitive behavioral therapy. Physician management was brief, manual guided, and medically focused; cognitive behavioral therapy was manual guided and provided for the first 12 weeks of treatment. The primary outcome measures were self-reported frequency of illicit opioid use and the maximum number of consecutive weeks of abstinence from illicit opioids, as documented by urine toxicology and self-report.

Results: The 2 treatments had similar effectiveness with respect to reduction in the mean self-reported frequency of opioid use, from 5.3 days per week (95% confidence interval, 5.1-5.5) at baseline to 0.4 (95% confidence interval, 0.1-0.6) for the second half of maintenance (P<.001 for the comparisons of induction and maintenance with baseline), with no differences between the 2 groups (P=.96) or between the treatments over time (P=.44). For the maximum consecutive weeks of opioid abstinence there was a significant main effect of time (P<.001), but the interaction (P=.11) and main effect of group (P=.84) were not significant. No differences were observed on the basis of treatment assignment with respect to cocaine use or study completion.

Conclusions: Among patients receiving buprenorphine/naloxone in primary care for opioid dependence, the effectiveness of physician management did not differ significantly from that of physician management plus cognitive behavioral therapy.

Trial registration: ClinicalTrials.gov NCT00632151.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Analgesics, Opioid / therapeutic use*
  • Buprenorphine / therapeutic use*
  • Cognitive Behavioral Therapy*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Opiate Substitution Treatment*
  • Opioid-Related Disorders / drug therapy*
  • Patient Compliance
  • Primary Health Care*
  • Treatment Outcome
  • Young Adult


  • Analgesics, Opioid
  • Buprenorphine

Associated data

  • ClinicalTrials.gov/NCT00632151