Cognitive behavioral therapy for anxiety and opioid use disorder: Development and pilot testing.

Introduction: Anxiety disorders are highly prevalent among people with opioid use disorder (OUD), and they have a negative impact on disorder course and treatment outcomes. The objective of this Stage 1 A/1B behavioral treatment development trial was to develop a novel cognitive-behavioral therapy (CBT) protocol for co-occurring anxiety disorders and OUD.

Methods: Following a period of iterative manual development involving patient interviews and feedback from content experts, we tested a 12-session individual CBT protocol in a small, open pilot trial (N = 5). This was followed by a small, randomized controlled trial (N = 32), comparing the new protocol to 12 sessions of manualized Individual Drug Counseling. All participants also received medication for OUD.

Results: Overall, support for feasibility and acceptability was strong, based on recruitment and retention rates and patient satisfaction ratings. Within-subjects results identified 11-point reductions in anxiety symptom severity (on a 0-56 point scale); these gains were sustained through 3 months of follow-up. However, these changes did not differ between randomized conditions. With respect to opioid outcomes, 85 % of participants were abstinent in the prior month at the end of treatment. Opioid use outcomes also did not differ by treatment condition.

Conclusions: These results support the feasibility and acceptability of a CBT protocol for co-occurring anxiety and OUD. However, in this small pilot trial results do not show an initial benefit over an evidence-based psychosocial treatment targeted to OUD alone, in combination with medication for OUD.