A pilot randomized clinical trial evaluating the feasibility, acceptability, and preliminary efficacy of a cognitive-behavioral therapy adjunct to support benzodiazepine tapering among primary care patients coprescribed benzodiazepines and opioids.

Abstract

Objective: Benzodiazepine (BZ) use concerns have escalated in the wake of the opioid crisis, including increased overdose risk from co-use of BZ and opioids. Research evidence to inform clinical management of this issue is currently lacking.

Method: This pilot trial examined acceptability, feasibility, and preliminary efficacy of an intervention approach to reduce BZ use in adults who simultaneously take opioids. Forty participants with concomitant BZ and opioid prescriptions and significant anxiety symptoms were randomized to BZ taper with a cognitive-behavioral therapy protocol (BZT + CBT; n = 20) or BZ taper with a health education control (BZT + HE; n = 20).

Results: Both conditions were rated as logical (M_{BZT + CBT} = 6.20; M_{BZT + HE} = 7.29) and useful (M_{BZT + CBT} = 6.78; MBZT + HE = 5.64), but treatment engagement was modest but similar between conditions. Approximately 60% of participants in both treatment conditions achieved at least a 50% reduction in BZ dose by the 2-month follow-up, reducing the risk of adverse drug-related outcomes. Differences between groups did not reach significance, but effect sizes indicated advantages for BZT + CBT over BZT + HE for anxiety severity at posttreatment (d = 0.86) and follow-up (d = 0.33), with similar findings for pain catastrophizing and anxiety sensitivity.

Conclusions: The promising effect sizes obtained, along with evidence of adequate feasibility and acceptability, encourage further examination of the BZT + CBT approach. (PsycInfo Database Record (c) 2026 APA, all rights reserved).