NCT02252068

Study of Treatment for Opioid Dependence and Anxiety Disorders

Behavioral Treatment Development for Co-occurring Opioid Dependence and Anxiety Disorders

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Mclean Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Anxiety is highly prevalent among individuals with opioid dependence and confers greater risk for continued opioid use and poor treatment outcomes. However, there are currently no efficacious treatments available for co-occurring opioid dependence and anxiety. The ultimate aims of this trial are the development and testing of a novel integrated cognitive behavioral treatment (I-CBT) for co-occurring opioid dependence and anxiety disorders. This clinical trial consists of two phases: (1) open-trial pilot (2) randomized control trial. We hypothesize that I-CBT will be a feasible and acceptable treatment that will result in significant reductions in anxiety and opioid use.

Detailed description

This Stage 1 behavioral treatment development trial involves two stages: manual development and pilot testing in an open trial, and a small randomized controlled trial. In both phases, opioid use and anxiety symptoms will be measured as the primary clinical outcome, along with measures of feasibility and patient satisfaction. These results will be used to further refine the treatment manual and to evaluate whether this treatment may enhance outcomes for adults with co-occurring opioid dependence and anxiety disorders.

Conditions

• Anxiety Disorders
• Opiate Addiction

Interventions

Type	Name	Description
BEHAVIORAL	I-CBT	New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.
BEHAVIORAL	IDC	Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.

Timeline

• Start date: 2015-01-01
• Primary completion: 2019-10-24
• Completion: 2019-12-19
• First posted: 2014-09-29
• Last updated: 2020-11-17
• Results posted: 2020-11-17

Locations

1 site across 1 country: United States