NCT05250570

Distress Tolerance for Benzodiazepine Discontinuation

Distress Tolerance vs. Relaxation Therapy for Benzodiazepine Discontinuation in Patients Receiving Opioid Agonist Therapy

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The proposed study is a clinical trial, designed to pilot test a Distress Tolerance-Benzodiazepine Discontinuation (DT-BD) intervention for patients on opioid agonist therapy (OAT) who currently use benzodiazepines versus a Relaxation Therapy (RT) control condition. The DT-BD intervention is an adjunctive psychosocial intervention in people seeking to discontinue (BZD) use.

Detailed description

This study pilot tests a 13-week distress tolerance-based psychosocial intervention paired with a benzodiazepine taper comparing it to a relaxation therapy control condition with the aim of assisting individuals receiving OAT discontinue benzodiazepine use. All participants will receive the same benzodiazepine (BZD) discontinuation protocol. The Distress Tolerance-Benzodiazepine Discontinuation (DT-BD) intervention consists of 13 weeks with 5 weekly therapy sessions prior to a 9-week BZD taper. Some participants may be prescribed non-benzodiazepine medications to treat the underlying conditions for which they were using BZDs \[e.g. selective serotonin reuptake inhibitors (SSRI) for anxiety or hypnotics for insomnia\]. Data collection will occur at baseline, then weekly for 13 weeks.

Conditions

• Substance Use Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Distress Tolerance - Benzodiazepine Discontinuation (DT-BD)	This psychosocial treatment intervention uses a combination of interoceptive exposure therapy and elements of acceptance and commitment therapy (ACT) to assist individuals in tolerating benzodiazepine withdrawal symptoms and teaching skills to prevent relapse to benzodiazepine use. It will also provide psychoeducation about benzodiazepine use in OAT. Both intervention and control arms will receive identical benzodiazepine discontinuation taper protocols.
BEHAVIORAL	Relaxation Therapy	The relaxation therapy control condition involves psychoeducation about benzodiazepine use in OAT and progressive muscle-relaxation training. Both intervention and control arms will receive identical benzodiazepine discontinuation taper protocols.

Timeline

• Start date: 2022-06-17
• Primary completion: 2022-12-09
• Completion: 2022-12-09
• First posted: 2022-02-22
• Last updated: 2023-01-30

Locations

3 sites across 1 country: United States