Distress Tolerance for Benzodiazepine Discontinuation

Not Applicable

Terminated

• Conditions: Substance Use Disorders
• Interventions: Behavioral: Relaxation Therapy; Behavioral: Distress Tolerance - Benzodiazepine Discontinuation (DT-BD)

• Registration Number: NCT05250570
• Lead Sponsor: University of Pittsburgh

Brief 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.

Study Timeline

• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-02-10
• Study First Posted: 2022-02-22
• Study Start: 2022-06-17
• Primary Completion: 2022-12-09
• Study Completion: 2022-12-09
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Age 18 or older
• Receiving OAT (methadone or buprenorphine) for at least 2 weeks
• Regular BZD use defined by BZD use 3 or more times per week in past month by self-report and positive urine screen at time of recruitment
• Provides permission to contact current BZD prescriber if being prescribed BZDs
• Speaks English
• Wants to discontinue BZD use
• Capacity to provide informed consent

Exclusion Criteria

• Pregnant, confirmed by urine pregnancy test
• Cognitive impairment, as indicated by Montreal Cognitive Assessment (MoCA): must score at least 26 on the MoCA with a one-point adjustment for individuals with formal education of 12 years or fewer
• Any past month illicit opioid determined by self-report or urine drug test; illicit defined as non-medical use
• Receiving ongoing psychosocial treatment for BZD use disorder
• Uncontrolled seizure disorder (i.e. seizure in prior 90 days), or past BZD withdrawal seizure
• Current suicidality or homicidality
• Current psychotic symptoms

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Relaxation Therapy	Relaxation Therapy	The relaxation therapy control condition involves psychoeducation about benzodiazepine use in OAT and progressive muscle-relaxation training.
Distress Tolerance - Benzodiazepine Discontinuation (DT-BD)	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) and psychoeducation about benzodiazepine use in OAT.

Primary Outcome Measures

Name	Time	Method
Number of participants who discontinued BZDs at 4-month follow-up	4-months	Number of participants with BZD discontinuation defined by no BZD use by self-report during the month prior to 4-month follow-up corroborated by urine testing.
Number of participants who discontinued BZDs at 6-month follow-up	6-months	Number of participants with BZD discontinuation defined by no BZD use by self-report during the month prior to 6-month follow-up corroborated by urine testing.

Secondary Outcome Measures

Name	Time	Method
Change in quantity of BZD use	4- and 6-months	Change in quantity of BZD used define by past-week BZD use by self-report in diazepam equivalent dose
Change in distress tolerance	4- and 6-months	Change in distress tolerance defined by change in Distress Intolerance Index (DII) score from baseline to 6 month follow-up. The DII is a 10-item instrument. Items are rated from 0 (very little) to 4 (very much) and are summed for a total score (range 0-40), with higher scores indicating worse ability to tolerate distress.

Trial Locations

Locations (3)

Center for Psychiatric and Chemical Dependency Services (CPCDS); 🇺🇸 Pittsburgh, Pennsylvania, United States

Internal Medicine Recovery Engagement Program (REP); 🇺🇸 Pittsburgh, Pennsylvania, United States

Narcotic Addiction Treatment Program (NATP); 🇺🇸 Wilkinsburg, Pennsylvania, United States