Distress Tolerance for Benzodiazepine Discontinuation

Not Applicable

Terminated

• Conditions: Substance Use Disorders

• 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

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