Study Stopped
Difficulty with recruitment
Distress Tolerance for Benzodiazepine Discontinuation
DT-BD
Distress Tolerance vs. Relaxation Therapy for Benzodiazepine Discontinuation in Patients Receiving Opioid Agonist Therapy
2 other identifiers
interventional
1
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2022
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2022
CompletedFirst Posted
Study publicly available on registry
February 22, 2022
CompletedStudy Start
First participant enrolled
June 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 9, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 9, 2022
CompletedJanuary 30, 2023
January 1, 2023
6 months
January 31, 2022
January 26, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Number of participants who discontinued BZDs at 4-month follow-up
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.
4-months
Number of participants who discontinued BZDs at 6-month follow-up
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.
6-months
Secondary Outcomes (2)
Change in quantity of BZD use
4- and 6-months
Change in distress tolerance
4- and 6-months
Other Outcomes (6)
BZD withdrawal symptoms
4- and 6-months
Anxiety symptoms
4- and 6-months
Depressive symptoms
4- and 6-months
- +3 more other outcomes
Study Arms (2)
Distress Tolerance - Benzodiazepine Discontinuation (DT-BD)
EXPERIMENTALThis 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.
Relaxation Therapy
ACTIVE COMPARATORThe relaxation therapy control condition involves psychoeducation about benzodiazepine use in OAT and progressive muscle-relaxation training.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (3)
Center for Psychiatric and Chemical Dependency Services (CPCDS)
Pittsburgh, Pennsylvania, 15213, United States
Internal Medicine Recovery Engagement Program (REP)
Pittsburgh, Pennsylvania, 15219, United States
Narcotic Addiction Treatment Program (NATP)
Wilkinsburg, Pennsylvania, 15221, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tae Woo Park, MD
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 31, 2022
First Posted
February 22, 2022
Study Start
June 17, 2022
Primary Completion
December 9, 2022
Study Completion
December 9, 2022
Last Updated
January 30, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share