Distress Tolerance vs. Relaxation Therapy for Benzodiazepine Discontinuation in Patients Receiving Opioid Agonist Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Pittsburgh
- Enrollment
- 1
- Locations
- 6
- Primary Endpoint
- Number of participants who discontinued BZDs at 4-month follow-up
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Number of participants who discontinued BZDs at 4-month follow-up
Time Frame: 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
Time Frame: 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 Outcomes
- Change in quantity of BZD use(4- and 6-months)
- Change in distress tolerance(4- and 6-months)
Investigators
Tae Woo Park
Assistant Professor
University of Pittsburgh