Distress Tolerance for Benzodiazepine Discontinuation

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.

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

Conditions
-----------------
Substance Use Disorders

Intervention / Treatment
-----------------
* Behavioral: Distress Tolerance - Benzodiazepine Discontinuation (DT-BD)
* Behavioral: Relaxation Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Distress Tolerance - Benzodiazepine Discontinuation (DT-BD)<br>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. | Behavioral: Distress Tolerance - Benzodiazepine Discontinuation (DT-BD)<br>* 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.<br>|
| Active Comparator: Relaxation Therapy<br>The relaxation therapy control condition involves psychoeducation about benzodiazepine use in OAT and progressive muscle-relaxation training. | Behavioral: Relaxation Therapy<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quantity of BZD use | Change in quantity of BZD used define by past-week BZD use by self-report in diazepam equivalent dose | 4- and 6-months | 
| Change in distress tolerance | 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. | 4- and 6-months |