Distress Tolerance for Benzodiazepine Discontinuation (DT-BD)

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

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.

Study Overview

• Status: Terminated
• Conditions: Substance Use Disorders
• Intervention / Treatment: Behavioral: Distress Tolerance - Benzodiazepine Discontinuation (DT-BD); Behavioral: Relaxation Therapy

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Center for Psychiatric and Chemical Dependency Services (CPCDS)
    • Pittsburgh, Pennsylvania, United States, 15219
      • Internal Medicine Recovery Engagement Program (REP)
    • Wilkinsburg, Pennsylvania, United States, 15221
      • Narcotic Addiction Treatment Program (NATP)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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) 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.
Active Comparator: Relaxation Therapy; The relaxation therapy control condition involves psychoeducation about benzodiazepine use in OAT and progressive muscle-relaxation training.	Behavioral: Relaxation Therapy; 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.

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
BZD withdrawal symptoms	BZD withdrawal symptoms will be measured using the Clinical Institute Withdrawal Assessment-Benzodiazepines (CIWA-B). The CIWA-B is a 20-item instrument, to assess severity of benzodiazepine withdrawal, including nausea and vomiting, anxiety, tremor, sweating, auditory disturbances, visual disturbances, tactile disturbances, headache, agitation, and clouding of sensorium. Scores range from 0 to 80, with 1-20 mild withdrawal, 21-40 moderate withdrawal, 41-60 severe withdrawal, and 61-80 very severe withdrawal.	4- and 6-months
Anxiety symptoms	Anxiety symptoms will be measured using the Beck Anxiety Inventory (BAI), a 21-item self report inventory for measuring severity of anxiety. The items probe about common symptoms of anxiety that the participant may have experienced in the past week, including numbness, tingling, sweating, and fear. Each item is scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The standardized cutoffs are: 0-7: minimal anxiety, 8-15: mild anxiety, 16-25: moderate anxiety, and 26-63: severe anxiety.	4- and 6-months
Depressive symptoms	Depressive symptoms will be measured using the Beck Depression Inventory-II, a 21-item self report inventory measuring the severity of depression. The items probe on common symptoms of depression including hopelessness, irritability, guilt, weight-loss, fatigue, or lack of interest in daily activities. Higher total scores indicate more severe depressive symptoms. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.	4- and 6-months
Inflexibility or experiential avoidance	The Acceptance and Action Questionnaire-II will be used to measure inflexibility or experiential avoidance. It is a 7-item self-report measure of psychological inflexibility or experiential avoidance. Each of the 7 items can be rated on a scale of 1 (never true) to 7 (always true) so scores can range from 7 to 49. Higher scores equal greater levels of psychological inflexibility.	4- and 6-months
Distress tolerance	Distress tolerance will be assessed with the computerized Mirror Tracing Persistence Task (MTPT-C). It is a computerized version of the original Mirror Tracing Persistence Task in which trace multiple progressively difficult polygons, with participants free to terminate at any point. Distress tolerance is measured by the latency in seconds to task termination. Higher latency indicates greater distress tolerance.	4- and 6-months
Fear of anxiety symptoms	Fear of anxiety symptoms will be assessed by the Anxiety Sensitivity Index. It is a 16-item scale with each item rated on a five-point Likert scale ranging from 0 (very little) to 4 (very much). Scores can range from 0 to 64. Higher scores reflect greater fear of anxiety symptoms.	4- and 6-months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Tae Woo Park, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2022
• Primary Completion (Actual): December 9, 2022
• Study Completion (Actual): December 9, 2022

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: February 10, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: STUDY21110078; 7K23DA044321-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No