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Distress Tolerance for Benzodiazepine Discontinuation (DT-BD)

Primary Purpose

Substance Use Disorders

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Distress Tolerance - Benzodiazepine Discontinuation (DT-BD)

Relaxation Therapy

About this trial

This is an interventional treatment trial for Substance Use Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Center for Psychiatric and Chemical Dependency Services (CPCDS)
Internal Medicine Recovery Engagement Program (REP)
Narcotic Addiction Treatment Program (NATP)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Distress Tolerance - Benzodiazepine Discontinuation (DT-BD)

Relaxation Therapy

Arm Description

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.

The relaxation therapy control condition involves psychoeducation about benzodiazepine use in OAT and progressive muscle-relaxation training.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT05250570

First Posted

January 31, 2022

Last Updated

January 26, 2023

Sponsor

University of Pittsburgh

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT05250570

Brief Title

Distress Tolerance for Benzodiazepine Discontinuation

Acronym

DT-BD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Terminated

Why Stopped

Difficulty with recruitment

Study Start Date

June 17, 2022 (Actual)

Primary Completion Date

December 9, 2022 (Actual)

Study Completion Date

December 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Substance Use Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Distress Tolerance - Benzodiazepine Discontinuation (DT-BD)

Arm Type

Experimental

Arm Description

Arm Title

Relaxation Therapy

Arm Type

Active Comparator

Arm Description

The relaxation therapy control condition involves psychoeducation about benzodiazepine use in OAT and progressive muscle-relaxation training.

Intervention Type

Behavioral

Intervention Name(s)

Distress Tolerance - Benzodiazepine Discontinuation (DT-BD)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Relaxation Therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of participants who discontinued BZDs at 4-month follow-up

Description

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.

Time Frame

4-months

Title

Number of participants who discontinued BZDs at 6-month follow-up

Description

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.

Time Frame

6-months

Secondary Outcome Measure Information:

Title

Change in quantity of BZD use

Description

Change in quantity of BZD used define by past-week BZD use by self-report in diazepam equivalent dose

Time Frame

4- and 6-months

Title

Change in distress tolerance

Description

Time Frame

4- and 6-months

Other Pre-specified Outcome Measures:

Title

BZD withdrawal symptoms

Description

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.

Time Frame

4- and 6-months

Title

Anxiety symptoms

Description

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.

Time Frame

4- and 6-months

Title

Depressive symptoms

Description

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.

Time Frame

4- and 6-months

Title

Inflexibility or experiential avoidance

Description

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.

Time Frame

4- and 6-months

Title

Distress tolerance

Description

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.

Time Frame

4- and 6-months

Title

Fear of anxiety symptoms

Description

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.

Time Frame

4- and 6-months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tae Woo Park, MD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for Psychiatric and Chemical Dependency Services (CPCDS)

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Internal Medicine Recovery Engagement Program (REP)

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15219

Country

United States

Facility Name

Narcotic Addiction Treatment Program (NATP)

City

Wilkinsburg

State/Province

Pennsylvania

ZIP/Postal Code

15221

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Distress Tolerance for Benzodiazepine Discontinuation

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