Distress Tolerance for Benzodiazepine Discontinuation (DT-BD)

University of Pittsburgh

Status: Terminated

Conditions: Substance Use Disorders

Treatments: Behavioral: Distress Tolerance - Benzodiazepine Discontinuation (DT-BD); Behavioral: Relaxation Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05250570

STUDY21110078

7K23DA044321-06 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Distress Tolerance - Benzodiazepine Discontinuation (DT-BD)

Experimental group

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.

Treatment:

Behavioral: Distress Tolerance - Benzodiazepine Discontinuation (DT-BD)

Relaxation Therapy

Active Comparator group

Description:

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

Treatment:

Behavioral: Relaxation Therapy