Benzodiazepine Discontinuation in Opioid Agonist Therapy

NCT04109118 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: H-389811K23DA044321-01
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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 who currently use benzodiazepines. The DT-BD intervention is an adjunctive psychosocial intervention in people seeking to discontinue (BZD) use. The goal of the study is to assess the applicability and feasibility of this intervention through treatment retention and qualitative interviews with four participants who are receiving opioid agonist treatment and who regularly use BZDs.

Conditions

Substance Use Disorders

Keywords

Opioid agonist therapy; Benzodiazepine; Distress tolerance; Distress Tolerance - Benzodiazepine Discontinuation (DT-BD); Relaxation Therapy (RT)

Outcome Measures

Primary Outcomes (2)

• Participant Acceptability of the Interventions

  Number of participants who rated the intervention as acceptable, this was assessed by conducting an in-depth exit interview with the participant once they complete the entire 13-week study.

  13 weeks

• Number of Participants Who Rates the Intervention as Feasible

  Feasibility of intervention will be measured through the number of participants recruited and enrolled in the study, number of participants who started the BZD taper, and completed assessment tools.

  13 weeks

Secondary Outcomes (14)

• Completion of Intervention

  13 weeks

• BZD Use Based on Self-report

  13 weeks

• Illicit Drug Use Based on Urine Drug Tests

  13 weeks

• Alcohol Use Based on Urine Drug Tests

  13 weeks

• Alcohol Use Based on Self-report

  13 weeks

Study Arms (1)

Distress Tolerance - Benzodiazepine Discontinuation (DT-BD)

OTHER

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. Of note, this is a pilot trial for feasibility and acceptability. There is no randomization and we are not comparing arms.

Behavioral: Distress Tolerance - Benzodiazepine Discontinuation (DT-BD); Drug: BZD discontinuation protocol

Interventions

Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) BEHAVIORAL

Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) is a psychosocial intervention. It is paired with a benzodiazepine taper. The aim of the psychosocial intervention is to improve individuals' ability to tolerate distress in order to assist benzodiazepine discontinuation in patients treated with OAT. There will be 5 sessions between therapist and participant prior to the start of the benzodiazepine taper. The taper for both the intervention and control conditions occurs over 9 weeks and involves weekly meetings with a benzodiazepine prescriber during which a gradual benzodiazepine dose reduction will take place. The DT-BD intervention combines elements of existing psychosocial interventions. Specifically, interoceptive exposure techniques will be paired with elements of acceptance and commitment therapy (ACT) and relapse prevention (RP).

Distress Tolerance - Benzodiazepine Discontinuation (DT-BD)

BZD discontinuation protocol DRUG

All participants will undergo BZD discontinuation. Once the starting BZD dose is determined by prescription monitoring and/or self-report, we will maintain participants on this dose until the start of the BZD taper. Participants will see a study physician weekly to receive their BZD medication for the week until the taper is completed. BZD discontinuation in this study will consist of a gradual BZD taper in dose over 9 weeks. The taper will be flexible in that the study physician will utilize clinical judgement to lengthen the taper if necessary, depending on the severity of the participant's withdrawal symptoms. Anchor points will be set (33% reduction in dose after 2 weeks, 50% mid-treatment, 100% by week 8) to emphasize the time-limited nature of the taper.

Also known as: Benzodiazepine

Distress Tolerance - Benzodiazepine Discontinuation (DT-BD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Receiving OAT (methadone or buprenorphine) confirmed by toxicology testing for at least 90 days and on a steady dose for 2 consecutive 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

You may not qualify if:

• Pregnant, confirmed by urine pregnancy test
• Cognitive impairment, as indicated by a score of \< 23 on the Mini Mental Status Exam
• Any past month illicit opioid, barbiturate, z-drug, cocaine, unprescribed amphetamine, or synthetic cannabinoid use determined by self-report or urine drug test
• 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

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Benzodiazepines

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

There was an intended sample of four participants, and only one out of the four participants completed the whole 13-week study. This is due to the barrier of coming in-person for their weekly appointment during the peak of COVID-19 pandemic when the vaccines were just becoming available to the public.

Results Point of Contact

• Title: Tae Woo Park, MD
• Organization: Boston Medical Center and BU School of Medicine

taewoo.park@bmc.org

617-414-1906

Study Officials

• Tae Woo Park, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 30, 2019
• Study Start: March 18, 2021
• Primary Completion: July 8, 2021
• Study Completion: July 8, 2021
• Last Updated: February 11, 2022
• Results First Posted: February 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)