Benzodiazepine Discontinuation in Opioid Agonist Therapy (BZD-OAT)

Boston Medical Center (BMC)

Status and phase: Completed; Phase 2

Conditions: Substance Use Disorders

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04109118

H-38981

1K23DA044321-01 (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 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.

Full description

This study pilots a 13-week psychosocial intervention paired with a benzodiazepine taper 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 14 study visits: the first visit consists of the baseline assessment and the first therapy visits, 4 subsequent weekly therapy visits, then 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 starting at the baseline assessment.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 or older
2. Receiving OAT (methadone or buprenorphine) confirmed by toxicology testing for at least 90 days and on a steady dose for 2 consecutive weeks
3. 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
4. Provides permission to contact current BZD prescriber if being prescribed BZDs
5. Speaks English
6. Wants to discontinue BZD use

Exclusion criteria

1. Pregnant, confirmed by urine pregnancy test
2. Cognitive impairment, as indicated by a score of < 23 on the Mini Mental Status Exam
3. Any past month illicit opioid, barbiturate, z-drug, cocaine, unprescribed amphetamine, or synthetic cannabinoid use determined by self-report or urine drug test
4. Receiving ongoing psychosocial treatment for BZD use disorder
5. Uncontrolled seizure disorder (i.e. seizure in prior 90 days), or past BZD withdrawal seizure
6. Current suicidality or homicidality
7. Current psychotic symptoms

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

4 participants in 1 patient group

Distress Tolerance - Benzodiazepine Discontinuation (DT-BD)

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

Treatment:

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

Drug: BZD discontinuation protocol