Phase 2
N=4
Benzodiazepine Discontinuation in Opioid Agonist Therapy
Substance Use Disorders
Bottom Line
View on ClinicalTrials.gov: NCT04109118 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Participant Acceptability of the Interventions — 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) (Behavioral); BZD discontinuation protocol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Medical Center
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant Acceptability of the Interventions |
1; 0 | — |
| PRIMARY Number of Participants Who Rates the Intervention as Feasible |
1 | — |
| SECONDARY Completion of Intervention |
1 | — |
| SECONDARY BZD Use Based on Self-report |
0; 1 | — |
| SECONDARY Illicit Drug Use Based on Urine Drug Tests |
0; 1 | — |
| SECONDARY Alcohol Use Based on Urine Drug Tests |
1; 0 | — |
| SECONDARY Alcohol Use Based on Self-report |
0; 1 | — |
| SECONDARY BZD Withdrawal Symptoms |
1; 0; 0 | — |
| SECONDARY Anxiety Symptoms |
1; 0 | — |
| SECONDARY Depressive Symptoms |
1; 0 | — |
| SECONDARY Sleep Quality |
1; 0 | — |
| SECONDARY Inability to Tolerate Negative States |
3 | — |
| SECONDARY Inflexibility or Experiential Avoidance |
3 | — |
| SECONDARY Fear of Anxiety Symptoms |
10 | — |
| SECONDARY Number of Participants Assessed for Distress Tolerance |
1; 0 | — |
| SECONDARY Number of Participants Assessed for Motivations to Use BZD |
1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04109118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.