Benzodiazepine Discontinuation in Opioid Agonist Therapy
Condition: Substance Use Disorders
MeSH terms: Substance-Related Disorders
Intervention: Distress Tolerance - Benzodiazepine Discontinuation (DT-BD); BZD discontinuation protocol
Intervention description: 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).; 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Opioid agonist therapy; Benzodiazepine; Distress tolerance; Distress Tolerance - Benzodiazepine Discontinuation (DT-BD); Relaxation Therapy (RT)

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:

          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