Clinical trial NCT04109118: Benzodiazepine Discontinuation in Opioid Agonist Therapy
Official title: Distress Tolerance and Benzodiazepine Discontinuation in Opioid Agonist Therapy, Phase 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Substance Use Disorders
Keywords: Opioid agonist therapy
Benzodiazepine
Distress tolerance
Distress Tolerance - Benzodiazepine Discontinuation (DT-BD)
Relaxation Therapy (RT)
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-09-30
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

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

Primary outcomes:
measure: Participant Acceptability of the Interventions
timeFrame: 13 weeks
measure: Number of Participants Who Rates the Intervention as Feasible
timeFrame: 13 weeks
Secondary outcomes:
measure: Completion of Intervention
timeFrame: 13 weeks
measure: BZD Use Based on Self-report
timeFrame: 13 weeks
measure: Illicit Drug Use Based on Urine Drug Tests
timeFrame: 13 weeks
measure: Alcohol Use Based on Urine Drug Tests
timeFrame: 13 weeks
measure: Alcohol Use Based on Self-report
timeFrame: 13 weeks
measure: BZD Withdrawal Symptoms
timeFrame: 13 weeks
measure: Anxiety Symptoms
timeFrame: 13 weeks
measure: Depressive Symptoms
timeFrame: 13 weeks
measure: Sleep Quality
timeFrame: 13 weeks
measure: Inability to Tolerate Negative States
timeFrame: 13 weeks
measure: Inflexibility or Experiential Avoidance
timeFrame: 13 weeks
measure: Fear of Anxiety Symptoms
timeFrame: 13 weeks
measure: Number of Participants Assessed for Distress Tolerance
timeFrame: 13 weeks
measure: Number of Participants Assessed for Motivations to Use BZD
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Tae Woo Park, MD
role: PRINCIPAL_INVESTIGATOR
References: