Clinical trial NCT05250570: Distress Tolerance for Benzodiazepine Discontinuation
Official title: Distress Tolerance vs. Relaxation Therapy for Benzodiazepine Discontinuation in Patients Receiving Opioid Agonist Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Substance Use Disorders
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-02-22
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 (OAT) who currently use benzodiazepines versus a Relaxation Therapy (RT) control condition. The DT-BD intervention is an adjunctive psychosocial intervention in people seeking to discontinue (BZD) use.

Detailed description: This study pilot tests a 13-week distress tolerance-based psychosocial intervention paired with a benzodiazepine taper comparing it to a relaxation therapy control condition 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 13 weeks with 5 weekly therapy sessions prior to 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 at baseline, then weekly for 13 weeks.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Receiving OAT (methadone or buprenorphine) for at least 2 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
* Capacity to provide informed consent

Exclusion Criteria:

* Pregnant, confirmed by urine pregnancy test
* Cognitive impairment, as indicated by Montreal Cognitive Assessment (MoCA): must score at least 26 on the MoCA with a one-point adjustment for individuals with formal education of 12 years or fewer
* Any past month illicit opioid determined by self-report or urine drug test; illicit defined as non-medical use
* 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

Primary outcomes:
measure: Number of participants who discontinued BZDs at 4-month follow-up
timeFrame: 4-months
measure: Number of participants who discontinued BZDs at 6-month follow-up
timeFrame: 6-months
Secondary outcomes:
measure: Change in quantity of BZD use
timeFrame: 4- and 6-months
measure: Change in distress tolerance
timeFrame: 4- and 6-months
Other outcomes:
measure: BZD withdrawal symptoms
timeFrame: 4- and 6-months
measure: Anxiety symptoms
timeFrame: 4- and 6-months
measure: Depressive symptoms
timeFrame: 4- and 6-months
measure: Inflexibility or experiential avoidance
timeFrame: 4- and 6-months
measure: Distress tolerance
timeFrame: 4- and 6-months
measure: Fear of anxiety symptoms
timeFrame: 4- and 6-months
Locations:
city: Pittsburgh
country: United States
facility: Center for Psychiatric and Chemical Dependency Services (CPCDS)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Internal Medicine Recovery Engagement Program (REP)
state: Pennsylvania
city: Wilkinsburg
country: United States
facility: Narcotic Addiction Treatment Program (NATP)
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Tae Woo Park, MD
role: PRINCIPAL_INVESTIGATOR
References: