TerminatedNot Applicable

Distress Tolerance for Benzodiazepine Discontinuation

Stopped: Difficulty with recruitment

United States1 participantsStarted 2022-06-17

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants who discontinued BZDs at 4-month follow-up

Timeframe: 4-months

Number of participants who discontinued BZDs at 6-month follow-up

Timeframe: 6-months

Trial details

NCT IDNCT05250570

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-09

View on ClinicalTrials.gov More Substance Use Disorders trials