Recruiting PHASE2 Opioid Use Disorder

New treatment option for Opioid Use Disorder

Official title Evaluating Buspirone to Treat Opioid Withdrawal

ClinicalTrials.gov ID: NCT05511909

What this study is testing

What is Buspirone?

Buspirone is an investigational medicine, given as an once-daily, being studied as a potential treatment for opioid use disorder.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The investigators propose a rigorous, Phase II, three-group, placebo-controlled double-blind randomized controlled trial (RCT) to evaluate the efficacy of buspirone for both withdrawal and craving among individuals with opioid use disorder (OUD) undergoing a standardized stepwise taper. During this 10 to 12-day residential study, participants with OUD will be enrolled, stabilized on a short-acting opioid, undergo an opioid stepwise taper, and complete a post-taper observation period where participants will have the opportunity to initiate long-term buprenorphine or extended-release naltrexone.
  • Phase 2: a mid-size study of how well it works
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 75

You may be able to join if

  • Aged 18-75
  • Opioid positive urine sample
  • Current moderate-severe opioid use disorder with evidence of physical dependence
  • Interested in undergoing opioid detoxification

You likely can't join if

  • Being pregnant or breastfeeding
  • Enrolled in methadone or buprenorphine maintenance treatment
  • Allergic to study medication or taking medications that are contraindicated with study medication (e.g., CYP3A4 inhibitors or inducers and/or...
  • Significant mental health or physical disorder, or life circumstance, that is expected to interfere with study participation (detailed further in...
  • Hypotension and/or prolonged QTc interval

The study team makes the final eligibility decision.

Where it's taking place

  • Baltimore, Maryland, United States

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.