Recruiting
Phase 2

Buspirone

Sponsor:

University of Maryland, Baltimore

Code:

NCT05511909

Conditions

Opioid Use Disorder

Opioid Withdrawal

Opioid Craving

Anxiety

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Buspirone

Lofexidine

Placebo

Study Details

Brief summary:

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.

Conditions

Opioid Use Disorder

Opioid Withdrawal

Opioid Craving

Anxiety

Study ID

NCT05511909

Start date

Dec 15, 2022

Status verified date

Aug, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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 monoamine oxidase (MAO) inhibitors)
  • Significant mental health or physical disorder, or life circumstance, that is expected to interfere with study participation (detailed further in protection of human subjects form).
  • Hypotension and/or prolonged QTc interval

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: opioid stepwise taper + buspirone

up to 45mg/day buspirone during the opioid stepwise taper

active comparator: opioid stepwise taper + lofexidine

up to 2.16mg/day lofexidine during the opioid stepwise taper

placebo comparator: opioid stepwise taper + placebo

placebo during the opioid stepwise taper

Interventions

Buspirone

Buspirone administration begins 2 days prior to opioid taper (study day -2) and continues until the second day of the post-taper observation phase (study day 7).

Lofexidine

Lofexidine administration begins 2 days prior to opioid taper (study day -2) and continues until the second day of the post-taper observation phase (study day 7).

Placebo

Participants administration begins 2 days prior to opioid taper (study day -2) and continues until the second day of the post-taper observation phase (study day 7).

Primary outcome measure

  • Change in Opioid Withdrawal as assessed by the Subjective Opiate Withdrawal Scale (SOWS) [ Time Frame: Days -2 to 8 ]

Central Contacts and Locations

Central contacts

Cecilia Bergeria, Ph.D.

410-550-1979cberge21@jhmi.edu

Caitlyn Grubb, B.S.

410-550-0490cgrubb7@jhmi.edu

Locations

Kahlert Institute for Addictino Medicin

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Cecilia Bergeria, Ph.D.

410-550-1979cberge21@jhmi.edu

Principal Investigator:

Cecilia Bergeria, Ph.D.

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-08-24.