Evaluating Buspirone to Treat Opioid Withdrawal

NCT05511909 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IRB00315529
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 Withdrawal; Opioid Craving; Anxiety; Opioid Use Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Opioid Withdrawal as assessed by the Subjective Opiate Withdrawal Scale (SOWS)

  Opioid withdrawal severity will be measured with the Subjective Opiate Withdrawal Scale (SOWS) and will be computed as a daily peak total SOWS score for study days -2 to 8. The SOWS consists of 16 opioid withdrawal symptoms that are assessed for severity on a scale from 0-4 ("Not at all" to "Extremely"). Total scores range from 0-64 where a score between 0-10 is considered mild, between 11-20 is considered moderate, and greater than 21 is considered severe.

  Days -2 to 8

Secondary Outcomes (6)

• Change in tonic craving scores

  Days -2 to 8

• Change in cue-induced craving scores

  Days -2 to 8

• Change in stress-induced craving scores

  Days -2 to 8

• Frequency of Adverse Events

  Up to day 8

• Frequency of QTc Interval Prolongation

  Up to day 8

Study Arms (3)

opioid stepwise taper + buspirone

EXPERIMENTAL

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

Drug: Buspirone

opioid stepwise taper + lofexidine

ACTIVE COMPARATOR

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

Drug: Lofexidine

opioid stepwise taper + placebo

PLACEBO COMPARATOR

placebo during the opioid stepwise taper

Drug: Placebo

Interventions

Buspirone DRUG

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).

opioid stepwise taper + buspirone

Lofexidine DRUG

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).

opioid stepwise taper + lofexidine

Placebo DRUG

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).

opioid stepwise taper + placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Kahlert Institute for Addictino Medicin

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders; Anxiety Disorders

Interventions

Buspirone; lofexidine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Polycyclic Compounds

Study Officials

• Cecilia Bergeria, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cecilia Bergeria, Ph.D.

CONTACT

410-550-1979; cberge21@jhmi.edu

Caitlyn Grubb, B.S.

CONTACT

410-550-0490; cgrubb7@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 23, 2022
• Study Start: March 15, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)