Clinical trial

Evaluating a Mechanistically-Supported Pharmacotherapy to Treat Opioid Withdrawal

NCT05511909

Name

IRB00315529

Description

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.

Trial arms

Trial start

2022-12-15

Estimated PCD

2027-01-31

Trial end

2027-03-31

Status

Recruiting

Phase

Early phase I

Treatment

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).

Arms:

opioid stepwise taper + buspirone

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).

Arms:

opioid stepwise taper + lofexidine

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).

Arms:

opioid stepwise taper + placebo

Size

100

Primary endpoint

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

Days -2 to 8

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2023-12-14

1 organization

3 products

4 indications

Organization

Johns Hopkins University

Product

Buspirone

Indication

Opioid Use Disorder

Indication