Evaluating Buspirone to Treat Opioid Withdrawal

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT05511909
Phase
PHASE2
Status
Recruiting
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Conditions

  • Anxiety
  • Opioid Craving
  • Opioid Use Disorder
  • Opioid Withdrawal

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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).
  • 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).
  • 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).

Study Details

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.

Key Dates

Start date
Mar 15, 2023
Status verified
Apr 2026
Primary completion
Jan 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kahlert Institute for Addictino MedicinBaltimoreMaryland21224
Cecilia Bergeria, Ph.D.
[email protected]
410-550-1979
Cecilia Bergeria, Ph.D. (PRINCIPAL_INVESTIGATOR)

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Kahlert Institute for Addictino Medicin· Baltimore, MD

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