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Anxiolytic

Buspirone for Opioid Withdrawal

Phase 2
Recruiting
Led By Cecilia Bergeria, Ph.D.
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18-75
Be older than 18 years old
Must not have
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)
Hypotension and/or prolonged QTc interval
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days -2 to 8

Summary

This trial will test if buspirone can help people with opioid use disorder who are going through a stepwise taper.

Who is the study for?
This trial is for adults aged 18-75 with opioid use disorder who are physically dependent on opioids and want to detox. They must have a positive urine test for opioids but can't be pregnant, breastfeeding, or have low blood pressure or heart issues. People taking certain other meds or with serious mental/physical health problems that could affect their participation are also excluded.
What is being tested?
The study tests the effectiveness of Buspirone in managing withdrawal symptoms and cravings during opioid detoxification compared to Lofexidine and a placebo. Participants will undergo a controlled tapering off opioids over 10-12 days in a residential setting, followed by an observation period where they may start long-term addiction treatments.
What are the potential side effects?
While not specified here, common side effects of Buspirone include dizziness, nausea, headache, nervousness, lightheadedness, and excitement. Side effects from Lofexidine may include low blood pressure, slow heart rate, drowsiness, dry mouth and sleep disturbance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not allergic to the study medication and am not taking any drugs that could interfere with it.
Select...
I have low blood pressure or a heart rhythm issue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days -2 to 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and days -2 to 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Opioid Withdrawal as assessed by the Subjective Opiate Withdrawal Scale (SOWS)
Secondary study objectives
Acceptability of buspirone for opioid withdrawal and craving
Change in cue-induced craving scores
Change in stress-induced craving scores
+3 more

Side effects data

From 2016 Phase 4 trial • 175 Patients • NCT00875836
49%
Other
41%
Dizziness or lightheaded
41%
Gastrointestinal
32%
Headache
22%
Congestion
19%
Drowsiness
18%
Insomnia
15%
Sinus/allergies/flu
13%
Musculoskeletal
5%
Anxiety or Depression
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Buspirone

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: opioid stepwise taper + buspironeExperimental Treatment1 Intervention
up to 45mg/day buspirone during the opioid stepwise taper
Group II: opioid stepwise taper + lofexidineActive Control1 Intervention
up to 2.16mg/day lofexidine during the opioid stepwise taper
Group III: opioid stepwise taper + placeboPlacebo Group1 Intervention
placebo during the opioid stepwise taper
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Buspirone
2022
Completed Phase 4
~1160

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,573 Total Patients Enrolled
Cecilia Bergeria, Ph.D.Principal InvestigatorJohns Hopkins University

Media Library

Buspirone (Anxiolytic) Clinical Trial Eligibility Overview. Trial Name: NCT05511909 — Phase 2
Opioid Withdrawal Syndrome Research Study Groups: opioid stepwise taper + lofexidine, opioid stepwise taper + placebo, opioid stepwise taper + buspirone
Opioid Withdrawal Syndrome Clinical Trial 2023: Buspirone Highlights & Side Effects. Trial Name: NCT05511909 — Phase 2
Buspirone (Anxiolytic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05511909 — Phase 2
Opioid Withdrawal Syndrome Patient Testimony for trial: Trial Name: NCT05511909 — Phase 2
~51 spots leftby Jan 2027
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