Buspirone for Anxiety

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Behavioral Pharmacology Research Unit, Baltimore, MD
Anxiety+5 More
Buspirone - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Opioid Withdrawal (Disorder)
  • Opioid Craving
  • Anxiety
  • Opioid Use Disorder (OUD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Days -2 to 8

Days -2 to 8
Change in Opioid Withdrawal as assessed by the Subjective Opiate Withdrawal Scale (SOWS)
Change in cue-induced craving scores
Change in stress-induced craving scores
Change in tonic craving scores
Up to day 8
Acceptability of buspirone for opioid withdrawal and craving
Frequency of Adverse Events
Frequency of QTc Interval Prolongation

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Buspirone
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
This histogram enumerates side effects from a completed 2016 Phase 4 trial (NCT00875836) in the Buspirone ARM group. Side effects include: Other with 49%, Dizziness or lightheaded with 41%, Gastrointestinal with 41%, Headache with 32%, Congestion with 22%.

Trial Design

3 Treatment Groups

opioid stepwise taper + lofexidine
1 of 3
opioid stepwise taper + buspirone
1 of 3
opioid stepwise taper + placebo
1 of 3
Active Control
Experimental Treatment
Non-Treatment Group

100 Total Participants · 3 Treatment Groups

Primary Treatment: Buspirone · Has Placebo Group · Phase 2

opioid stepwise taper + buspirone
Drug
Experimental Group · 1 Intervention: Buspirone · Intervention Types: Drug
opioid stepwise taper + lofexidine
Drug
ActiveComparator Group · 1 Intervention: Lofexidine · Intervention Types: Drug
opioid stepwise taper + placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Buspirone
2022
Completed Phase 4
~1240

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: days -2 to 8
Closest Location: Behavioral Pharmacology Research Unit · Baltimore, MD
Photo of Baltimore 1Photo of Baltimore 2Photo of Baltimore 3
2008First Recorded Clinical Trial
1 TrialsResearching Anxiety
17 CompletedClinical Trials

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,033 Previous Clinical Trials
30,782,299 Total Patients Enrolled
14 Trials studying Anxiety
3,460 Patients Enrolled for Anxiety
Cecilia Bergeria, Ph.D.Principal InvestigatorJohns Hopkins University

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are aged 18-75.
You have opiate positive urine sample.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.