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NCT05511909 · ClinicalTrials.gov registry record · Phase 2
Evaluating Buspirone to Treat Opioid Withdrawal
A Phase 2 study of Anxiety and Opioid Use Disorder, sponsored by Johns Hopkins University.
- Active
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT05511909: Active Phase 2 study of Anxiety and Opioid Use Disorder, sponsored by Johns Hopkins University.
NCT05511909 is a Phase 2 study of Anxiety and Opioid Use Disorder that is active but no longer recruiting, run by Johns Hopkins University. The registered enrollment target is 100 participants, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05511909, a Phase 2 study of Anxiety and Opioid Use Disorder, is active but no longer recruiting, sponsored by Johns Hopkins University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Buspirone
- DRUG Lofexidine
Study Locations (1)
Maryland
- Behavioral Pharmacology Research Unit - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-12-15 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 2 |
What the registry record for NCT05511909 still lists
NCT05511909 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (77% lower).
The record links to 4 conditions, with Anxiety appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05511909 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05511909 about?
NCT05511909 is a clinical study titled "Evaluating Buspirone to Treat Opioid Withdrawal". 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 ...
What is the current status of trial NCT05511909?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2022-12-15. Estimated completion is 2027-03-31.
What conditions does trial NCT05511909 study?
This clinical trial studies the following conditions: Anxiety, Opioid Use Disorder, Opioid Withdrawal, Opioid Craving.
What interventions are being tested in trial NCT05511909?
The interventions under investigation include: Placebo (DRUG), Buspirone (DRUG), Lofexidine (DRUG).
Who is sponsoring clinical trial NCT05511909?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05511909 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05511909's enrollment target sits among peer trials
100 162nd of 364 higher than 188 of 364 other Anxiety trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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