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NCT03547622 · ClinicalTrials.gov registry record · Early Phase 1
Galantamine and CBT4CBT Pilot to Prevent Relapse.
A Early Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 6
- Enrollment target
NCT03547622: Completed Early Phase 1 study, sponsored by Yale University.
NCT03547622 is a Early Phase 1 study that has completed, run by Yale University. The registered enrollment target is 6 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03547622, a Early Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The investigators are proposing a randomized pilot feasibility study to evaluate the effects of galantamine versus placebo on preventing relapse to opioid use following tapering from methadone or buprenorphine maintenance (Medication Assisted Treatment, or MAT) among adults with opioid use disorder, with additional behavioral therapy (web-based cognitive behavioral therapy) provided across all conditions to help individuals successfully transition from MAT to a drug-free state.
Primary Outcome
Number of participants who were able to taper to 0 mg from methadone or buprenorphine over 10 weeks of treatment. Data about current medication and dose in mg was collected at the start of treatment (week 1) was recorded on a weekly medical sheet. Data was then collected weekly from participant self-report and verified through the clinic database.
Interventions
- DRUG MAT taper with galantamine
- DRUG MAT taper with placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2018-05-01 |
| Est. Completion | 2019-02-28 |
| Phase | Early Phase 1 |
What the finished NCT03547622 record still lists
NCT03547622 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which MAT taper with galantamine is the first listed.
NCT03547622 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03547622 about?
NCT03547622 is a clinical study titled "Galantamine and CBT4CBT Pilot to Prevent Relapse.". The investigators are proposing a randomized pilot feasibility study to evaluate the effects of galantamine versus placebo on preventing relapse to opioid use following tapering from methadone or buprenorphine maintenance (Medication Assisted Treatment, or MAT) among adults with opioid use disorder,...
What is the current status of trial NCT03547622?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 6 participants. The study started on 2018-05-01. Estimated completion is 2019-02-28.
What interventions are being tested in trial NCT03547622?
The interventions under investigation include: MAT taper with galantamine (DRUG), MAT taper with placebo (DRUG).
Who is sponsoring clinical trial NCT03547622?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03547622's enrollment target sits among peer trials
6 1845th of 2000 higher than 114 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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