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NCT03970109 · ClinicalTrials.gov registry record · Phase 2
HLAB-002 of ANS-6637 for Alcohol Use Disorder
A Phase 2 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Terminated
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT03970109: Clinical Trial Phase 2 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
NCT03970109 is a Phase 2 study that was terminated before completion, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03970109, a Phase 2 study, was terminated before completion, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study Summary
Primary: The primary objective of this study was to evaluate the effects of 2 different doses of ANS-6637, 200 mg (given as 2 x 100 mg tablets) and 600 mg (given as 2 x 300 mg tablets) once a day, and matched placebo, on alcohol cue-elicited alcohol craving during a human laboratory paradigm after 1 week of daily dosing among subjects with moderate to severe alcohol use disorder (AUD) as confirmed by the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5™). Secondary: Secondary objectives included evaluation of ANS-6637 200 mg, ANS-6637 600 mg, and matched placebo on reduction of alcohol consumption, alcohol craving, cigarette smoking (among smokers) and nicotine use (among nicotine users), mood, sleep, alcohol use negative consequences, study retention, and safety and tolerability throughout the last 4 weeks of the treatment phase of the study.
Primary Outcome
The primary efficacy endpoint is the change in the "strength" of alcohol craving Visual Analog Scale (VAS) score for the question, "How strong is your craving to drink alcohol," in response to an alcohol cue at Week 2 - after one week of investigational product treatment. The VAS has a minimum=0 and maximum=20 with higher values indicative of greater craving for alcohol (a worse outcome).
Interventions
- DRUG Placebo oral tablet
- DRUG ANS-6637
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2019-10-08 |
| Est. Completion | 2020-05-22 |
| Phase | Phase 2 |
Why NCT03970109 stopped before completion
NCT03970109 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral tablet is the first listed.
NCT03970109 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03970109 about?
NCT03970109 is a clinical study titled "HLAB-002 of ANS-6637 for Alcohol Use Disorder". Primary: The primary objective of this study was to evaluate the effects of 2 different doses of ANS-6637, 200 mg (given as 2 x 100 mg tablets) and 600 mg (given as 2 x 300 mg tablets) once a day, and matched placebo, on alcohol cue-elicited alcohol craving during a human laboratory paradigm after 1...
What is the current status of trial NCT03970109?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2019-10-08. Estimated completion is 2020-05-22.
What interventions are being tested in trial NCT03970109?
The interventions under investigation include: Placebo oral tablet (DRUG), ANS-6637 (DRUG).
Who is sponsoring clinical trial NCT03970109?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03970109's enrollment target sits among peer trials
43 1332nd of 2000 higher than 662 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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