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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03970109
The ClinicalTrials.gov registry entry for NCT03970109 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo oral tablet is the first listed.
NCT03970109 reports 0 study locations.
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.
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