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NCT05096117 · ClinicalTrials.gov registry record · Phase 2
Human Laboratory Study of ASP8062 for Alcohol Use Disorder
A Phase 2 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT05096117 is a Phase 2 study that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 60 participants.
The verdict
NCT05096117, a Phase 2 study, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the effects of ASP8062, 25 mg once a day and matched placebo, on alcohol cue-elicited alcohol craving during a human laboratory paradigm after 2 weeks 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 objectives include evaluation of ASP8062, 25 mg once a day, and matched placebo on reduction of alcohol consumption, alcohol craving, cigarette smoking (among smokers), 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
- DRUG ASP8062
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-12-13 |
| Est. Completion | 2023-03-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05096117
The ClinicalTrials.gov registry entry for NCT05096117 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 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 is the first listed.
NCT05096117 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05096117 about?
NCT05096117 is a clinical study titled "Human Laboratory Study of ASP8062 for Alcohol Use Disorder". The primary objective of this study is to evaluate the effects of ASP8062, 25 mg once a day and matched placebo, on alcohol cue-elicited alcohol craving during a human laboratory paradigm after 2 weeks of daily dosing among subjects with moderate to severe alcohol use disorder (AUD) as confirmed by ...
What is the current status of trial NCT05096117?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2021-12-13. Estimated completion is 2023-03-22.
What interventions are being tested in trial NCT05096117?
The interventions under investigation include: Placebo (DRUG), ASP8062 (DRUG).
Who is sponsoring clinical trial NCT05096117?
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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