NCT03120468|CompletedEarly Phase 1FDA Drug
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Sponsor study identifier
interventional
17
1 country
1
Study Start
May 1, 2017
Actual (reported)Primary Completion
June 30, 2019
Actual (reported)Study Completion
June 30, 2019
Actual (reported)This is a pilot study designed to evaluate the safety, tolerability of Topiramate (TPM) + N-Acetyl Cysteine (NAC) in combination versus Topiramate (TPM) + placebo for the treatment of alcohol use disorder (AUD).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 31, 2017
Actual (reported)April 19, 2017
Actual (reported)May 1, 2017
Actual (reported)June 30, 2019
Actual (reported)June 30, 2019
Actual (reported)Cognitive side effects
Collection of self-report cognitive side effects
up to13 weeks
Percent Heavy Drinking Days (PHDD)
up to 13 weeks
Drinks per Drinking Day
up to 13 weeks
Percentage of Days Abstinent
up to 13 weeks
Obsessive compulsive drinking scale (OCDS)
up to 16 weeks
Drinking Inventory of Consequence (DrInC) scale
DrInC is at screen, weeks 1,5,9, and 13
Drug: Topiramate and N-Acetyl Cysteine Other Name for Topiramate: Topamax
Drug: Topiramate and Placebo Other Name for Topiramate: Topamax Other Name for Placebo: Sugar Pill
Topiramate up to 200 mg/day and N-Acetyl Cysteine 600 mg twice a day for 12 weeks
Topiramate up to 200 mg/day and Placebo for 12 weeks
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Topiramate and N-Acetyl Cysteine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordUVA Center for Leading Edge Addiction Research
Charlottesville, Virginia, 22903, United States
Nassima Ait-Daoud Tiouririne, M.D.
University of Virginia
17 participants (actual enrollment reported by the registry).
First Submitted
March 31, 2017
First Posted
April 19, 2017
Study Start
May 1, 2017
Actual (reported)Exploring Gut-Brain and Brain-Gut Interactions in Alcohol Use Disorder Via Microbiota Investigations: A Pilot Study
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 30, 2019
Actual (reported)Study Completion
June 30, 2019
Actual (reported)Last Updated
May 27, 2026
Record last verified: 2026-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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