Topiramate Augmenting Strategies for the Treatment of Alcohol Use Disorder

NCT03120468 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 19422
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Alcoholism

Keywords

alcohol, alcohol dependence, addiction, alcohol use disorder

Outcome Measures

Primary Outcomes (1)

• Cognitive side effects

  Collection of self-report cognitive side effects

  up to13 weeks

Secondary Outcomes (6)

• 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

Study Arms (2)

Topiramate and N-Acetyl Cysteine

EXPERIMENTAL

Drug: Topiramate and N-Acetyl Cysteine Other Name for Topiramate: Topamax

Drug: Topiramate and N-Acetyl Cysteine

Topiramate and Placebo

EXPERIMENTAL

Drug: Topiramate and Placebo Other Name for Topiramate: Topamax Other Name for Placebo: Sugar Pill

Drug: Topiramate and Placebo

Interventions

Topiramate and N-Acetyl Cysteine DRUG

Topiramate up to 200 mg/day and N-Acetyl Cysteine 600 mg twice a day for 12 weeks

Also known as: Topamax

Topiramate and N-Acetyl Cysteine

Topiramate and Placebo DRUG

Topiramate up to 200 mg/day and Placebo for 12 weeks

Also known as: Topamax; Sugar Pill

Topiramate and Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females
• Ages 18 and above
• Good physical health
• Current DSM-V diagnosis of alcohol use disorder
• Currently drinking ≥21 alcohol units/week for women and ≥28 alcohol units/week for men on average in the last 28 days prior to screen.
• Be seeking treatment for problems with alcohol
• Be able to take oral medication and be willing to adhere to the medication regimen.
• Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
• Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may substantially interfere with study participation.
• Not have any unresolved legal problems that could jeopardize continuation or completion of the study.
• The pregnancy test for females at screen and prior to randomization must be negative. Additionally, women of childbearing potential must be using an acceptable form of contraception. These include: oral contraceptives, hormonal (levonorgestrel) or surgical implants, or barrier plus spermicide.

You may not qualify if:

• Please contact site for additional information

Sponsors & Collaborators

• Nassima Ait-Daoud Tiouririne: lead

Study Sites (1)

UVA Center for Leading Edge Addiction Research

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Alcoholism; Behavior, Addictive

Interventions

Topiramate; Acetylcysteine; Sugars

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Carbohydrates; Ketoses; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Nassima Ait-Daoud Tiouririne, M.D.

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Director of UVA Center for Leading Edge Addiction Research

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 19, 2017
• Study Start: May 1, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)