Topiramate Augmenting Strategies for the Treatment of Alcohol Use Disorder

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).

Study Overview

• Status: Unknown
• Conditions: Alcoholism
• Intervention / Treatment: Drug: Topiramate and N-Acetyl Cysteine; Drug: Topiramate and Placebo

Detailed Description

This is a pilot study designed to evaluate the safety, tolerability of Topiramate (TPM) + N-Acetyl Cysteine (NAC) in combination versus Topiramate (TPM) + placebo in 16 subjects enrolled in a 12 week, randomized, double-blind, outpatient trial. Each subject will receive randomly one of the drug combinations for 12 weeks plus medication management.

Primary Aim 1: To evaluate the safety, tolerability of Topiramate (TPM) and N-Acetyl Cysteine (NAC) in combination or Topiramate (TPM) + placebo for the treatment of Alcohol Use Disorder (AUD). This aim will be accomplished by testing the following:

•Hypothesis 1 - The combination of Topiramate (TPM) and N-Acetyl Cysteine (NAC) will be well tolerated by participants as evidenced by less self-report cognitive side effects (word finding difficulties, difficulties with concentration, and confusion).

Secondary Aim 1: The combination of Topiramate (TPM) and N-Acetyl Cysteine (NAC) or Topiramate (TPM) + Placebo will reduce alcohol drinking. This aim will be accomplished by testing the following:

•Hypothesis 2 - The combination of Topiramate (TPM) and N-Acetyl Cysteine (NAC) or Topiramate (TPM) + Placebo will reduced alcohol drinking , as evidenced by a statistically significant reduction in percentage of heavy drinking days (PHDD) as compared to baseline.

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • UVA Center for Leading Edge Addiction Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

Please contact site for additional information

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topiramate and N-Acetyl Cysteine; Drug: Topiramate and N-Acetyl Cysteine Other Name for Topiramate: Topamax	Drug: Topiramate and N-Acetyl Cysteine; Topiramate up to 200 mg/day and N-Acetyl Cysteine 600 mg twice a day for 12 weeks; Other Names: Topamax
Experimental: Topiramate and Placebo; Drug: Topiramate and Placebo Other Name for Topiramate: Topamax Other Name for Placebo: Sugar Pill	Drug: Topiramate and Placebo; Topiramate up to 200 mg/day and Placebo for 12 weeks; Other Names: Topamax; Sugar Pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive side effects	Collection of self-report cognitive side effects	up to13 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Heavy Drinking Days (PHDD)	The timeline follow-back (TLFB) method of measuring alcohol consumption will be used for Percent Heavy Drinking Days (PHDD).	up to 13 weeks
Drinks per Drinking Day	Additional measures of self-reported drinking outcomes	up to 13 weeks
Percentage of Days Abstinent	Additional measures of self-reported drinking outcomes	up to 13 weeks
Obsessive compulsive drinking scale (OCDS)	measurement of craving	up to 16 weeks
Drinking Inventory of Consequence (DrInC) scale	measurement of psychosocial consequences of drinking	DrInC is at screen, weeks 1,5,9, and 13
Clinical Global Improvement (CGI) scale	Increase in overall clinical improvement	up to 16 weeks

Collaborators and Investigators

• Sponsor: Nassima Ait-Daoud Tiouririne

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: April 14, 2017
• First Posted (Actual): April 19, 2017

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 25, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: alcohol, alcohol dependence, addiction, alcohol use disorder
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Protective Agents; Anticonvulsants; Respiratory System Agents; Antioxidants; Antidotes; Free Radical Scavengers; Expectorants; Acetylcysteine; N-monoacetylcystine; Topiramate
• Other Study ID Numbers: 19422

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No