Topiramate Augmenting Strategies for the Treatment of Alcohol Use Disorder

Early Phase 1CompletedNCT03120468

Nassima Ait-Daoud Tiouririne17 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Alcoholism

Interventions

Topiramate and N-Acetyl CysteineDRUG

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

Topiramate and PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UVA Center for Leading Edge Addiction Research

Charlottesville, Virginia, United States

Outcomes

Primary Outcomes

Cognitive side effects

Collection of self-report cognitive side effects

Time frame: up to13 weeks

Secondary Outcomes

Percent Heavy Drinking Days (PHDD)

The timeline follow-back (TLFB) method of measuring alcohol consumption will be used for Percent Heavy Drinking Days (PHDD).

Time frame: up to 13 weeks

Drinks per Drinking Day

Additional measures of self-reported drinking outcomes

Time frame: up to 13 weeks

Percentage of Days Abstinent

Additional measures of self-reported drinking outcomes

Time frame: up to 13 weeks

Obsessive compulsive drinking scale (OCDS)

measurement of craving

Time frame: up to 16 weeks

Drinking Inventory of Consequence (DrInC) scale

measurement of psychosocial consequences of drinking

Time frame: DrInC is at screen, weeks 1,5,9, and 13

Clinical Global Improvement (CGI) scale

Increase in overall clinical improvement

Time frame: up to 16 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.