Topiramate Augmenting Strategies for the Treatment of Alcohol Use Disorder

Nassima Ait-Daoud Tiouririne

Status and phase: Unknown; Early Phase 1

Conditions: Alcoholism

Treatments: Drug: Topiramate and N-Acetyl Cysteine; Drug: Topiramate and Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03120468

19422

Details and patient eligibility

About

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).

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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16 participants in 2 patient groups

Topiramate and N-Acetyl Cysteine

Experimental group

Description:

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

Treatment:

Drug: Topiramate and N-Acetyl Cysteine

Topiramate and Placebo

Experimental group

Description:

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

Treatment:

Drug: Topiramate and Placebo