NCT03120468

Topiramate Augmenting Strategies for the Treatment of Alcohol Use Disorder

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Nassima Ait-Daoud Tiouririne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Alcoholism

Interventions

Type	Name	Description
DRUG	Topiramate and N-Acetyl Cysteine	Topiramate up to 200 mg/day and N-Acetyl Cysteine 600 mg twice a day for 12 weeks
DRUG	Topiramate and Placebo	Topiramate up to 200 mg/day and Placebo for 12 weeks

Timeline

• Start date: 2017-05-01
• Primary completion: 2021-01-01
• Completion: 2021-01-01
• First posted: 2017-04-19
• Last updated: 2020-10-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study