Topiramate Augmenting Strategies for the Treatment of Alcohol Use Disorder

Alcoholism Clinical Trial

Official title:

Topiramate Augmenting Strategies for the Treatment of Alcohol Use Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03120468
• Other study ID #: 19422
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: May 1, 2017
• Est. completion date: January 2021

Study information

• Verified date: October 2020
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcoholism

Intervention

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

Locations

Country	Name	City	State
United States	UVA Center for Leading Edge Addiction Research	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Nassima Ait-Daoud Tiouririne

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive side effects	Collection of self-report cognitive side effects	up to13 weeks
Secondary	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
Secondary	Drinks per Drinking Day	Additional measures of self-reported drinking outcomes	up to 13 weeks
Secondary	Percentage of Days Abstinent	Additional measures of self-reported drinking outcomes	up to 13 weeks
Secondary	Obsessive compulsive drinking scale (OCDS)	measurement of craving	up to 16 weeks
Secondary	Drinking Inventory of Consequence (DrInC) scale	measurement of psychosocial consequences of drinking	DrInC is at screen, weeks 1,5,9, and 13
Secondary	Clinical Global Improvement (CGI) scale	Increase in overall clinical improvement	up to 16 weeks