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Topiramate Augmenting Strategies for the Treatment of Alcohol Use Disorder

Primary Purpose

Alcoholism

Status

Unknown status

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Topiramate and N-Acetyl Cysteine

Topiramate and Placebo

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring alcohol, alcohol dependence, addiction, alcohol use disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

UVA Center for Leading Edge Addiction Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Topiramate and N-Acetyl Cysteine

Topiramate and Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cognitive side effects

Collection of self-report cognitive side effects

Secondary Outcome Measures

Percent Heavy Drinking Days (PHDD)

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

Drinks per Drinking Day

Additional measures of self-reported drinking outcomes

Percentage of Days Abstinent

Additional measures of self-reported drinking outcomes

Obsessive compulsive drinking scale (OCDS)

measurement of craving

Drinking Inventory of Consequence (DrInC) scale

measurement of psychosocial consequences of drinking

Clinical Global Improvement (CGI) scale

Increase in overall clinical improvement

Full Information

NCT ID

NCT03120468

First Posted

March 31, 2017

Last Updated

October 25, 2020

Sponsor

Nassima Ait-Daoud Tiouririne

1. Study Identification

Unique Protocol Identification Number

NCT03120468

Brief Title

Topiramate Augmenting Strategies for the Treatment of Alcohol Use Disorder

Official Title

Topiramate Augmenting Strategies for the Treatment of Alcohol Use Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2017 (Actual)

Primary Completion Date

January 2021 (Anticipated)

Study Completion Date

January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Nassima Ait-Daoud Tiouririne

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcoholism

Keywords

alcohol, alcohol dependence, addiction, alcohol use disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Topiramate and N-Acetyl Cysteine

Arm Type

Experimental

Arm Description

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

Arm Title

Topiramate and Placebo

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Topiramate and N-Acetyl Cysteine

Other Intervention Name(s)

Topamax

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Topiramate and Placebo

Other Intervention Name(s)

Topamax; Sugar Pill

Intervention Description

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

Primary Outcome Measure Information:

Title

Cognitive side effects

Description

Collection of self-report cognitive side effects

Time Frame

up to13 weeks

Secondary Outcome Measure Information:

Title

Percent Heavy Drinking Days (PHDD)

Description

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

Title

Drinks per Drinking Day

Description

Additional measures of self-reported drinking outcomes

Time Frame

up to 13 weeks

Title

Percentage of Days Abstinent

Description

Additional measures of self-reported drinking outcomes

Time Frame

up to 13 weeks

Title

Obsessive compulsive drinking scale (OCDS)

Description

measurement of craving

Time Frame

up to 16 weeks

Title

Drinking Inventory of Consequence (DrInC) scale

Description

measurement of psychosocial consequences of drinking

Time Frame

DrInC is at screen, weeks 1,5,9, and 13

Title

Clinical Global Improvement (CGI) scale

Description

Increase in overall clinical improvement

Time Frame

up to 16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nassima Ait-Daoud Tiouririne, M.D.

Organizational Affiliation

University of Virginia

Official's Role

Principal Investigator

Facility Information:

Facility Name

UVA Center for Leading Edge Addiction Research

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Topiramate Augmenting Strategies for the Treatment of Alcohol Use Disorder

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