Topiramate Augmenting Strategies for the Treatment of Alcohol Use Disorder
NCT ID: NCT03120468
Last Updated: 2020-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
16 participants
INTERVENTIONAL
2017-05-01
2021-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Topiramate and N-Acetyl Cysteine
Drug: Topiramate and N-Acetyl Cysteine Other Name for Topiramate: Topamax
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
Drug: Topiramate and Placebo Other Name for Topiramate: Topamax Other Name for Placebo: Sugar Pill
Topiramate and Placebo
Topiramate up to 200 mg/day and Placebo for 12 weeks
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Nassima Ait-Daoud Tiouririne
OTHER
Responsible Party
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Nassima Ait-Daoud Tiouririne
Associate Professor, Director of UVA Center for Leading Edge Addiction Research
Principal Investigators
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Nassima Ait-Daoud Tiouririne, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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UVA Center for Leading Edge Addiction Research
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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19422
Identifier Type: -
Identifier Source: org_study_id