Clinical trial NCT03120468: 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
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Alcoholism
Keywords: alcohol, alcohol dependence, addiction, alcohol use disorder
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2017-04-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

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Primary outcomes:
measure: Cognitive side effects
timeFrame: up to13 weeks
Secondary outcomes:
measure: Percent Heavy Drinking Days (PHDD)
timeFrame: up to 13 weeks
measure: Drinks per Drinking Day
timeFrame: up to 13 weeks
measure: Percentage of Days Abstinent
timeFrame: up to 13 weeks
measure: Obsessive compulsive drinking scale (OCDS)
timeFrame: up to 16 weeks
measure: Drinking Inventory of Consequence (DrInC) scale
timeFrame: DrInC is at screen, weeks 1,5,9, and 13
measure: Clinical Global Improvement (CGI) scale
timeFrame: up to 16 weeks
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: UVA Center for Leading Edge Addiction Research
state: Virginia
Study officials:
affiliation: University of Virginia
name: Nassima Ait-Daoud Tiouririne, M.D.
role: PRINCIPAL_INVESTIGATOR
References: