AlcoholismEarly Phase 1NCT03120468
Topiramate Augmenting Strategies for the Treatment of Alcohol Use Disorder
A Early Phase 1 study testing Topiramate and N-Acetyl Cysteine in people with Alcoholism, run by Nassima Ait-Daoud Tiouririne at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholism
- What is being tested?
- Topiramate and N-Acetyl Cysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 30 Jun 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- Please contact site for additional information
Trial locations and contacts
1 site in 1 country.
United States1 site
UVA Center for Leading Edge Addiction Research
Charlottesville, Virginia, 22903
About this study
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).
Read the 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
- Being tested
- Topiramate and N-Acetyl Cysteine, Topiramate and Placebo
- Keywords
- alcohol, alcohol dependence, addiction, alcohol use disorder
- Medical subject headings
- Alcoholism, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topiramate and N-Acetyl CysteineDrug
Also called Topamax
Topiramate up to 200 mg/day and N-Acetyl Cysteine 600 mg twice a day for 12 weeks
Topiramate and PlaceboDrug
Also called Topamax; Sugar Pill
Topiramate up to 200 mg/day and Placebo for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Topiramate and N-Acetyl Cysteine | Experimental | Drug: Topiramate and N-Acetyl Cysteine Other Name for Topiramate: Topamax Receives: Drug: Topiramate and N-Acetyl Cysteine |
| Topiramate and Placebo | Experimental | Drug: Topiramate and Placebo Other Name for Topiramate: Topamax Other Name for Placebo: Sugar Pill Receives: Drug: Topiramate and Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive side effects
Collection of self-report cognitive side effects
Measured: up to13 weeks
Secondary outcomes (6)
Percent Heavy Drinking Days (PHDD)
The timeline follow-back (TLFB) method of measuring alcohol consumption will be used for Percent Heavy Drinking Days (PHDD).
Measured: up to 13 weeks
Drinks per Drinking Day
Additional measures of self-reported drinking outcomes
Measured: up to 13 weeks
Percentage of Days Abstinent
Additional measures of self-reported drinking outcomes
Measured: up to 13 weeks
Obsessive compulsive drinking scale (OCDS)
measurement of craving
Measured: up to 16 weeks
Drinking Inventory of Consequence (DrInC) scale
measurement of psychosocial consequences of drinking
Measured: DrInC is at screen, weeks 1,5,9, and 13
Clinical Global Improvement (CGI) scale
Increase in overall clinical improvement
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start1 May 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nassima Ait-Daoud Tiouririne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nassima Ait-Daoud Tiouririne, University of Virginia
- Investigators
- Nassima Ait-Daoud Tiouririne, M.D., Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120468
- Sponsor's protocol ID
- 19422
- Status last verified
- May 2026
- First submitted
- 31 Mar 2017
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topiramate Augmenting Strategies for the Treatment of Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT03120468
- Acronym / sponsor ID
- 19422
- Conditions
- Alcoholism
- Keywords
- alcohol, alcohol dependence, addiction, alcohol use disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Nassima Ait-Daoud TiouririneUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 19 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topiramate and N-Acetyl Cysteine | Experimental | Drug: Topiramate and N-Acetyl CysteineDrug: Topiramate and N-Acetyl Cysteine Other Name for Topiramate: Topamax |
| Topiramate and Placebo | Experimental | Drug: Topiramate and PlaceboDrug: Topiramate and Placebo Other Name for Topiramate: Topamax Other Name for Placebo: Sugar Pill |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (1 listed)
- Please contact site for additional information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topiramate and N-Acetyl CysteineAlso: TopamaxTopiramate up to 200 mg/day and N-Acetyl Cysteine 600 mg twice a day for 12 weeks | Drug | Topiramate and N-Acetyl Cysteine |
| Topiramate and PlaceboAlso: Topamax; Sugar PillTopiramate up to 200 mg/day and Placebo for 12 weeks | Drug | Topiramate and Placebo |
Primary outcome
Cognitive side effects
Time frame: up to13 weeks
Collection of self-report cognitive side effects
6 secondary outcomes
Percent Heavy Drinking Days (PHDD)
Time frame: up to 13 weeks
Drinks per Drinking Day
Time frame: up to 13 weeks
Percentage of Days Abstinent
Time frame: up to 13 weeks
Obsessive compulsive drinking scale (OCDS)
Time frame: up to 16 weeks
Drinking Inventory of Consequence (DrInC) scale
Time frame: DrInC is at screen, weeks 1,5,9, and 13
Clinical Global Improvement (CGI) scale
Time frame: up to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nassima Ait-Daoud Tiouririne, M.D. principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Topiramate and N-Acetyl Cysteine in people with Alcoholism, run by Nassima Ait-Daoud Tiouririne at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive side effects (time frame: up to13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.