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Trial record 22 of 123 for:    Recruiting, Not yet recruiting, Available Studies | "Alcoholism"

Topiramate Augmenting Strategies for the Treatment of Alcohol Use Disorder

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ClinicalTrials.gov Identifier: NCT03120468
Recruitment Status : Recruiting
First Posted : April 19, 2017
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):
Nassima Ait-Daoud Tiouririne, University of Virginia

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).

Condition or disease Intervention/treatment Phase
Alcoholism Drug: Topiramate and N-Acetyl Cysteine Drug: Topiramate and Placebo Early Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Topiramate Augmenting Strategies for the Treatment of Alcohol Use Disorder
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018


Arm Intervention/treatment
Experimental: Topiramate and N-Acetyl Cysteine
Drug: Topiramate and N-Acetyl Cysteine Other Name for Topiramate: Topamax
Drug: Topiramate and N-Acetyl Cysteine
Topiramate up to 200 mg/day and N-Acetyl Cysteine 600 mg twice a day for 12 weeks
Other Name: Topamax

Experimental: Topiramate and Placebo
Drug: Topiramate and Placebo Other Name for Topiramate: Topamax Other Name for Placebo: Sugar Pill
Drug: Topiramate and Placebo
Topiramate up to 200 mg/day and Placebo for 12 weeks
Other Name: Topamax; Sugar Pill




Primary Outcome Measures :
  1. Cognitive side effects [ Time Frame: up to13 weeks ]
    Collection of self-report cognitive side effects


Secondary Outcome Measures :
  1. Percent Heavy Drinking Days (PHDD) [ Time Frame: up to 13 weeks ]
    The timeline follow-back (TLFB) method of measuring alcohol consumption will be used for Percent Heavy Drinking Days (PHDD).

  2. Drinks per Drinking Day [ Time Frame: up to 13 weeks ]
    Additional measures of self-reported drinking outcomes

  3. Percentage of Days Abstinent [ Time Frame: up to 13 weeks ]
    Additional measures of self-reported drinking outcomes

  4. Obsessive compulsive drinking scale (OCDS) [ Time Frame: up to 16 weeks ]
    measurement of craving

  5. Drinking Inventory of Consequence (DrInC) scale [ Time Frame: DrInC is at screen, weeks 1,5,9, and 13 ]
    measurement of psychosocial consequences of drinking

  6. Clinical Global Improvement (CGI) scale [ Time Frame: up to 16 weeks ]
    Increase in overall clinical improvement



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03120468


Contacts
Contact: Eva Jenkins-Mendoza (434)243-0562 emj9c@virginia.edu
Contact: Tracie Kostelac (434)243-0563 tlk5d@virginia.edu

Locations
United States, Virginia
UVA Center for Leading Edge Addiction Research Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Eva Jenkins-Mendoza    434-243-0562    emj9c@virginia.edu   
Contact: Tracie Kostelac    (434)243-0563    tlk5d@virginia.edu   
Sponsors and Collaborators
Nassima Ait-Daoud Tiouririne
Investigators
Principal Investigator: Nassima Ait-Daoud Tiouririne, M.D. University of Virginia

Responsible Party: Nassima Ait-Daoud Tiouririne, Associate Professor, Director of UVA Center for Leading Edge Addiction Research, University of Virginia
ClinicalTrials.gov Identifier: NCT03120468     History of Changes
Other Study ID Numbers: 19422
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nassima Ait-Daoud Tiouririne, University of Virginia:
alcohol, alcohol dependence, addiction, alcohol use disorder

Additional relevant MeSH terms:
Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Acetylcysteine
Topiramate
N-monoacetylcystine
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anticonvulsants
Neuroprotective Agents
Protective Agents
Anti-Obesity Agents
Antiviral Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Antidotes