Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-03-03 @ 12:16 AM
Study NCT ID:
NCT03120468
Status:
UNKNOWN
Last Update Posted:
2020-10-27
First Post:
2017-03-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topiramate Augmenting Strategies for the Treatment of Alcohol Use Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077236', 'term': 'Topiramate'}, {'id': 'D000111', 'term': 'Acetylcysteine'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D005632', 'term': 'Fructose'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007661', 'term': 'Ketoses'}, {'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-25', 'studyFirstSubmitDate': '2017-03-31', 'studyFirstSubmitQcDate': '2017-04-14', 'lastUpdatePostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive side effects', 'timeFrame': 'up to13 weeks', 'description': 'Collection of self-report cognitive side effects'}], 'secondaryOutcomes': [{'measure': 'Percent Heavy Drinking Days (PHDD)', 'timeFrame': 'up to 13 weeks', 'description': 'The timeline follow-back (TLFB) method of measuring alcohol consumption will be used for Percent Heavy Drinking Days (PHDD).'}, {'measure': 'Drinks per Drinking Day', 'timeFrame': 'up to 13 weeks', 'description': 'Additional measures of self-reported drinking outcomes'}, {'measure': 'Percentage of Days Abstinent', 'timeFrame': 'up to 13 weeks', 'description': 'Additional measures of self-reported drinking outcomes'}, {'measure': 'Obsessive compulsive drinking scale (OCDS)', 'timeFrame': 'up to 16 weeks', 'description': 'measurement of craving'}, {'measure': 'Drinking Inventory of Consequence (DrInC) scale', 'timeFrame': 'DrInC is at screen, weeks 1,5,9, and 13', 'description': 'measurement of psychosocial consequences of drinking'}, {'measure': 'Clinical Global Improvement (CGI) scale', 'timeFrame': 'up to 16 weeks', 'description': 'Increase in overall clinical improvement'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['alcohol, alcohol dependence, addiction, alcohol use disorder'], 'conditions': ['Alcoholism']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nPrimary 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:\n\n•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).\n\nSecondary 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:\n\n•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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females\n* Ages 18 and above\n* Good physical health\n* Current DSM-V diagnosis of alcohol use disorder\n* 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.\n* Be seeking treatment for problems with alcohol\n* Be able to take oral medication and be willing to adhere to the medication regimen.\n* 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.\n* 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.\n* Not have any unresolved legal problems that could jeopardize continuation or completion of the study.\n* 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.\n\nExclusion Criteria:\n\nPlease contact site for additional information'}, 'identificationModule': {'nctId': 'NCT03120468', 'briefTitle': 'Topiramate Augmenting Strategies for the Treatment of Alcohol Use Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Topiramate Augmenting Strategies for the Treatment of Alcohol Use Disorder', 'orgStudyIdInfo': {'id': '19422'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topiramate and N-Acetyl Cysteine', 'description': 'Drug: Topiramate and N-Acetyl Cysteine Other Name for Topiramate: Topamax', 'interventionNames': ['Drug: Topiramate and N-Acetyl Cysteine']}, {'type': 'EXPERIMENTAL', 'label': 'Topiramate and Placebo', 'description': 'Drug: Topiramate and Placebo Other Name for Topiramate: Topamax Other Name for Placebo: Sugar Pill', 'interventionNames': ['Drug: Topiramate and Placebo']}], 'interventions': [{'name': 'Topiramate and N-Acetyl Cysteine', 'type': 'DRUG', 'otherNames': ['Topamax'], 'description': 'Topiramate up to 200 mg/day and N-Acetyl Cysteine 600 mg twice a day for 12 weeks', 'armGroupLabels': ['Topiramate and N-Acetyl Cysteine']}, {'name': 'Topiramate and Placebo', 'type': 'DRUG', 'otherNames': ['Topamax; Sugar Pill'], 'description': 'Topiramate up to 200 mg/day and Placebo for 12 weeks', 'armGroupLabels': ['Topiramate and Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'UVA Center for Leading Edge Addiction Research', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Nassima Ait-Daoud Tiouririne, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nassima Ait-Daoud Tiouririne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Director of UVA Center for Leading Edge Addiction Research', 'investigatorFullName': 'Nassima Ait-Daoud Tiouririne', 'investigatorAffiliation': 'University of Virginia'}}}}