Zonisamide Treatment of Alcohol Use Disorder: an Evaluation of Efficacy and Mechanism of Action (Z-Comp)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02900352|
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : August 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use Disorder||Drug: Zonisamide Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Zonisamide Treatment of Alcohol Use Disorder: an Evaluation of Efficacy and Mechanism of Action|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind (Titration of dose to 500mg oral, daily, over 8 weeks, then 7 weeks of treatment at that dose). Subjects may increase their dose to 600mg daily during the target treatment period if it is thought to be beneficial.
Titration of dose to 500mg oral, daily, over 8 weeks, then 7 weeks of treatment at that dose
Placebo Comparator: Placebo
Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group)
- Change in number of drinks per week [ Time Frame: over 8 weeks (weeks 9-16) ]Difference between groups in the number of total standard drinks per week over 8 weeks (weeks 9-16, the weeks on the target dose) performed using a mixed models longitudinal analysis.
- PSNHDD [ Time Frame: over 8 weeks (weeks 9-16) ]percentage of subjects with no heavy drinking days (PSNHDD) The PSNHDD can be derived from each subject's TLFB data.
- Change in Gamma glutamyl transferase (GGT) [ Time Frame: over 16 weeks (weeks 1-16) ]Difference between groups on change in levels of GGT over time from baseline to endpoint, which will include several interim data points. This will analyzed with a mixed models longitudinal analysis (repeated measures).
- Change in number of heavy drinking days per week [ Time Frame: over 16 weeks (weeks 9-16) ]The difference in the number of heavy drinking days per week compared between groups (zonisamide and placebo) during the time spent on the target dose of the medication. Performed using a mixed models longitudinal analysis (repeated measures).
- Change in Alcohol Urge Questionnaire Score (AUQ) [ Time Frame: over 16 weeks (weeks 1-16) ]This is the change in AUQ scores (urge to drink) measured weekly compared between groups using repeated measures
- Change in quality of life [ Time Frame: over 16 weeks (weeks 1-16) ]Change in quality of life scores measured by the Q-LES-Q
- Changes in level of alcohol-related problems [ Time Frame: over 16 weeks (weeks 1-16) ]Change in level of alcohol-related problems measured by the Short Index of Problems (SIP)
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): NCT02900352
|Contact: Albert Arias, MD||203-932-5711 ext firstname.lastname@example.org|
|United States, Connecticut|
|UCONN Health||Active, not recruiting|
|Farmington, Connecticut, United States, 06030|
|New Haven, Connecticut, United States, 06520|
|West Haven Veterans Affairs||Active, not recruiting|
|West Haven, Connecticut, United States, 06515|
|United States, Virginia|
|Virginia Commonwealth University||Recruiting|
|Richmond, Virginia, United States, 23298|
|Contact: Albert Arias, MD email@example.com|
|Principal Investigator:||Albert Arias, MD||Virginia Commonwealth University|