Interdisciplinary Study of A Novel Anticonvulsant in Alcoholism
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|ClinicalTrials.gov Identifier: NCT02901041|
Recruitment Status : Recruiting
First Posted : September 15, 2016
Last Update Posted : January 18, 2018
Alcoholism is the third leading cause of preventable death in the US, accounting for 80,000 deaths annually. Almost 18 million US adults have alcohol use disorder (AUD); however, approved medications for the treatment of AUD has shown limited effectiveness.
Zonisamide (ZON), a broad spectrum anticonvulsant, has proven to be more effective than a placebo in reducing alcohol intake in individuals with alcohol dependence. ZON's mechanism of action seems to be quite distinct from currently approved anti-alcoholism medications, which holds promise for treatment of individuals who are not responsive to conventional medications. However, much remains unknown about ZON's therapeutic mechanisms and ZON's efficacy in treating patients with a diagnosis of AUD.
To fill in these gaps, the investigators will conduct a double-blind randomized controlled study that assesses ZON's treatment mechanisms and effectiveness in reducing alcohol consumption in patients with AUD. Participants will be randomized to one of two conditions: 1) treatment with ZON and a computerized psychotherapy platform called Take Control (TC); 2) treatment with a placebo (PLC) and TC. To understand the neurobiology behind ZON's potential therapeutic effects on AUD, fMRI will be used to compare the brain activity of the ZON+TC versus PLC+TC group while participants perform an alcohol and emotional-word Stroop task, as well as an alcohol related cues task.
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Dependence||Drug: Zonisamide Behavioral: Take Control Drug: Placebo (for Zonisamide)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Interdisciplinary Study of Two Novel Anticonvulsants in Alcoholism|
|Actual Study Start Date :||September 21, 2017|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||August 2021|
Experimental: Zonisamide & Computerized Psychotherapy
Zonisamide capsules (with a target maintenance dose of 400 mg daily) and a seven module computerized psychotherapy for alcohol use disorders called Take Control (9 sessions) will be administered over the course of 12 weeks, followed by a two week medication taper.
ZONEGRAN® (zonisamide) is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. A dose of 400 mg daily will be used as the target maintenance dose in this study but dosing will be modified if needed to adjust for subject tolerance of drug dosing.
Other Name: ZonegranBehavioral: Take Control
Take Control is a seven module computer-based intervention which presents evidence-based alcohol education that includes motivational interviewing and cognitive-behavioral skills building. This program is derived from the National Institute on Alcohol Abuse and Alcoholism's (NIAAA's) self-help approach, Rethinking Drinking.
Active Comparator: Placebo & Computerized Psychotherapy
Placebo capsules (for zonisamide) and a seven module computerized psychotherapy for alcohol use disorders called Take Control will be administered over the course of 14 weeks.
Behavioral: Take Control
Take Control is a seven module computer-based intervention which presents evidence-based alcohol education that includes motivational interviewing and cognitive-behavioral skills building. This program is derived from the National Institute on Alcohol Abuse and Alcoholism's (NIAAA's) self-help approach, Rethinking Drinking.Drug: Placebo (for Zonisamide)
Sugar pills manufactured to mimic Zonisamide capsules.
- Alcohol Consumption [ Time Frame: Change from baseline following 12-week treatment ]Drinking measures derived from Time Line Follow Back data will include the percent days drinking, the number of drinks consumed per day, and the percent days heavy drinking. Heavy drinking will be defined as 4 or more drinks per day for women and 5 or more drinks per day for men.
- Risk Task - Risk Taking Behavior [ Time Frame: Change from baseline at conclusion of 12-week treatment ]The Risk Task (Rogers et al., 1999) measures decision-making under risk.
- Cued Go/No-go Task - Impulsivity [ Time Frame: Change from baseline at conclusion of 12-week treatment ]The cued go no-go task (Fillmore, 2003) measures impulse control by the ability to inhibit instigated, "prepotent" responses.
- Balloon Analogue Risk Task - Risk Taking Behavior [ Time Frame: Change from baseline at conclusion of 12-week treatment ]The Balloon Analogue Risk Task (BART) is a computerized measure of risk taking behavior. The BART models real-world risk behavior through the conceptual frame of balancing the potential for reward versus loss.
- Connors Continuous Performance Task - Impulsivity [ Time Frame: Change from baseline at conclusion of 12-week treatment ]
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): NCT02901041
|Contact: Todd Farchione, PhDfirstname.lastname@example.org|
|United States, Massachusetts|
|Center for Anxiety and Related Disorders - Boston University||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: David H Barlow, PhD 627-353-9610|
|Principal Investigator:||David H Barlow, PhD||Boston University|