Potential participants will complete a telephone and an in-clinic screening to determine eligibility for this study. Eligible participants will be randomized to receive one of two treatment conditions: 1) Zonisamide plus Take Control (a computerized alcohol reduction and medication compliance program developed by the National Institute on Alcohol Abuse and Alcoholism (NIAAA)); 2) a placebo plus Take Control. For both conditions, participants will receive 12 treatment sessions. Participants will receive medication at each session, and they should have two weeks worth of medication on hand at any given time. Participants will take the medication as prescribed at home. The first 11 treatment sessions will include Take Control. The 12 treatment sessions will be followed by two drug dose taper sessions, and a follow up phone interview immediately following the final session.
Participants will also undergo two scans of less than 2 hours duration, one before they begin study sessions and the second near the end of the study (12th study week and before the medication taper). At the in-clinic screening session, participants will receive a "MRI Information for Research Participants" handout that answers some commonly asked questions about MRI and tells participants what they can expect while undergoing an MRI scan. Both scans will be conducted at BU CILSE. Participants will be screened before each scan session for pregnancy (urine sample, women of childbearing potential only), recent smoking or alcohol use (breathalyzers), and illicit substance use (urine sample). Participants will be asked to complete the Alcohol Urge Questionnaire (AUQ) before and after the scan. Eligible participants will complete a 1-hour 3 Tesla MRI scan involving structural imaging (MRI) and functional imaging (fMRI). The fMRI scans include a resting-state scan (no task involved) a cognitive (Stroop) task, and an alcohol cue reactivity task. The latter two scans involve presentation of visual images to participants while they are in the scanner. No contrast agent or invasive procedures are used. Only personnel trained in working in high magnetic field environments will work on this project. Imaging data will be analyzed on secure networks using only encrypted files. All data obtained will be coded to protect participant privacy and confidentiality.
Starting on March 23, 2020, all study procedures have been moved to HIPAA compliant, remote platforms and can be performed from home due to the COVID-19 pandemic. Screenings will take place over the phone or Zoom, neurocognitive assessments will take place on Inquisit 5 at sessions 1 and 12, female participants of child-bearing potential will be directed to take a pregnancy test at all sessions, and patients will use a breathalyzer provided by Boston University at the start of each session to show they are within study-specified limits of blood alcohol content.
One month following completion of study treatment (study week 16), participants will be asked to complete a follow-up telephone assessment.
The entire study is estimated to be completed in five years. The first six months to nine months of the project will be dedicated to hiring, training and certifying staff. Recruitment will begin within three months of obtaining IRB approval, during Year 1 of the study. Approximately 3-4 new participants will be recruited per month. We anticipate recruiting a total of 5 participants in Year 1, 25 participants in Years 2 and 3, 30 participants in year 4, and 15 participants in Year 5. The last third of Year 5 will be devoted to completion of data entry and data management procedures, preliminary analyses, and the preparation of manuscripts
