Using zonisamide to reduce alcohol use in adults with alcohol use disorder

Zonisamide for the Treatment of Alcohol Use Disorder in the Addiction Neuroclinical Assessment Framework

This study is testing if the medication zonisamide can help adults with alcohol use disorder drink less alcohol over 12 weeks.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 205 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Washington State University (other)
• Locations: 1 site (Spokane, Washington)
• Trial ID: NCT05134857 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial evaluates the effectiveness of zonisamide, a medication, in reducing alcohol consumption among adults diagnosed with alcohol use disorder (AUD). Participants will be randomly assigned to receive either zonisamide or a placebo, alongside standard treatment, over a 12-week period with follow-up for one year. The study aims to measure changes in alcohol use through biochemical verification and self-reports, providing insights into the medication's efficacy and adherence. The findings may help identify new treatment strategies for individuals with AUD.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 who have a DSM-5 diagnosis of alcohol use disorder and have consumed four or more standard drinks on four or more occasions in the past 30 days.

Not a fit: Patients with a significant risk of dangerous alcohol withdrawal or those currently receiving pharmacotherapy for alcohol may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new pharmacological option for individuals struggling with alcohol use disorder.

How similar studies have performed: Previous studies have explored pharmacotherapies for alcohol use disorder, but the specific use of zonisamide in this context is novel.

Eligibility criteria

Inclusion Criteria:

1. Four or more standard drinks on four or more occasions in the prior 30 days.
2. Seeking AUD treatment.
3. Aged 18-65 years.
4. DSM-5 diagnosis of AUD.
5. Ability to read and speak English.
6. Ability to provide written informed consent.
7. Breath alcohol of 0.00 during informed consent.
8. Provision of at least 1 EtG-positive urine test at any time during the induction period.
9. Non-lactating women of childbearing age using reliable form of birth control with a negative urine pregnancy test at baseline, and
10. Attended at least 4 of 6 visits during the induction period.

Exclusion Criteria:

1. Significant risk of dangerous alcohol withdrawal, defined as a history of alcohol detoxification or seizure in the last 12 months and expression of concern by the participant about dangerous withdrawal;
2. Currently receiving any pharmacotherapy for alcohol or in the past 30 days.
3. Current DSM-5 diagnosis of severe substance use disorder other than nicotine.
4. Suicide attempt in the last 20 years.
5. History of hypersensitivity to sulfonamide medication, Stevens-Johnson Syndrome, penicillin allergy or allergic reaction to any drug
6. Systemic autoimmune disease.
7. History of current seizure disorder (e.g., are they receiving medication currently for their seizures, have they ever been told by their provider that they have epilepsy, or do they have a history of recurring seizures in the last 5 years?).
8. Current clinically significant blood dyscrasia.
9. History of clinically significant renal calculi or renal failure; renal compromise (defined by an elevation of serum creatinine above our laboratory's limit of normal).
10. History of traumatic brain injury (TBI; e.g., ever been told by a provider that they had a moderate or severe TBI, lost consciousness for 30 minutes or longer or had a post-traumatic amnesia lasting a day or longer).
11. Any other current, clinically significant physical disease \[i.e., neurologic, renal, rheumatologic, gastrointestinal, hematologic, pulmonary, endocrine, cardiovascular, hepatic, or autoimmune disease\] on the basis of medical history, physical examination, or routine laboratory evaluation that, in the context of the study would represent a risk to the subject, or significant laboratory abnormalities related to hepatic function such as marked elevations of hepatic aminotransferase levels (i.e., AST and ALT) or direct bilirubin, and
12. Any other medical or psychiatric condition that Dr. Rodin determines would compromise safe participation.

Where this trial is running

Spokane, Washington

• Washington State University — Spokane, Washington, United States (RECRUITING)

Study contacts

• Study coordinator: Abigail L Bowen, MS

Conditions: Alcohol Use Disorder, Zonisamide, Contingency Management, Incentives for Sobriety