Zonisamide Outpatient Study

Status Withdrawn

Clinical Trial Summary

The objective of this study is to determine if, compared to placebo, zonisamide (400mg/day) is a safe and efficacious treatment for post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD) in Veterans with PTSD and co-occurring AUD.

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled study to examine the ability of 5-weeks treatment with zonisamide to reduce symptoms of PTSD and AUD. The study population will consist of 60 Veterans with combat-related PTSD and co-morbid AUD. Veterans will be randomized 1:1 to receive either zonisamide (up to 400 mg/day) or placebo daily for 35±4days, followed by a 14-day down-titration period with follow-up. Primary efficacy variables are scores on the CAPS-5, fear-potentiated startle (FPS) responses, and percent of heavy drinking days (%HDD). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03376139
Study type	Interventional
Source	Pharmacotherapies for Alcohol and Substance Abuse Consortium
Contact
Status	Withdrawn
Phase	Phase 2
Start date	March 1, 2019
Completion date	August 31, 2019

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04788004` - Long-term Recovery: Longitudinal Study of Neuro-behavioral Markers of Recovery and Precipitants of Relapse
Recruiting	`NCT05684094` - Mechanisms of Risky Alcohol Use in Young Adults: Linking Sleep to Reward- and Stress-Related Brain Function	N/A
Completed	`NCT03406039` - Testing the Efficacy of an Online Integrated Treatment for Comorbid Alcohol Misuse and Emotional Problems	N/A
Completed	`NCT03573167` - Mobile Phone-Based Motivational Interviewing in Kenya	N/A
Completed	`NCT04817410` - ED Initiated Oral Naltrexone for AUD	Phase 1
Active, not recruiting	`NCT04267692` - Harm Reduction Talking Circles for American Indians and Alaska Natives With Alcohol Use Disorders	N/A
Completed	`NCT03872128` - The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders	Phase 1
Recruiting	`NCT06030154` - Amplification of Positivity for Alcohol Use	N/A
Active, not recruiting	`NCT05419128` - Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19	N/A
Completed	`NCT04564807` - Testing an Online Insomnia Intervention	N/A
Completed	`NCT04284813` - Families With Substance Use and Psychosis: A Pilot Study	N/A
Completed	`NCT04203966` - Mental Health and Well-being of People Who Seek Help From Their Member of Parliament
Recruiting	`NCT05861843` - Craving Assessment in Patients With Alcohol Use Disorder Using Virtual Reality Exposure
Terminated	`NCT04404712` - FAAH Availability in Psychiatric Disorders: A PET Study	Early Phase 1
Enrolling by invitation	`NCT04128761` - Decreasing the Temporal Window in Individuals With Alcohol Use Disorder	N/A
Not yet recruiting	`NCT06163651` - Evaluating a One-Year Version of the Parent-Child Assistance Program	N/A
Not yet recruiting	`NCT06337721` - Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults	N/A
Enrolling by invitation	`NCT02544581` - Preliminary Analysis of the Soberlink Alcohol Breath Analyzer System's (SABA) Clinical Utility During Aftercare	N/A
Completed	`NCT02511886` - A Dose-Escalation Study to Determine the Maximum Tolerated Dose of Arbaclofen Placarbil in Subjects With Alcohol Use Disorder	Phase 2
Active, not recruiting	`NCT02185131` - Double-blind Pilot Trial of Mirtazapine for the Treatment of Co-occurring AD/MDD.	Phase 2