drugset / Trial / NCT03376139
Zonisamide Outpatient Study
Phase 2
Withdrawn
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Baylor College of Medicine · collabCongressionally Directed Medical Research Programs · collabMichael E. DeBakey VA Medical Center · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2019-03-01
- Primary completion
- 2019-08-31
- Completion
- 2019-08-31
Publications
- Background Acheson DT, Geyer MA, Baker DG, Nievergelt CM, Yurgil K, Risbrough VB; MRS-II Team. Conditioned fear and extinction learning performance and its association with psychiatric symptoms in active duty Marines. Psychoneuroendocrinology. 2015 Jan;51:495-505. doi: 10.1016/j.psyneuen.2014.09.030. Epub 2014 Oct 7.
- Background Acheson DT, Feifel D, Kamenski M, Mckinney R, Risbrough VB. Intranasal oxytocin administration prior to exposure therapy for arachnophobia impedes treatment response. Depress Anxiety. 2015 Jun;32(6):400-7. doi: 10.1002/da.22362. Epub 2015 Mar 31.
- Background Acheson D, Feifel D, de Wilde S, McKinney R, Lohr J, Risbrough V. The effect of intranasal oxytocin treatment on conditioned fear extinction and recall in a healthy human sample. Psychopharmacology (Berl). 2013 Sep;229(1):199-208. doi: 10.1007/s00213-013-3099-4. Epub 2013 May 5.
- Background Sullivan JT, Sykora K, Schneiderman J, Naranjo CA, Sellers EM. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict. 1989 Nov;84(11):1353-7. doi: 10.1111/j.1360-0443.1989.tb00737.x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Zonisamide | Other / unclassified | 400 mg | — |