Topiramate and Prolonged Exposure

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) frequently co-occur, and having both disorders is associated with greater psychological and functional impairment than having either disorder alone. The most effective PTSD treatment, prolonged exposure (PE) is sometimes less effective when individuals also have AUD. Anti-relapse medication appears promising to improve the effectiveness of PE to help individuals reduce alcohol use and PTSD symptoms and improve functioning. This study compares PE with and without topiramate, a medication shown to both reduce drinking and PTSD symptoms, with the hypothesis that combined PE and topiramate will be more effective than PE and placebo. The aim of this grant is to improve treatment outcomes for Veterans with AUD and PTSD.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Collaborator: University of California, San Diego
• Treatments: Topiramate

Criteria

Inclusion Criteria:

1. Veterans of the U.S. military and/or Reserve/National Guard members,

2. at least 18 years of age,

3. survivors of a psychological trauma meeting DSM-5 criterion A, and are at least one month post-trauma,

4. have current DSM-5 diagnoses of AUD and PTSD based on semi-structured diagnostic interviews,

5. have at least 20 days of heavy drinking (>= 5 drinks/day for men and >= 4/drinks per day for women) in the last 90 days spent in a non-restricted environment and meet criteria for heavy drinking at least 4 days in the last 30 days prior to screening,

6. are not currently receiving trauma-focused psychotherapy,

7. are literate in English and intend to stay in the San Diego area during the study,

8. are willing to attend psychotherapy, medication, and assessment sessions,

9. trying or planning to try to cut down on or abstain from alcohol,

10. for females of childbearing potential, agree to use an approved form of contraception for the duration of the study, including hormonal contraceptives (e.g., oral contraceptives or implantable devices), intrauterine device (IUD), or double barrier methods (e.g., diaphragm with spermicidal condom); barrier method is preferred as topiramate may make birth control less effective,

11. Individuals with clinically significant renal disease and/or impaired renal function, as defined by clinically significant elevation of blood urea nitrogen (BUN) or creatinine or an estimated creatinine clearance of < 60 mL/min, can be included with physician approval, however the dosing schedule and maximum dose will be adjusted in accordance with FDA prescribing guidelines,

12. if individual is on another addiction medication, they should be on a stable approved addiction medication dose (at least two weeks before starting study drug) throughout the study,

13. are capable of giving informed consent.

Exclusion Criteria:

1. Subjects known to have clinically significant unstable medical or psychiatric conditions, where participation is deemed by investigators and study physicians to be risky, including but not limited to:

• AST and/or ALT >5 times the upper limit of the normal range and/or an increased serum bilirubin >2 times the upper limit of normal.

• Seizure disorders

2. have been treated with Topiramate for any reason in the past and discontinued the drug due to hypersensitivity reaction

3. in the opinion of the investigator, should not be enrolled because of the precautions, warnings, or contraindications listed on the Topiramate package insert, (e.g., certain types of glaucoma),

4. are pregnant, lactating, or plan to become pregnant during the period of participation in the study

5. in the judgment of the investigator, represent a significant risk of suicidal or homicidal behavior