Effect of Zonisamide on Cocaine Reinforcement, Craving, and Relapse
Summary
This is a residential pilot trial to evaluate the pharmacodynamic interaction between zonisamide and cocaine, with the goal of evaluating zonisamide's potential for the treatment of cocaine dependence.
Timeline
- Start
- 2010-06
- Primary completion
- 2012-03
- Completion
- 2013-08
Outcome
Missed primary endpoint
registry analysis (superiority test); 1mg-0mg vs 1mg-300mg vs 1mg-600mg vs 20mg-0mg vs 20mg-300mg vs 20mg-600mg vs 40mg-0mg vs 40mg-300mg vs 40mg-600mg; p = 0.72; F-value for main effect of Zon dose 0.34; ANOVA NCT01137890 ↗
registry analysis (superiority test); 1mg-0mg vs 1mg-300mg vs 1mg-600mg vs 20mg-0mg vs 20mg-300mg vs 20mg-600mg vs 40mg-0mg vs 40mg-300mg vs 40mg-600mg; p = 0.93; F-value for main effect of Zon dose 0.07; ANOVA NCT01137890 ↗
registry analysis (superiority test); Day 1 vs Day 2 vs Day 3 vs Day 4 vs Day 5 vs Day 6 vs Day 7 vs Day 8 vs Day 9 vs Day 10 vs Day 11 vs Day 12 vs Day 13 vs Day 14 vs Day 15 vs Day 16 vs Day 17 vs Day 18 vs Day 19 vs Day 20 vs Day 21 vs Day 22 vs Day 23 vs Day 24 vs Day 25 vs Day 26 vs Day 27 vs Day 28 vs Day 29 vs Day 30 vs Day 31 vs Day 32 vs Day 33 vs Day 34 vs Day 35 vs Day 36 vs Day 37 vs Day 38 vs Day 39; p = 0.16; t-value for main effect of Group 1.51; t-test, 2 sided; note: Group (Zonisamide vs Placebo) NCT01137890 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cocaine | Small molecule | — | Intravenous |
| Subject | Zonisamide | Other / unclassified | — | — |