Phase 2
N=19
Effect of Zonisamide on Cocaine Reinforcement, Craving, and Relapse
Cocaine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01137890 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Change in Visual Analog Questionnaire (VAQ) Score — 0.38; 3.75; 0.38; 40.63 units on a scale — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Zonisamide (Drug); Placebo (Drug); Cocaine Hydrochloride (Drug); Neurocognitive and Performance Battery (Behavioral); Smoking Assessments (Behavioral)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Visual Analog Questionnaire (VAQ) Score |
0.38; 3.75; 0.38; 40.63; 32.63; 30.00 | <0.01 sig |
| PRIMARY Behavioral Choice Measures |
0; 0; 0.25; 2; 2.38; 2.25 | <0.01 sig |
| PRIMARY Cocaine Craving |
27.88; 27.25; 25; 19.13; 17.88; 13.5 | 0.16 |
| SECONDARY Drug Value Questionnaire |
0; 0; 0; 9.29; 8.50; 7.63 | <0.01 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Age at least 21 years old, not older than 45 years.
- Evidence of cocaine dependence.
- Not seeking treatment for cocaine abuse.
- Able and willing to be restricted to our unit for 6-7 weeks.
- Able to answer frequent questionnaires reliably and consistently.
- Smoker.
Exclusion Criteria
- Allergy to Sulfonamide drugs (e.g. topiramate, zonisamide, sulfamethoxazole/trimethoprim).
- Diabetes, respiratory insufficiency, renal tubular acidosis or renal insufficiency, heart failure, liver insufficiency, chronic diarrhea, other chronic diseases predisposing to acidosis.
- Renal insufficiency defined as serum creatine > 1.30 mg/DL for males or > 1.03 mg/DL for females.
- History of nephrolithiasis, unexplained hematuria on screening urinalysis.
- History of head injury (with loss of consciousness longer than a few minutes).
- History of seizure, or use of antiepileptic medications.
- HIV positive individuals who meet AIDS by Centers for Disease Control (CDC) criteria or are on antiretroviral medications.
- BMI 34.
- Total cholesterol > 240mg%.
- Serous psychiatric illness with psychosis, dementia.
- Glaucoma, family history of glaucoma, one-sided blindness.
- For female participants: being pregnant, lactating or not using an effective method of contraception.
- Physical dependence on any drug other than cocaine, nicotine, or caffeine.
Data sourced from ClinicalTrials.gov (NCT01137890). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.