- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01137890
Effect of Zonisamide on Cocaine Reinforcement, Craving, and Relapse
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21224
- Behavioral Pharmacology Research Unit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 < 19 or 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Zonisamide
Participants administered blind capsules containing either placebo or zonisamide.
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Eight capsules administered daily in split doses at 22:00 and 09:00.
Other Names:
Cocaine Challenge Sessions: Human laboratory sessions with administration of moderate doses of cocaine by the intravenous route under controlled conditions and cardiovascular monitoring.
Other Names:
Participants will complete tests to assess their abilities and performances on a number of tasks given by a computer or other type of equipment.
Participants answer questions about smoking and smoking behaviors are monitored.
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Placebo Comparator: Placebo
Participants administered only placebo capsules containing lactose.
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Cocaine Challenge Sessions: Human laboratory sessions with administration of moderate doses of cocaine by the intravenous route under controlled conditions and cardiovascular monitoring.
Other Names:
Participants will complete tests to assess their abilities and performances on a number of tasks given by a computer or other type of equipment.
Participants answer questions about smoking and smoking behaviors are monitored.
capsules administered in split doses at 22:00 and 09:00.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Visual Analog Questionnaire (VAQ) Score
Time Frame: Weeks 1-5; mean of weeks 1, 3 and 5 reported
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VAQ measures the change in effect after dose administration.
Participants rate 6 items ("Any Drug Effect", "Rush", "Good Effects", "Bad Effects", "Liking", & "Desire for Cocaine") by pointing an arrow along a 100-point line anchored at either end with "none" (0) & "extremely" (100).
Each participant's score is equal to the sum of all 6 ratings, & the mean of all participant's scores is reported across each condition.
The VAQ is only administered to subjects in the zonisamide (Zon) condition (n=8).
Repeated within-subject measures ANOVA performed to observe the main effects of Zon dose (0, 300, & 600mg) & cocaine dose (1, 20, & 40mg), & their interaction.
All 8 subjects who received Zon completed both 300mg & 600mg doses.
Assessments obtained on Week 1 (0mg Zon), Week 3 (300mg Zon), & Week 5 (600mg Zon), in which all 3 cocaine were co-administered at these times.
Cocaine not administered (only Zon) during Weeks 2 & 4, thus no measures taken at these times
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Weeks 1-5; mean of weeks 1, 3 and 5 reported
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Behavioral Choice Measures
Time Frame: Weeks 1-5, mean of weeks 1, 3 and 5 reported
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In each condition of cocaine-zonisamide dose, participants were asked to choose whether they would rather have a repeated cocaine dose (same dose as most recent administration) or cash of varying monetary value. The mean number of cocaine choices across each drug condition are reported. This measure only included participants in the zonisamide (Zon) condition (n=8), with each arm representing variation in co-administration of cocaine-Zon. Repeated within-subject measures ANOVA performed to observe the main effects of zonisamide dose (0, 300, and 600mg) and cocaine dose (1, 20, and 40mg), and their interaction. Only participants who received the active zonisamide medication (n=8) were included in this portion of the analysis. During self-administration sessions are every 15 min over 1hr45min period. Assessment on Weeks 1 (0mg Zon), 3 (300mg Zon), 5 (600mg Zon), in which varying cocaine doses co-administered. Cocaine not administered (only Zon) during Weeks 2 & 4 |
Weeks 1-5, mean of weeks 1, 3 and 5 reported
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Cocaine Craving
Time Frame: Day 1-39
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Cocaine craving measured by Cocaine Selectivity Severity Assessment (CSSA).
The CSSA is a reliable and valid tool to measure cocaine withdrawal severity within a 24 hr period, and has been shown to predict treatment response in a treatment setting.
Participants are asked to rate 18-items on a Likert scale 0-7, with composite scores ranging 0-126 and higher numbers indicative of more severe withdrawal.
Mean scores on CSSA across 39-day time period are reported.
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Day 1-39
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Drug Value Questionnaire
Time Frame: Weeks 1-5; mean of weeks 1, 3 and 5 reported
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Street Value of Sampled Dose. After co-administration of cocaine-zonisamide, participants were asked to hypothetically estimate the value of the drug they received, if they were to purchase it on the street. The mean value (dollars) across all drug conditions is reported here. Repeated within-subject measures ANOVA performed to observe the main effects of zonisamide dose (0, 300, and 600mg) and cocaine dose (0, 20, and 40mg), and their interaction. Only participants who received the active zonisamide medication (n=8) were included in this portion of the analysis. Additionally, all 8 subjects who received zonisamide completed both 300mg and 600mg doses. Within-subject repeated interval during self-administration sessions. Cocaine not administered (only Zon) during Weeks 2 & 4, thus no measures taken at these times |
Weeks 1-5; mean of weeks 1, 3 and 5 reported
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Annie Umbricht, M.D., Johns Hopkins University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Cocaine-Related Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Anticonvulsants
- Anesthetics, Local
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Dopamine Uptake Inhibitors
- Vasoconstrictor Agents
- Zonisamide
- Cocaine
Other Study ID Numbers
- R01DA027065 (U.S. NIH Grant/Contract)
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