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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01137890 |
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Date of registration:
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03/06/2010 |
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Primary sponsor: |
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Public title:
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Effect of Zonisamide on Cocaine Reinforcement, Craving, and Relapse
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Scientific title:
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Effect of Zonisamide on Cocaine Reinforcement, Craving, and Relapse |
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Date of first enrolment:
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June 2010 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01137890 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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Countries of recruitment
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United States
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Contacts
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Name:
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Jessica Vanderhoff |
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Address:
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Telephone:
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410-550-2799 |
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Email:
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jvande20@jhmi.edu |
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Affiliation:
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Name:
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Sarah Ilk |
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Address:
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Telephone:
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410-550-0159 |
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Email:
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silk1@jhmi.edu |
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Affiliation:
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Name:
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Annie Umbricht, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johns Hopkins University |
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Key inclusion & exclusion criteria
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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 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.
Age minimum:
21 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cocaine Dependence
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Intervention(s)
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Behavioral: Neurocognitive and Performance Battery
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Behavioral: Smoking Assessments
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Drug: Cocaine Hydrochloride
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Drug: Placebo
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Drug: Zonisamide
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Primary Outcome(s)
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Behavioral Choice measures
[Time Frame: self-administration sessions]
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Cocaine selective severity assessment (measure of cocaine craving)
[Time Frame: daily]
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subjective and objective measures of drug effect
[Time Frame: repeated interval during self-administration sessions]
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Secondary Outcome(s)
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Medication side-effects
[Time Frame: daily]
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neurocognitive assessment
[Time Frame: every other week]
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smoking behaviors
[Time Frame: week-end days]
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Secondary ID(s)
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R01DA027065
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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