Infusion Laboratory: Protocol 3 (Risperidone) - 4
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ClinicalTrials.gov Identifier: NCT00000339 |
Recruitment Status
: Unknown
Verified June 1996 by National Institute on Drug Abuse (NIDA).
Recruitment status was: Active, not recruiting
First Posted
: September 21, 1999
Last Update Posted
: January 11, 2017
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Sponsor:
National Institute on Drug Abuse (NIDA)
Information provided by:
National Institute on Drug Abuse (NIDA)
Tracking Information | ||||
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First Submitted Date ICMJE | September 20, 1999 | |||
First Posted Date ICMJE | September 21, 1999 | |||
Last Update Posted Date | January 11, 2017 | |||
Study Start Date ICMJE | June 1996 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00000339 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Infusion Laboratory: Protocol 3 (Risperidone) - 4 | |||
Official Title ICMJE | Infusion Laboratory: Protocol 3 (Risperidone) | |||
Brief Summary | The purpose of this study is to evaluate clinical safety issues pertaining to risperidone, to cocaine and to its interaction, and to determine how pretreatment with risperidone modifies the subjective as well as physiological effects of cocaine. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Intervention Model: Crossover Assignment Masking: Single Primary Purpose: Treatment |
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Condition ICMJE | Cocaine-Related Disorders | |||
Intervention ICMJE | Drug: Risperidone | |||
Study Arms | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Enrollment ICMJE |
13 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date | Not Provided | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria: M/F ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe. |
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Sex/Gender |
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Ages | 21 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00000339 | |||
Other Study ID Numbers ICMJE | NIDA-3-0010-4 Y01-3-0010-4 |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | National Institute on Drug Abuse (NIDA) | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | National Institute on Drug Abuse (NIDA) | |||
Verification Date | June 1996 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |