Study of the Effects of Risperdal Consta on Brain Reward Circuitry Function, Craving and Cocaine Use in Active Cocaine Dependence
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Massachusetts General Hospital.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Massachusetts General Hospital
Collaborator:
Janssen, LP
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00385801
First received: October 6, 2006
Last updated: May 3, 2010
Last verified: May 2010
| Tracking Information | |||||
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| First Received Date ICMJE | October 6, 2006 | ||||
| Last Updated Date | May 3, 2010 | ||||
| Start Date ICMJE | September 2005 | ||||
| Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
functional MRI activation patterns in the nucleus accumbens and amygdala in response to cocaine cues | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00385801 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of the Effects of Risperdal Consta on Brain Reward Circuitry Function, Craving and Cocaine Use in Active Cocaine Dependence | ||||
| Official Title ICMJE | A Double-Blind, Placebo-Controlled Study of the Effects of Risperdal Consta on Brain Reward Circuitry, Craving and Cocaine Use in Active Cocaine Dependence | ||||
| Brief Summary | The purpose of this study is to examine the effects of the administration of Risperidal-Consta on the brain's reward circuitry using MRI, behavioral tests and measuring cocaine craving and use among people with active cocaine dependence. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE | Cocaine Dependence | ||||
| Intervention ICMJE | Drug: Risperidal-Consta | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Loebl T, Angarita GA, Pachas GN, Huang KL, Lee SH, Nino J, Logvinenko T, Culhane MA, Evins AE. A randomized, double-blind, placebo-controlled trial of long-acting risperidone in cocaine-dependent men. J Clin Psychiatry. 2008 Mar;69(3):480-6. | ||||
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* 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 | Active, not recruiting | ||||
| Enrollment ICMJE | Not Provided | ||||
| Estimated Completion Date | September 2010 | ||||
| Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00385801 | ||||
| Other Study ID Numbers ICMJE | RIS-EMR-4021 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Tsafrir Loebl, MD, Massachusetts General Hospital | ||||
| Study Sponsor ICMJE | Massachusetts General Hospital | ||||
| Collaborators ICMJE | Janssen, LP | ||||
| Investigators ICMJE |
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| Information Provided By | Massachusetts General Hospital | ||||
| Verification Date | May 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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