Assessment of Potential Interactions Between GBR 12909 and Cocaine - 1
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2005 by National Institute on Drug Abuse (NIDA).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00100113
First received: December 22, 2004
Last updated: October 23, 2007
Last verified: March 2005
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 22, 2004 | ||||
| Last Updated Date | October 23, 2007 | ||||
| Start Date ICMJE | June 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Heart rate | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00100113 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 | Assessment of Potential Interactions Between GBR 12909 and Cocaine - 1 | ||||
| Official Title ICMJE | Study of Interactions Between GBR 12909 and Cocaine | ||||
| Brief Summary | The purpose of this study is to assess potential interactions between intravenous (IV) cocaine and 3 doses of GBR 12909. |
||||
| Detailed Description | This is Phase 1, double-blind, placebo-controlled human laboratory clinical pharmacology study that will assess the potential interactions between IV cocaine and 3 escalating oral doses of GBR 12909. The primary objective is to determine safety of GBR 12909 administration and if there are significant interactions between GBR 12909 treatment concurrent with IV cocaine infusions. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Primary Purpose: Treatment | ||||
| Condition ICMJE | Cocaine-Related Disorders | ||||
| Intervention ICMJE | Drug: GBR 12909 | ||||
| Study Arm (s) | 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. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 24 | ||||
| Completion Date | June 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 45 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 | NCT00100113 | ||||
| Other Study ID Numbers ICMJE | NIDA-CPU-0004-1 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | National Institute on Drug Abuse (NIDA) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Institute on Drug Abuse (NIDA) | ||||
| Verification Date | March 2005 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||