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NCT01030692 · ClinicalTrials.gov registry record · Phase 1
Rivastigmine and Huperzine A as Treatments for Cocaine Dependence
A Phase 1 study of Substance Abuse and Cocaine Dependence, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT01030692: Completed Phase 1 study of Substance Abuse and Cocaine Dependence, sponsored by Baylor College of Medicine.
NCT01030692 is a Phase 1 study of Substance Abuse and Cocaine Dependence that has completed, run by Baylor College of Medicine. The registered enrollment target is 72 participants, below the 5,259-participant average among 58 other Substance Abuse trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01030692, a Phase 1 study of Substance Abuse and Cocaine Dependence, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine the safety and effects of rivastigmine and huperzine A (HupA), potential treatments for cocaine abuse, when used before experimental administration of cocaine, on a number of physical and psychological measures.
Primary Outcome
Before and after each cocaine infusion, physiologic responses will be closely monitored using repeated HR, BP, and ECG readings. To evaluate safety, a DSMB will meet annually and following any serious AE to examine data as well as any new published information on rivastigmine or HupA relevant to the project. The number of AEs (including arrhythmias and ECG changes), changes in BP and HR, changes in cocaine PKs, and changes in mood and psychiatric symptoms (using the BSI, BDI, POMS, and BPRS) wil
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Rivastigmine 3 mg
- DRUG Huperzine A 0.4 mg
- DRUG Rivastigmine 6 mg
- DRUG Huperzine A 0.8 mg
Study Locations (1)
Texas
- Michael E. DeBakey Veterans Affairs Medical Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2009-01 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
What the finished NCT01030692 record still lists
NCT01030692 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 5,259-participant average among 58 other Substance Abuse trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Substance Abuse appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT01030692 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01030692 about?
NCT01030692 is a clinical study titled "Rivastigmine and Huperzine A as Treatments for Cocaine Dependence". The purpose of this study is to determine the safety and effects of rivastigmine and huperzine A (HupA), potential treatments for cocaine abuse, when used before experimental administration of cocaine, on a number of physical and psychological measures.
What is the current status of trial NCT01030692?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2009-01. Estimated completion is 2014-06.
What conditions does trial NCT01030692 study?
This clinical trial studies the following conditions: Substance Abuse, Cocaine Dependence, Cocaine Abuse, Cocaine Addiction.
What interventions are being tested in trial NCT01030692?
The interventions under investigation include: Placebo (DRUG), Rivastigmine 3 mg (DRUG), Huperzine A 0.4 mg (DRUG), Rivastigmine 6 mg (DRUG), Huperzine A 0.8 mg (DRUG).
Who is sponsoring clinical trial NCT01030692?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01030692 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01030692's enrollment target sits among peer trials
72 43rd of 58 higher than 16 of 58 other Substance Abuse trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Substance Abuse trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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