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NCT00713479 · ClinicalTrials.gov registry record · Phase 1
An Assessment of the Safety of Varenicline in Methamphetamine-dependent Volunteers
A Phase 1 study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT00713479 is a Phase 1 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 8 participants.
The verdict
NCT00713479, a Phase 1 study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
More people worldwide use amphetamine-type stimulants than any illicit drug besides cannabis, and methamphetamine (MA) abuse and dependence is the fastest growing drug problem in the United States. Much work remains in identifying an effective pharmacotherapy for MA dependence. The neurobiological actions produced by MA involve dopamine (DA), serotonin, and norepinephrine, but also include alterations to cholinergic neurotransmitter systems. Candidate compounds that target acetylcholine (ACh) are attractive options for development that have not received adequate attention. Varenicline is a drug that increases the release of DA in the brain and it is logical to assume that it would to some extent compensate for the reduction in these neurotransmitters that occurs in MA withdrawal. Current research has linked certain genes that are related to neurotransmitters with drug abuse and memory impairment (e.g., A1 allele for the D2 dopamine receptor and catechol-O-methyltransferase). We will take blood samples and test for these genes in order to relate the findings to brain function. This is a double-blind, placebo-controlled, within-subjects study to determine the safety and tolerability of MA in MA-dependent volunteers treated with varenicline and placebo.
Interventions
- DRUG Varenicline, then placebo
- DRUG Placebo, then varenicline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2008-07 |
| Est. Completion | 2009-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00713479
The ClinicalTrials.gov registry entry for NCT00713479 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Varenicline, then placebo is the first listed.
NCT00713479 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00713479 about?
NCT00713479 is a clinical study titled "An Assessment of the Safety of Varenicline in Methamphetamine-dependent Volunteers". More people worldwide use amphetamine-type stimulants than any illicit drug besides cannabis, and methamphetamine (MA) abuse and dependence is the fastest growing drug problem in the United States. Much work remains in identifying an effective pharmacotherapy for MA dependence. The neurobiological a...
What is the current status of trial NCT00713479?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2008-07. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00713479?
The interventions under investigation include: Varenicline, then placebo (DRUG), Placebo, then varenicline (DRUG).
Who is sponsoring clinical trial NCT00713479?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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