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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: Completed Phase 1 study, sponsored by University of California, Los Angeles.
NCT00713479 is a Phase 1 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Systolic blood pressure is evaluated at 15 min intervals under placebo or varenicline in the presence of methamphetamine over 140 minutes post infusion. Data is pooled and the mean and standard deviation are presented.
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 |
What the finished NCT00713479 record still lists
NCT00713479 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Varenicline, then placebo is the first listed.
NCT00713479 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00713479's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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