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NCT03059563 · ClinicalTrials.gov registry record · Phase 1
Dopamine D2/D3 Receptor Upregulation by Varenicline in Methamphetamine Users
A Phase 1 study, sponsored by University of California, Los Angeles.
- Terminated
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
NCT03059563: Clinical Trial Phase 1 study, sponsored by University of California, Los Angeles.
NCT03059563 is a Phase 1 study that was terminated before completion, run by University of California, Los Angeles. The registered enrollment target is 62 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03059563, a Phase 1 study, was terminated before completion, sponsored by University of California, Los Angeles.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
Study Summary
While deficits in dopamine D2-type receptor availability have been linked to substance use disorders, higher availability associates with better behavioral treatment outcomes for stimulant dependence and resilience to addiction. Varenicline has been shown to upregulate D2-type receptors in drug-naive rats, and could be a useful therapeutic approach for the treatment of addictive disorders in humans. The purpose of the study is to assess the relationship between varenicline, dopamine signaling (specifically, D2-type receptor availability), functional connectivity within corticostriatal circuitry, genetic markers associated with smoking and methamphetamine abuse, and measures of cognitive performance. The investigators hypothesize that varenicline but not placebo will upregulate (increase) striatal dopamine D2-type receptor availability and improve cognition, and that the change in availability will correlate with the change in cognition. The investigators also hypothesize that varenicline but not placebo treatment will repair dysregulated connectivity between the striatum and prefrontal cortex observed in methamphetamine users, and will correlate with the change in cognition. The study design consists of two positron emission tomography (PET) and functional magnetic resonance imaging (fMRI) scans to measure dopamine D2-type receptor availability and functional connectivity between the prefrontal cortex and striatum, two cognitive testing sessions including a battery of tests assessing working memory, declarative memory, sustained attention, inhibitory control, and reward-based decision making. Following eligibility screening, thirty six methamphetamine users will be enrolled and tested/scanned once prior to initiation of varenicline or placebo treatment and then again after completion of treatment.
Primary Outcome
Dopamine D2-type receptor binding potential in the striatum measured with positron emission tomography scanning measured at baseline prior to varenicline/placebo and after 3 weeks of varenicline/placebo treatment.
Interventions
- OTHER Placebo
- DRUG Varenicline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2018-01-11 |
| Est. Completion | 2023-09-28 |
| Phase | Phase 1 |
Why NCT03059563 stopped before completion
NCT03059563 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03059563 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03059563 about?
NCT03059563 is a clinical study titled "Dopamine D2/D3 Receptor Upregulation by Varenicline in Methamphetamine Users". While deficits in dopamine D2-type receptor availability have been linked to substance use disorders, higher availability associates with better behavioral treatment outcomes for stimulant dependence and resilience to addiction. Varenicline has been shown to upregulate D2-type receptors in drug-naiv...
What is the current status of trial NCT03059563?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2018-01-11. Estimated completion is 2023-09-28.
What interventions are being tested in trial NCT03059563?
The interventions under investigation include: Placebo (OTHER), Varenicline (DRUG).
Who is sponsoring clinical trial NCT03059563?
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 NCT03059563's enrollment target sits among peer trials
62 824th of 2000 higher than 1,173 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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