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NCT03973489 · ClinicalTrials.gov registry record · Phase 4
Effects of Genotype on Resting State Connectivity During Methamphetamine Administration
A Phase 4 study, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- Phase 4
- Development phase
- 69
- Enrollment target
NCT03973489: Completed Phase 4 study, sponsored by Oregon Health and Science University.
NCT03973489 is a Phase 4 study that has completed, run by Oregon Health and Science University. The registered enrollment target is 69 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03973489, a Phase 4 study, has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 69 participants
- Enrollment target
Study Summary
Addiction to methamphetamine (MA) is a serious health problem in the United States. Right now, there are no medically approved treatments for MA dependence. More research is needed to understand how MA affects the brain and to eventually develop medical interventions for MA addiction. The purpose of the study is to learn more about how MA use affects the brain by investigating a receptor in the brain called trace amine-associated receptor 1 (TAAR1). The investigators are hoping to find out if individuals with certain versions of the brain receptor react differently when given MA. The TAAR1 receptor has two prevalent genetic variations due to a single nucleotide polymorphism. These are the wild type (WT) and a common variant (CV). Preliminary studies have shown that these variants produce different connectivity (resting state functional connectivity or RSFC) in the brains of individuals with MA use disorder (MUD), specifically that individuals with the CV genotype exhibit lower RSFC than WT. In this study, MA will be administered to individuals with MA use disorder and healthy controls in order to: 1. Determine the influence of CV vs. WT genotype on RSFC and craving in individuals with chronic MUD and healthy controls. 2. Determine the effect of acute methamphetamine or placebo administration on the interaction of CV vs WT genotype on RSFC, craving, cognitive control, attention and subjective experience in MUD and healthy controls.
Primary Outcome
Pearson correlation coefficient (r) was used to calculate cortico-striatal and intra-striatal functional connectivity during resting state. These r values were then converted into Fisher's Z-scores using the transformation: z = arctanh(r) = 0.5\*ln((1+r)/(1-r)). Fisher's Z-transformation linearizes Pearson correlations and allows for statistical analysis. The Z-scores represent the strength and direction of functional connectivity between brain regions. A Z-score of 0 represents the population m
Interventions
- DRUG Placebo oral tablet
- BEHAVIORAL Magnetic resonance imaging (MRI)
- DRUG Methamphetamine Hydrochloride Tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2019-08-16 |
| Est. Completion | 2023-03-31 |
| Phase | Phase 4 |
What the finished NCT03973489 record still lists
NCT03973489 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo oral tablet is the first listed.
NCT03973489 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03973489 about?
NCT03973489 is a clinical study titled "Effects of Genotype on Resting State Connectivity During Methamphetamine Administration". Addiction to methamphetamine (MA) is a serious health problem in the United States. Right now, there are no medically approved treatments for MA dependence. More research is needed to understand how MA affects the brain and to eventually develop medical interventions for MA addiction. The purpose of...
What is the current status of trial NCT03973489?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 69 participants. The study started on 2019-08-16. Estimated completion is 2023-03-31.
What interventions are being tested in trial NCT03973489?
The interventions under investigation include: Placebo oral tablet (DRUG), Magnetic resonance imaging (MRI) (BEHAVIORAL), Methamphetamine Hydrochloride Tablets (DRUG).
Who is sponsoring clinical trial NCT03973489?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03973489's enrollment target sits among peer trials
69 1070th of 2000 higher than 925 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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