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NCT02058966 · ClinicalTrials.gov registry record · Early Phase 1
Pilot Study of Entacapone for Methamphetamine Abuse
A Early Phase 1 study, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 29
- Enrollment target
NCT02058966: Completed Early Phase 1 study, sponsored by Oregon Health and Science University.
NCT02058966 is a Early Phase 1 study that has completed, run by Oregon Health and Science University. The registered enrollment target is 29 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02058966, a Early Phase 1 study, has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
Addiction to methamphetamine is a serious health problem. There are no medications that a doctor can give someone to help them stop using methamphetamine. Entacapone (Comtan©) is a medication that could help people addicted to methamphetamine. This study will see how entacapone works in healthy people who are given methamphetamine. We think that the study drug will be well tolerated, and that it will prevent some of the effects of methamphetamine that make it so addictive. We also want to see how differences in people's genes may cause differences in the ways the study drug and methamphetamine work for them. The study has six total visits. The first visit is for screening. Tests and procedures will make sure it is safe for subjects to participate. The second visit is a familiarization day. Subjects will receive methamphetamine, but no entacapone. This is done to make sure they can tolerate the drug and recognize its effects before being given a second drug on the same day. Subjects will take surveys and computer tests to see how the medications change mood, thinking, and liking the drug. The final four visits are the actual study days. Subjects will be randomly assigned (like the flip of a coin) to the different ways to get either 1) study medication or placebo (placebo contains no active study medication) and then 2) methamphetamine or placebo. Subjects will be in all four groups during the study, which means that each day a subject will get a different group.
Primary Outcome
Profile of Mood States is a 65 item questionnaire using a Likert rating scale to assess transient, distinct moods. The questionnaire contains 65 words/statements that describe feelings people have. The test requires you to indicate for each word or statement how you have been feeling in the past week including today. A Total Mood Disturbance score is calculated by adding scores for Tension, Depression, Anger, Fatigue and Confusion and then subtracting the Vigour score. The Total Mood Disturbance
Interventions
- DRUG Placebo
- DRUG Methamphetamine
- DRUG Entacapone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2014-06 |
| Est. Completion | 2016-06 |
| Phase | Early Phase 1 |
What the finished NCT02058966 record still lists
NCT02058966 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02058966 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02058966 about?
NCT02058966 is a clinical study titled "Pilot Study of Entacapone for Methamphetamine Abuse". Addiction to methamphetamine is a serious health problem. There are no medications that a doctor can give someone to help them stop using methamphetamine. Entacapone (Comtan©) is a medication that could help people addicted to methamphetamine. This study will see how entacapone works in healthy peo...
What is the current status of trial NCT02058966?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 29 participants. The study started on 2014-06. Estimated completion is 2016-06.
What interventions are being tested in trial NCT02058966?
The interventions under investigation include: Placebo (DRUG), Methamphetamine (DRUG), Entacapone (DRUG).
Who is sponsoring clinical trial NCT02058966?
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 NCT02058966's enrollment target sits among peer trials
29 927th of 2000 higher than 1,064 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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