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NCT04027166 · ClinicalTrials.gov registry record · Early Phase 1
Cognitive Function and Pain Threshold in People Who Are Methadone Maintained
A Early Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 27
- Enrollment target
NCT04027166: Completed Early Phase 1 study, sponsored by Yale University.
NCT04027166 is a Early Phase 1 study that has completed, run by Yale University. The registered enrollment target is 27 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04027166, a Early Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
Male and female participants, over the age of 18, with OUD currently receiving methadone will be enrolled. This within-subject study design will assess pain and cognitive performance in individuals with OUD engaged in MMT. Participants will be asked to complete two separate 4-hour sessions that will be spaced approximately 2-15 days apart. The two sessions will differ based on methadone administration to evaluate study variables in methadone peak (immediately after dose) and trough (20-24 hour after last dose) states. The order of these sessions will be counterbalanced across participants. At the beginning of each session, participants will complete a pain sensitivity task at baseline and post-methadone administration to determine pain threshold and tolerance. Participants will then complete computerized cognitive assessments of working memory, set-shifting, attentional bias, and behavioral inhibition. The cognitive assessments will administered across three time-points (0, 90, and 180 minutes). Pain threshold and tolerance will be measured again after 240 minutes. In addition, opioid craving, withdrawal, pain intensity, and emotional valence will be repeatedly assessed during 240 minute session.
Primary Outcome
during methadone peak and trough states.
Interventions
- DRUG Methadone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2019-07-01 |
| Est. Completion | 2021-04-28 |
| Phase | Early Phase 1 |
What the finished NCT04027166 record still lists
NCT04027166 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 1 intervention - of which Methadone is the first listed.
NCT04027166 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04027166 about?
NCT04027166 is a clinical study titled "Cognitive Function and Pain Threshold in People Who Are Methadone Maintained". Male and female participants, over the age of 18, with OUD currently receiving methadone will be enrolled. This within-subject study design will assess pain and cognitive performance in individuals with OUD engaged in MMT. Participants will be asked to complete two separate 4-hour sessions that will...
What is the current status of trial NCT04027166?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 27 participants. The study started on 2019-07-01. Estimated completion is 2021-04-28.
What interventions are being tested in trial NCT04027166?
The interventions under investigation include: Methadone (DRUG).
Who is sponsoring clinical trial NCT04027166?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04027166's enrollment target sits among peer trials
27 963rd of 2000 higher than 1,025 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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