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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 is a Early Phase 1 study that has completed, run by Yale University. The registered enrollment target is 27 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04027166
The ClinicalTrials.gov registry entry for NCT04027166 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Methadone is the first listed.
NCT04027166 reports 0 study locations.
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.
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