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Cognitive Function and Pain Threshold in People Who Are Methadone Maintained

NCT04027166 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2021-07-20

No results posted yet for this 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.

Conditions

Interventions

DRUG

Methadone

Methadone will be administered before study procedures

DRUG

Methadone

Methadone will be delayed (4 hours) until the end of the procedures

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Mehmet Sofuoglu, M.D., Ph.D. · Veteran Affairs Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2021-03-10
Completion
2021-04-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04027166 on ClinicalTrials.gov