Cognitive Function and Pain Threshold in People Who Are Methadone Maintained

Completed · Early Phase 1

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT04027166

Run by

Yale University

People needed

27

Starts

2019-07-01

Expected to finish

2021-04-28

Last updated by the study team

2021-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females, over the age of 18
• Diagnosed with opioid dependence and currently enrolled in methadone maintenance treatment
• Compliant in opioid maintenance treatment and on a stable dose for two weeks or greater
• No current medical problems deemed contraindicated for participation by physician investigator

You may not qualify if…

• History of psychosis as determined by review of EMR.
• Acute suicidal ideation.
• History of medical conditions that the physician investigator deems contraindicated for inclusion in the study (e.g., untreated hypertension)

Where it is running

• Veteran Affairs Hospital — West Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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