Cognitive Function and Pain Threshold in People Who Are Methadone Maintained

NCT04027166 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: MS057
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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

Pain

Outcome Measures

Primary Outcomes (1)

• changes in cognitive functioning using the go no go task

  during methadone peak and trough states.

  up to 24 months

Secondary Outcomes (1)

• self-reported measures of pain from the cold pressor test

  up to 24 months

Study Arms (2)

administration immediate

EXPERIMENTAL

Methadone will be administered prior to study procedures

Drug: Methadone

administration delayed

EXPERIMENTAL

Methadone will be held for four hours until the end of all study procedures.

Drug: Methadone

Interventions

Methadone DRUG

Methadone will be administered before study procedures

administration immediate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Veteran Affairs Hospital

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Methadone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• Mehmet Sofuoglu, M.D., Ph.D.

  Veteran Affairs Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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 hours 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.

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 19, 2019
• Study Start: July 1, 2019
• Primary Completion: March 10, 2021
• Study Completion: April 28, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)