Cognitive Function and Pain Threshold in People Who Are Methadone Maintained

Pain Clinical Trial

— OUD  

Official title:

Effects of Methadone on Cognitive Function and Pain Threshold

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04027166
• Other study ID #: MS057
• Status: Completed
• Phase: Early Phase 1
• Start date: July 1, 2019
• Est. completion date: April 28, 2021

Study information

• Verified date: July 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

After completion of the phone screen, eligible participants will be brought into the laboratory, given a description of the study, and assessed on inclusion and exclusion criteria by research personnel. Details pertaining to the cognitive measures, pain measures, and methadone manipulation will be discussed and informed consent will be obtained along with a signed release to allow study personnel to monitor opioid maintenance. Information on medical, psychiatric and drug use histories will be collected. Individuals with a history of vascular problems or high blood pressure will be evaluated by the research physician. In addition, laboratory tests collecting information on blood alcohol content and urine toxicology will be conducted. Participants will be deemed ineligible to participate if they are not medically cleared by research clinician. Veterans who have a positive BAC will be rescheduled and the methadone maintenance program's clinical protocol will be implemented.

All sessions will be conducted at the West Haven VA Connecticut Healthcare Campus. Participants will be asked to complete two sessions, approximately 2-15 days apart. Order of peak and trough sessions will be counterbalanced between participants. Each session will last approximately four hours. Prior to each testing session, participants will be asked to refrain from caffeine for at least one hour. They will be served a standardized breakfast (i.e., bagel and cream cheese) and offered one smoke break prior to beginning the experimental session. They will be asked to refrain from smoking until the completion of the study protocol. Methadone administration will be coordinated with methadone maintenance treatment staff to relay information about which condition the participant will complete on a given session. At the start of each session, participants will complete computerized cognitive assessments and self-report questionnaires. The computerized cognitive measures will repeated at hours 0, 1.5, and 3. Several state questionnaires will be administered at hours every 30 minutes. Participants will also complete a pain sensitivity measure (i.e., cold pressor task) to assess baseline threshold and tolerance at hour 0 and hour 4.

This study is complete with 27 enrolled and 20 completers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 28, 2021
• Est. primary completion date: March 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Methadone
Methadone will be administered before study procedures
• Methadone
Methadone will be delayed (4 hours) until the end of the procedures

Locations

Country	Name	City	State
United States	Veteran Affairs Hospital	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in cognitive functioning using the go no go task	during methadone peak and trough states.	up to 24 months
Secondary	self-reported measures of pain from the cold pressor test	during methadone peak and trough states	up to 24 months