Status:
TERMINATED
The Effect of Chronic Pain on Delay Discounting in Methadone Patients
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid-use Disorder
Chronic Pain Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The epidemic of opioid overdose deaths continues to rise, killing more persons in 2017 than HIV/AIDS at the height of that epidemic. Medication assisted treatment, including methadone and buprenorphin...
Detailed Description
This is an outpatient Phase 1 clinical trial investigating the effect of naloxone precipitated withdrawal on delay discounting. Eligible participants will undergo two experimental sessions presented i...
Eligibility Criteria
Inclusion
- Male and female adults aged 18-65
- Stable methadone dose (at least 21 days) verified by contacting participant's opioid treatment program
- Understand and speak English
- Urine toxicology screen negative for drugs of abuse and positive for methadone
- Participants must be without signs of intoxication as evidenced by ability to receive full dose of methadone prior to research activities.
- Presence of chronic pain (\>3 months) for the Pain group and absence of pain for the No Pain group.
Exclusion
- Unstable psychiatric illness as assessed by the Mini International Neuropsychiatric Interview (e.g. active suicidal ideation, psychosis)
- Unstable medical illness as assessed by the study's independent medical monitor (e.g. uncontrolled hypertension, recent myocardial infarction, recent stroke, unstable angina) that may be affected by precipitated withdrawal
- Prescription opioid use besides methadone
- Acute pain process unrelated to chronic pain
- Women who are pregnant or lactating
- Known allergy to naloxone
Key Trial Info
Start Date :
January 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04473950
Start Date
January 8 2020
End Date
October 6 2022
Last Update
March 26 2025
Active Locations (1)
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1
Zuckerberg San Francisco General Hospital
San Francisco, California, United States, 94110