Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT04473950
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04473950
Study Brief:
Protocol Section:
NCT04473950