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:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT03063905
Eligibility Criteria:
Inclusion Criteria:
1. between ages of 18-50
2. able to provide a positive urine toxicology test for heroin, morphine and/or methadone (and free of other drugs of abuse) upon treatment admission
3. without known background disease, including chronic or acute pain
4. otherwise in good physical and mental health, or in the care of a physician who is willing to take responsibility for such treatment
5. able to understand the purpose and instructions of the study, and provide informed consent as approved by the Western and Georgetown University Institutional Review Boards
Exclusion Criteria:
1. meet diagnostic criteria for an active substance use disorder other than opioids and nicotine
2. be acutely psychotic, severely depressed, and/or in need of inpatient psychiatric treatment
3. have a neurological (i.e. Raynaud's syndrome or symptomatic cold neuropathy) or psychiatric illness that would affect pain responses
4. have a history of heart disease, stroke, or a pacemaker or uncontrolled high blood pressure. Good cardiovascular health is stipulated to ensure subjects can tolerate the sympathetic nervous system responses associated with the pain induction procedures.
5. have sensory deficits at pain testing site resulting from medical conditions such as diabetes, alcoholic neuropathy, AIDS neuropathy, severe thyroid, and liver or kidney diseases
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03063905
Study Brief:
Protocol Section:
NCT03063905