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 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 1:28 AM
NCT ID:
NCT04308694
Eligibility Criteria:
Inclusion Criteria:
* Patient aged 18 or older receiving methadone treatment at Morse Clinic in Raleigh or Zebulon, NC.
* Able to provide informed written consent to participate in the pilot study.
* Receiving a stable methadone dose between 5 mg and 160 mg.
* Having all negative drug tests (except for prescribed methadone and ethanol) at the OTP for the past 12 months.
* No missed call-backs in the past 12 months.
* No signs/symptoms of a co-occurring major mental illness (i.e., thought disorder, thoughts of harm to self or others, delusions or hallucinations, cognitive impairment compromising informed consent to study procedures and requirements).
* Meeting the federal and state regulations for eligibility to receive between 6- and 13-days of take-home methadone and receiving this level of take-home doses at the time of study enrollment.
* If female, using adequate birth control methods.
Exclusion Criteria:
* Have a serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make study participation hazardous to the participant, compromise study findings, or prevent the participant from completing the study.
* Have chronic pain requiring ongoing pain management with opioid analgesics.
* Prisoner status or pending legal action that could prevent participation in study activities
* Legal order for treatment (e.g., parole, probation, or pre-trial)
* Pregnant or breastfeeding at the time of screening.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04308694
Study Brief:
Protocol Section:
NCT04308694