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 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT07044466
Eligibility Criteria:
Inclusion Criteria:
* Any sex or gender; any race or ethnicity; aged 18 years or older
* Patient participants must meet DSM-5 diagnostic criteria for current (i.e., past 12 months) OUD (assessed via the Quick Structured Clinical Interview for DSM-5; Quick SCID)
* Patient participants must be on buprenorphine, as prescribed by their provider, for no more than 4 weeks prior to study initiation
* Concurrent substance use disorders (e.g., alcohol, cannabis) for the patient participant are acceptable, provided opioids are the patient participant's primary substance of choice
* If taking psychotropic medications (excluding buprenorphine), maintenance on a stable dose for at least 4 weeks before study initiation; this is because initiation or change of psychotropic medications (e.g., SSRIs) during the study may interfere with interpretation of results
* Patient participants must identify a CSO participant who consents to participation in the study as well
Exclusion Criteria:
* Moderate-to-severe opioid withdrawal as defined by a score of ≥13 on the Clinical Opioid Withdrawal Scale
* Meeting DSM-5 criteria for a history of or current psychotic or bipolar disorders
* Current suicidal or homicidal ideation and intent; participants who present a serious suicide risk are likely to require hospitalization during the study and they will be referred clinically
* CSO participants meeting DSM-5 criteria for opioid use disorder or any other substance use disorder, excepting tobacco use disorder
* Severe interpersonal violence in the past six months between the patient and the CSO, as defined by an adapted version of the Conflict Tactics Scaled Revised (CTS-2)
* Pregnancy for patient participants
* Prisoners, institutional individuals, and children will not be recruited for this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07044466
Study Brief:
Protocol Section:
NCT07044466