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 @ 11:47 PM
Ignite Modification Date:
2025-12-24 @ 11:47 PM
NCT ID:
NCT01843751
Eligibility Criteria:
Inclusion Criteria:
* Enrollment in the Drug Treatment Court
* diagnosis of opioid dependence using the Addiction Severity Index-Lite and diagnosis by clinical staff of referring units
* opioid positive urine drug screen at baseline
* women of childbearing potential who have a negative screening urine pregnancy test and are willing to use reliable birth control methods throughout the duration of the study.
Exclusion Criteria:
* pregnancy
* women who are currently breastfeeding
* complex psychiatric co-morbidity (e.g. suicidality, psychosis)
* complex medical co-morbidity (e.g. major cardiovascular, renal, or gastrointestinal/hepatic disease)
* or current pharmacotherapy with an agent which is contraindicated in combination with buprenorphine/naloxone according to drug labeling (
* Specific medical conditions, to be identified via initial medical history and examination, which would necessitate exclusion from study participation include: paralytic ileus, coronary artery disease or heart arrhythmia, recent head injury, obstructive sleep apnea, severe asthma or COPD, end-stage renal disease, or severe morbid obesity.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT01843751
Study Brief:
Protocol Section:
NCT01843751