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 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT00270257
Eligibility Criteria:
Inclusion Criteria:
* HIV-uninfected within 28 days of enrollment
* Meets DSM-IV criteria for opiate dependence
* Positive urine test for opiates
* Injected opiates at least 12 times in the 28 days prior to enrollment, according to self-report
* Willing to use acceptable forms of contraception for the first 12 months of the study
* Able to provide contact information and willing to be contacted by study staff as necessary
* Available for study visits for at least 2 years
Exclusion Criteria:
* Current treatment with methadone, morphine, levo-alpha-acetyl-methadol (LAAM), naltrexone, or nalmefene
* Currently enrolled in another HIV prevention or drug use intervention study
* Known sensitivity to buprenorphine or naloxone
* Requires immediate medical attention for dependence on alcohol, benzodiazepines, or other substances. People who are dependent on tobacco are not excluded.
* Currently injecting drugs of abuse other than opiates, more than twice in the last 28 days, according to self-report
* Psychological disturbance or cognitive impairment that may interfere with the study
* Acute or chronic kidney failure
* Certain abnormal laboratory values
* Any other medical or psychiatric condition that, in the opinion of the investigator, would make participation in this study unsafe
* Pregnant or breastfeeding
Inclusion Criteria for Substudy:
* Current or former participant in HPTN 058 study in Xinjiang who was actively in the long-term treatment arm on stable maintenance dose of Suboxone when detained/arrested (last dose within 2 days of incarceration), resulting in immediate cessation of Suboxone without tapering
* Currently released from detention
* Willing to complete one-time questionnaire
* Willing to sign informed consent
Exclusion Criteria for Substudy:
* Any medical or psychiatric condition that, in the opinion of the investigator, would make participation in the study unsafe, or would otherwise interfere with the study objectives or interpretation
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00270257
Study Brief:
Protocol Section:
NCT00270257