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 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT00149669
Eligibility Criteria:
Volunteers were eligible to participate if they
* were between the ages of 18 and 65 years,
* were unemployed (i.e., reporting no work in the past 30 days and earning $200 in taxable income per month),
* self-reported injection drug use and had visible track marks (assessed via visual inspection),
* provided a urine sample that tested positive for both opiates and cocaine upon entry into detoxification,
* met DSM-IV-TR criteria for opiate dependence,
* were medically approved to be maintained on naltrexone by the study physician,
* and lived within reasonable commuting distance to the research unit (i.e., in Baltimore City and the immediate surrounding area).
Volunteers were excluded if they
* had active hallucinations, delusions, or a thought disorder;
* were judged to be of imminent threat to harm self or others;
* were currently incarcerated, in a halfway house, or under constant monitoring;
* were pregnant or breastfeeding;
* had serum aminotransferase levels over 3 times normal;
* required opiates for other medical problems (and thus could not be maintained on naltrexone, which would block the effects on any opiate);
* reported an interest in methadone treatment;
* had active tuberculosis;
* or had physical limitations that would prevent typing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00149669
Study Brief:
Protocol Section:
NCT00149669