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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT01500018
Eligibility Criteria:
Inclusion Criteria:
* Current recreational polydrug users with experience with at least 2 drug classes of abuse.
* At least 10 lifetime uses of stimulants drugs (eg, amphetamine, cocaine, methamphetamine) and 10 lifetime occasions of recreational use of psychedelic drugs (eg, cannabis, ketamine, dextromethorphan, PCP, MDMA \[ecstasy\], LSD, mesacline, or psilocybin).
* Recreational use of other classes of drugs is permitted, including opioids (eg, codeine, morphine, or heroin), minor tranquilizers, or sedatives (eg, benzodiazepines or barbiturates).
* Male or female volunteers aged 18 to 55, inclusive with a body mass index (BMI) within the range of 19.0 to 33.0 kg/m2, inclusive, and a minimum weight of 50.0 kg at screening.
* Must pass qualification phase eligibility criteria.
Exclusion Criteria:
* Self-reported history of drug or alcohol dependence (except caffeine) in the past 12 months, including subjects who have ever been in a drug rehabilitation program (other than treatment for smoking cessation).
* Unwillingness or inability to abstain from recreational drug use for the duration of the study from screening until follow-up.
* Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at screening.
* Any significant unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or any other medical conditions that might confound the study or put the volunteer at greater risk during study participation.
* Currently smoking more than 20 cigarettes (or 2 cigars) per day, and/or unwillingness to abstain from smoking for durations of at least 12 hours.
* Use of tobacco cessation product within 1 month (eg, nicotine substitution products, bupropion, etc).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01500018
Study Brief:
Protocol Section:
NCT01500018