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 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT01110434
Eligibility Criteria:
Inclusion Criteria:
* 15 to 20 years old (inclusive)
* Non-treatment seeking for cannabis abuse or dependence
* Able to read English, understand their rights as provided by the informed consent process, and be willing to sign an informed consent form to participant in the study
* If younger than 18 years old, informed consent from a parent or legal guardian is required
* Used cannabis at least 2 days per week during the past 30 days
Exclusion Criteria:
* Treatment seeking or a recent history of treatment for cannabis abuse or dependence
* Endorses a current commitment to stop using cannabis
* Clinically significant physical abnormalities as indicated by physical exam, hematological assessment, bilirubin concentration or urinalysis
* History of renal impairment, renal stones, seizures, or unstable hypertension
* Underweight (i.e., less than the 5th percentile) or overweight (equal to or greater than the 95th percentile), as determined by the Body Mass Index
* Positive urine toxicology screen for narcotics, amphetamines, or sedative hypnotics or self-reported drug use, other than cannabis, alcohol or nicotine, in the past 30 days
* Pregnant, nursing, or refusal to use reliable barrier method of birth control (e.g., condom), if female
* Took a psychotropic medication in the past 30 days
* Taking medications with a potential effect on cannabis use or a carbonic anhydrase inhibitor
* Suicidal
* A current DSM-IV-TR Axis I diagnosis other than attention- deficit/hyperactivity disorder or a disruptive behavior disorder
* A current substance use disorder other than a cannabis, alcohol, and nicotine use disorders
* Significant alcohol withdrawal symptoms
* Known sensitivity to topiramate
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
20 Years
Study:
NCT01110434
Study Brief:
Protocol Section:
NCT01110434