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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT02556060
Eligibility Criteria:
Inclusion Criteria:
1. Current users of ketamine, including having a ketamine-positive urine
2. Meeting DSM-5 criteria for ketamine use disorder
3. Age between 18 to 65 years old
4. Women of childbearing age must have a negative pregnancy test to enroll in this study, agree to monthly pregnancy testing, and agree to use appropriate forms of birth control for the duration of the study.
Exclusion Criteria:
1. Significant medical conditions such as abnormal liver function or renal function confirmed by laboratory tests
2. Hypertension
3. A current cardiac condition or high risk of cardiovascular disease
4. Seizure disorders
5. Any another significant underlying medical condition which would contraindicate lamotrigine treatment
6. Meeting DSM-IV psychiatric classifications for schizophrenia, bipolar disorder, or other psychotic disorders
7. Meeting DSM-IV psychiatric classifications for substance use disorder other than ketamine within three month except tobacco or caffeine.
8. Exhibiting current suicidality or homicidality
9. Pregnant women, lactating women or women who are planning to be pregnant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02556060
Study Brief:
Protocol Section:
NCT02556060