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 @ 9:33 PM
Ignite Modification Date:
2025-12-24 @ 9:33 PM
NCT ID:
NCT01893632
Eligibility Criteria:
Inclusion Criteria:
1. Meets DSM-IV-TR criteria for BZD dependence
2. Using BZDs a minimum of 5 days per week over the past 28 days
3. Between the ages of 18 and 60
4. Able to provide informed consent
Exclusion Criteria:
1. Any current DSM-IV-TR Axis I psychiatric disorder, other than BZD dependence, that might require intervention over the course of the study, including schizophrenia, bipolar disorder, major depressive disorder or panic disorder.
2. Receiving psychotropic medication other than BZDs
3. Evidence of physiological BZD withdrawal (pulse \> 100; blood pressure \> 140/90)
4. History of BZD withdrawal seizures or withdrawal delirium
5. History of allergic reaction to GBP
6. Pregnancy, lactation, or failure in female patients to use adequate contraceptive methods
7. Unstable physical disorders which might make participation hazardous medical history
8. Subjects who have a current DSM-IV-TR diagnosis of other substance dependence, with the exception of nicotine and caffeine history; dependence
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01893632
Study Brief:
Protocol Section:
NCT01893632