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 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT01031433
Eligibility Criteria:
* INCLUSION CRITERIA:
1. 18-55 year old males and females
2. Currently smokes at least 5 cigarettes per day
3. Current DSM-IV diagnosis of schizophrenia and stable medication regimen
4. Medically healthy as determined by screening criteria
5. Urine cotinine level greater than or equal to 100 ng/ml (NicAlert reading greater than or equal to 3)
6. Agrees to wear a head mounted display (HMD) for up to 45 minutes
7. Participant able to complete the Evaluation to Sign Consent (ESC) with minimum score of 80 percent on ESC.
EXCLUSION CRITERIA:
1. Interest in reducing or quitting tobacco use within the past 3 months
2. Treatment for tobacco dependence in the past 3 months
3. Use of nicotine replacement products, bupropion, or varenicline in the past 3 months as an aid to quit or reduce smoking.
4. DSM-IV diagnosis of active alcohol or substance abuse in the past 1 month or dependence within the past 6 months
5. Current use of serotonin reuptake inhibitors or any medication that would interfere with the protocol in the opinion of MAI
6. History of head injury, seizures, or stroke
7. Pregnant, nursing, or planning to become pregnant during the study
8. Positive urine toxicology screen for substances other than those used for therapeutic purposes: participants who have an initial positive urine toxicology screen for substances other than those used for therapeutic purposes will have the opportunity to return within two weeks for a second toxicology screen. If at that time the results are again positive, the participants will be excluded.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01031433
Study Brief:
Protocol Section:
NCT01031433