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 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT02968602
Eligibility Criteria:
Inclusion Criteria
* DSM-IV or DSM-5 diagnosis of schizophrenia or schizoaffective disorder
* Male or Female
* Age: 18 to 65 years
* Caucasian or Non-Caucasian
* Smoke at least 10 cigarettes daily
* Urine cotinine level ≥ 100 ng/ml (NicAlert® reading ≥ 3)
* Agrees to wear a head mounted display (HMD) for up to 45 minutes
* Able to complete the Evaluation to Sign Consent (ESC) with minimum score of 80%
Exclusion Criteria
* History of organic brain disease
* DSM-IV diagnosis of Alcohol or Substance Dependence within the last six months (except nicotine) or DSM-5 diagnosis of Substance Use Disorder in the last six months (except nicotine)
* DSM-IV diagnosis of Alcohol or Substance Abuse within the last one month (except nicotine) or DSM-5 diagnosis of Substance Use Disorder in the last six months (except nicotine)
* Pregnancy or lactation
* Severe liver dysfunction (LFT 3X upper limit of normal)
* Previous known hypersensitivity to tetracyclines
* Current treatment with tetracycline or derivative
* Treatment with oral contraceptives (unless a second form of birth control is used and documented)
* Treatment with cholestyramine or colestipol
* Treatment with Urinary alkalinizers (e.g., sodium lactate, potassium citrate)
* Treatment with warfarin
* Treatment with bupropion, varenicline, or nicotine replacement products in the month prior to study inclusion
* Less than two months treatment of adjunctive medications AND less than one month on same dose: beta blockers, antidepressants, mood stabilizers, antianxiety medications.
* Medical condition whose pathology or treatment would significantly increase the risk associated with the proposed protocol.
* History of head injury, seizures, or stroke
* Positive urine toxicology screen for substances of non-therapeutic use prior to craving assessments
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02968602
Study Brief:
Protocol Section:
NCT02968602