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 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT03213418
Eligibility Criteria:
Inclusion Criteria
1. Be between the ages of 18 to 55 years of age.
2. Have an estimated average daily consumption of greater than 10 cigarettes.
3. Have a Fagerstrom Nicotine Dependence Scale (FTND) \>= 5.
4. Is willing to try a method of smoking cessation without using any pharmacologic help for 3 months.
Exclusion Criteria
1. Present with a serious psychiatric illness or substantial suicide or violence risk, as assessed by a licensed clinician involved in the screening phase of the study.
2. Present with any history or current substance use disorder (other than tobacco use disorder), or significant substance use for any substance other than nicotine, alcohol or caffeine, defined as greater than once weekly use.
3. Legally mandated to complete a substance abuse treatment program.
4. Express a desire or intent to obtain additional substance abuse treatment while in the study.
5. Have history of psychotic symptoms such as hallucinations and delusions.
6. Have history of using other smoking cessation treatment, either psychotherapeutic or pharmacologic, in the past 2 months.
7. Have history of any chronic medical or ophthalmologic diseases that may affect retinal function (including but not limited to diabetes, age related macular degeneration, retinitis pigmentosa, narrow angle glaucoma, or neurological conditions, such as Parkinson's disease) and that may affect ERG recordings.
8. The use of any prescription or over the counter medication that may affect the retinal dopamine system, including bromocriptine, antipsychotics, or anticholinergics.
9. If female, be currently pregnant, breastfeeding, or lack of effective birth control during 15 days prior to before the ERG.
10. The use of stimulant medications in the past 12 months.
11. Have a known hypersensitivity to stimulant medications
12. Have history of medical condition that contraindicates the use of methylphenidate, including any history of significant cardiovascular disease or abnormal screening EKG.
13. Is unable to understand or consent to study procedure, or is in the opinion of the study clinician to be unlikely to be able to tolerate the study treatment procedure.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03213418
Study Brief:
Protocol Section:
NCT03213418