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 @ 7:19 PM
Ignite Modification Date:
2025-12-24 @ 7:19 PM
NCT ID:
NCT04035603
Eligibility Criteria:
Inclusion Criteria: (open phase)
* daily smoker for at least one year, smoking an average of at least 10 cigarettes per day, and motivated to quit smoking (\>5 on a 10 point scale)
* had reactivity to in vivo smoking cues (an increase of two points or maximal score of 10 on a 10 point visual analogue craving scale \[VAS\]) following no smoking for a minimum of two hours
* medical clearance to participate in the protocol
Exclusion Criteria:
* use of other tobacco products
* current unstable medical illness (i.e. deemed as at high risk of significant worsening by study intervention procedures by study physician; e.g. heart disease, chronic obstructive pulmonary disease, or seizure disorders - assessed during telephone prescreen and initial assessment), seizure disorder, pregnancy, breastfeeding, or use of isoniazid or ethionamide
* lifetime history of psychotic disorders or uncontrolled bipolar disorder, by DSM-5 criteria as assessed by the MIni International Neuropsychiatric Interview
* substance use disorder other than nicotine or caffeine active in the past 6 months, or excessive concurrent alcohol use as defined by self-report of an average of \>21 standardized drinks per week for males or \>14 standardized drinks per week for females
* elevated suicide risk as determined by clinician interview
* current use of any psychotropic medications or pharmacotherapy or psychotherapy for smoking cessation not provided by the investigators during the quit attempt
* known hypersensitivity to DCS
* insufficient command of the English language or inability to understand study procedures and participate in the informed consent process
To progress to the randomized phase:
* participants must achieve a 24 hour abstinence period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04035603
Study Brief:
Protocol Section:
NCT04035603