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 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT03156660
Eligibility Criteria:
Inclusion Criteria:
* Participants must wish to quit smoking in the next 30 days
* Have smoked 5 or more cigarettes a day for at least 1 year
* Participants must be 18 years or older as the safety and efficacy of varenicline therapy has not been established for pediatric patients
* Participants must have a BMI of 22 kg/m2 or greater, as it would not be recommended to have those who are underweight or the lower end of the normal BMI range attempt a 5% weight loss (if assigned to the Group 2 condition)
* Participants must have access to a telephone and daily access to email, if using a cell phone, participants must be willing to use their cell phone minutes for weekly phone interventions
* Participants must have the ability to understand consent process in English
* If female and of childbearing age, participant must have a negative pregnancy test and must agree to use contraception during participation in the study
* All participants must be willing to be randomized to the study conditions and wait eight weeks prior to beginning smoking cessation (during which they will participate in the weight management intervention to which they are assigned).
* Participants must have BP \< 150/95 and a heart rate of \>40 beats per minute and \<120 beats per minute.
Exclusion Criteria:
* Participants must not have a known contraindication, allergy or hypersensitivity to varenicline therapy
* Participants must not currently (in the previous 30 days) be participating in other behavioral or pharmacologic weight or smoking cessation interventions
* Participants must not have had weight loss surgery (hx of gastric bypass, stomach stapling or banding)
* Participants must not have lost \> or equal to10 lbs in the past 6 months
* Participants must not be taking a medication that impacts weight
* Participants must not have used an investigational drug within the last 30 days
* Participants must not have current suicidal thoughts or have a lifetime history of a suicide attempt as defined by the Columbia-Suicide Severity Rating Scale (C-SSRS)
* Participants must not self-report a history of psychosis, bipolar disorder, or anorexia nervosa
* Participants must not have self-reported current alcohol abuse or illicit substance use
* Participants must not have kidney or liver disease, unstable cardiovascular conditions, HIV, or history of cancer in last 5 years
* Participants must not have another member of their household already participating in this study
* Participants must not be currently pregnant or lactating or planning to become pregnant in the next 12 months, or have been pregnant within the last 6 months
* Weight limit of 385 pounds
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03156660
Study Brief:
Protocol Section:
NCT03156660