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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07398404
Eligibility Criteria:
Inclusion Criteria:
* Be 18-65 years old.
* Be actively considering bariatric surgery.
* Smoke at least 5 cigarettes daily for the past 3 months.
* Have a BMI ≥ 30.0 kg/m2.
* Not currently taking medications that interact with Naltrexone or Bupropion (e.g., opiates, benzodiazepines).
* No history of medical conditions that are contraindicated with Naltrexone or - Bupropion (e.g., seizure disorders, uncontrolled hypertension, cardiac issues including history of heart attacks, heart disease, or stroke, history of anorexia or bulimia nervosa).
* Physically well enough to participate in the intervention (e.g., able to walk independently).
* Speak/read/write in English.
* Not currently pregnant or breastfeeding or have plans to become pregnant or breastfeed during the study.
* No active suicidal or homicidal ideation.
Exclusion Criteria:
* Has an acute medical or psychiatric disorder that would make participation difficult or unsafe.
* Has suicidal or homicidal ideation that requires immediate attention.
* Has a predisposition to seizures (e.g., subject with a history or evidence of seizure disorder, febrile seizures during childhood, brain tumor, cerebrovascular disease, or significant head trauma; has a family history of idiopathic seizure disorder or is currently being treated with medications or treatment regimens that lower seizure threshold).
* Has evidence of a second or third degree heart block, atrial fibrillation, atrial flutter, prolongation of the QTc, or any other finding on the screening electrocardiogram that would preclude safe participation.
* Has stage 2 hypertension (blood pressure greater than 160/100 or heart rate over 100 beats/minute).
* Has elevated bilirubin test or any other liver function test value \> 5 times the upper limit of normal laboratory criteria.
* Has a platelet count \< 100x10 3/uL.
* Has a history of anorexia nervosa or history of bulimia nervosa.
* Is currently taking a medication that is contraindicated to Naltrexone or Bupropion (e.g., MAOIs, opiates).
* Has a history of allergy or sensitivity to Naltrexone or Bupropion.
* Has a co-existing psychiatric condition that requires hospitalization or more intensive treatment (such as bipolar mood disorders, psychotic illnesses, or severe depression).
* Has a history of congenital heart disease, cardiovascular disease, cardiac arrhythmias requiring medication, or a history of cerebrovascular pathology including stroke.
* Has current uncontrolled Type I or Type 2 diabetes mellitus.
* Has a history of severe renal, hepatic, neurological, chronic pulmonary, or gallbladder disease, or any other unstable medical disorder, including cancer.
* Has angle closure glaucoma.
* Has taken an investigational drug in another study within 30 days of study consent.
* Has been prescribed and taken Naltrexone or Bupropion within 30 days of study consent.
* Is concurrently enrolled in formal behavioral or pharmacological Substance Use Disorder treatment.
* Is receiving ongoing treatment with tricyclic antidepressants, xanthines, systemic corticosteroids, nelfinavir, efavirenz, chlorpromazine, MAOIs, central nervous stimulants, or any medication that could interact adversely with the study medications.
* Has a current pattern of alcohol, benzodiazepine, or other sedative hypnotic use which would preclude safe participation in the study.
* Requires treatment with opioid-containing medications during the study period.
* Has a surgery planned other than bariatric surgery.
* Is currently in jail, prison, or any inpatient overnight facility as required by a court of law or have pending legal action or other legal situation that could prevent participation.
* Is currently pregnant, breastfeeding, or plans to become pregnant during the study, or is not using a reliable form of birth control.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07398404
Study Brief:
Protocol Section:
NCT07398404