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New combo therapy aims to boost weight loss and smoking cessation before bariatric surgery

NCT ID NCT07398404

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times

Summary

This study tests a program that combines medication (Naltrexone + Bupropion) with behavior therapy to help adults lose weight and quit smoking before bariatric surgery. Researchers will compare this approach to standard care in 64 participants aged 18-65 who smoke and have obesity. The goal is to see if the program is feasible and acceptable, and to measure weight change and smoking cessation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Medical University of South Carolina

    Charleston, South Carolina, 29407, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.