Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New combo therapy aims to help bariatric patients drop weight and kick the habit before surgery

NCT ID NCT07224087

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 10, 2026 · Updated 5 times

Summary

This early-stage study at Yale is testing whether a combination of two medications (naltrexone and bupropion) plus cognitive-behavioral therapy can help people who are considering bariatric surgery lose weight and stop smoking. Twenty participants will receive the treatment for four months. The main goal is to see if the program is feasible and acceptable, not yet to prove it works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Naltrexone and Bupropion
What this could lead to
If successful, this could point toward an effective pre-surgery program that helps patients lose weight and stop smoking before bariatric surgery, potentially improving surgical outcomes.
What could go wrong
This is a very early Phase 1 pilot with only 20 participants, so results may not apply broadly. The medications have known side effects and interactions, and the program may not work for everyone.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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 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. * Be 18-65 years old. * 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 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 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 untreated hypertension with a seated systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 100 mmHg, or heart rate \> 100 beats/minute. * 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. * Is breast-feeding or is pregnant or is not using a reliable form of birth control. * Reports active suicidal or homicidal ideation.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Bariatric surgery patients are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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.