Naltrexone/Bupropion for Obesity

Overseen By Mélanie Nadeau

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Laval University

Must not be taking: Opioids, MAO inhibitors, Antipsychotics, others

Disqualifiers: Pregnancy, Hypertension, Seizures, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

108 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a combination of two medications, Naltrexone and Bupropion (used for weight management), affects individuals who have undergone sleeve gastrectomy surgery for obesity. Researchers aim to determine if this combination aids in further weight loss, improves related health issues, and alters eating habits compared to a placebo. Participants will begin the medication one month post-surgery and will receive behavioral and nutritional support. Suitable candidates have a body mass index (BMI) over 30 with obesity-related health problems or a BMI over 35 without additional health issues. As a Phase 4 trial, this research seeks to understand how the already FDA-approved treatment benefits a broader patient population.

Will I have to stop taking my current medications?

You may need to stop taking certain medications to join this trial. Specifically, you cannot use other weight loss medications, bupropion-containing products, monoamine oxidase inhibitors, CYP2B6 inhibitors, or the antipsychotic thioridazine. If you are on any of these, you should discuss with the trial team.

What is the safety track record for Naltrexone/Bupropion?

Research has shown that combining Naltrexone and Bupropion is generally safe and effective for weight management. Studies have found that individuals using this treatment can lose more weight than those taking a placebo. This combination has already received approval for treating obesity, indicating it has passed strict safety tests for that use.

Most people tolerate the treatment well, though some may experience side effects like nausea, headache, or dizziness. These side effects are usually mild and often resolve over time. Prospective participants in a clinical trial with this treatment can use this information to understand what to expect regarding safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Naltrexone/Bupropion is unique for obesity treatment because it combines two active ingredients that work together to reduce cravings and appetite. While traditional options like lifestyle changes, orlistat, and liraglutide focus on altering metabolism or blocking fat absorption, this combination targets the brain's reward system, potentially leading to better control over eating habits. Researchers are excited because this dual-action approach could offer a more effective way to manage weight, especially for those who haven't had success with other treatments.

What evidence suggests that Naltrexone/Bupropion might be an effective treatment for obesity?

Research has shown that a combination of Naltrexone and Bupropion (NB) can aid in weight loss. In earlier studies, individuals using this treatment alongside a low-calorie diet lost a noticeable amount of weight. Specifically, some results indicated that participants could lose about 5% of their body weight within 12 weeks of starting the treatment. Another study found that this combination led to more weight loss compared to some other weight loss medications. In this trial, participants will receive either the NB combination or a placebo, along with lifestyle changes, to evaluate its effectiveness in aiding weight loss over time. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with a BMI over 30 who have obesity-related health issues, or those with a BMI above 35 without such conditions. Participants must be post-operative sleeve gastrectomy patients.

Inclusion Criteria

My BMI is over 30 with health issues related to obesity or over 35 without them.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo sleeve gastrectomy surgery

1 month

Treatment

Participants receive Naltrexone/Bupropion or placebo starting one month after surgery, with progressive dosing adjusted according to tolerance and side-effects

24 months

Follow-up

Participants are monitored for weight loss, resolution of comorbidities, and eating behaviors

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Naltrexone/Bupropion

Trial Overview The study tests if adding Naltrexone/Bupropion to the post-surgery treatment plan of sleeve gastrectomy patients leads to better weight loss and comorbidity resolution compared to a placebo, over a period of 24 months.

How Is the Trial Designed?

Group I: Naltrexone/Bupropion Experimental Treatment 1 Intervention

Patients will be started one month after sleeve gastrectomie on a progressive dose of Naltrexone/Bupropion extended-release 8mg/90mg, up to 2 tabs twice a day (32mg/360mg) adjusted according to tolerance and side-effects.

Group II: Placebo Placebo Group 1 Intervention

Patients will be started one month after sleeve gastrectomie on a progressive numbers of matched placebo tablets up to 2 tabs twice a day

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Bausch Health Canada

Collaborator

Trials

1

Recruited

110+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11044307/

The effects of bupropion alone and combined with naltrexone ... The pooled findings showed that bupropion administration has an effect on lowering weight (WMD: -3.67 kg, 95% CI: -4.43 to -2.93) and WC (WMD: -2.98 cm, 95% CI ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2667368125000142

Appropriate use of the fixed-dose, extended-release ... In previous studies, patients taking NB-ER achieved significant weight reduction compared with placebo when treatment was combined with a reduced-calorie diet ...

3. nature.com nature.com/articles/s41366-024-01526-2

Effect of combined GLP-1 analogue and bupropion ... GLP-1 analogues are an effective treatment for weight loss, and the addition of bupropion/naltrexone is associated with greater weight loss.

4. karger.com karger.com/ofa/article/18/5/481/925952/The-Effectivity-and-Safety-of-Naltrexone-Bupropion

The Effectivity and Safety of Naltrexone/Bupropion in ... Conclusion: NB treatment combined with lifestyle intervention results in significant weight loss after 6 and 12 months. Despite high ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4771085/

Naltrexone/Bupropion ER (Contrave) - PubMed Central - NIH After 12 weeks of treatment with naltrexone/bupropion, a patient should have achieved at least a 5% weight loss since initiation of therapy. If this result is ...

6. medsafe.govt.nz medsafe.govt.nz/profs/PUArticles/June2025/Spotlight-on-Contrave.html

Spotlight on Contrave (naltrexone + bupropion) Contrave contains naltrexone and bupropion and is indicated for weight management in adults. Significant safety issues associated with ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8314402/

Safety and efficacy of naltrexone for weight loss in adult patients Our systematic review suggests that naltrexone/bupropion treatment is effective in the accomplishment of weight loss amongst overweight subjects.

8. mayoclinic.org mayoclinic.org/drugs-supplements/naltrexone-and-bupropion-oral-route/description/drg-20122495

Naltrexone and bupropion (oral route) - Side effects & ... Naltrexone and bupropion combination is used together with a reduced-calorie diet and proper exercise to help lose weight.