Contrave for Obesity

Recruiting at 2 trial locations

Overseen By Natalia Jaworska, Ph.D

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: The Royal's Institute of Mental Health Research

Must be taking: Contrave

Must not be taking: Antidepressants, Thyroid meds, MAO inhibitors, others

Disqualifiers: Severe depression, Diabetes, Cardiac defects, others

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

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the weight-loss drug CONTRAVE® affects the brain and body in people with obesity. Researchers will compare the effects of CONTRAVE® with a placebo (a non-active pill) while both groups follow a diet plan. The trial will examine changes in mood, body composition, metabolic measures, and brain activity over four weeks. Individuals with obesity who have been referred to or self-referred to the LEAF clinic for weight loss and do not have conditions like diabetes, severe depression, or a history of eating disorders may be suitable for this study. As a Phase 4 trial, this study involves an FDA-approved treatment and seeks to understand how CONTRAVE® benefits more patients.

Will I have to stop taking my current medications?

The trial requires participants to stop taking certain medications, including antidepressants, thyroid medication, and any medication that could affect appetite or seizure threshold. If you are currently taking these or other specified medications, you may need to stop them to participate.

What is the safety track record for Contrave?

Research has shown that Contrave, a medication combining naltrexone and bupropion, is generally safe for use. Studies have found that individuals taking Contrave for weight loss often lose more weight than those on a placebo. However, like any medication, it carries some risks.

Common side effects include nausea, headaches, and dizziness, typically mild to moderate. Serious side effects are rare but can involve increased blood pressure and heart rate. Both the FDA and Health Canada have approved Contrave for treating obesity, indicating it has passed extensive safety tests.

For those considering a trial with Contrave, it is reassuring to know it has a strong safety record based on past studies and approvals. Nonetheless, discussing any concerns with a doctor is always wise. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Contrave for obesity because it combines two active ingredients, naltrexone and bupropion, which work together to help control appetite and cravings. Unlike traditional treatments that often target just hunger, Contrave addresses both the psychological and physiological aspects of eating. This dual-action approach makes it stand out from other weight-loss medications, potentially offering more comprehensive results for those struggling with obesity.

What is the effectiveness track record for CONTRAVE® in treating obesity?

Research has shown that CONTRAVE® aids weight loss in people with obesity. In studies, individuals taking CONTRAVE® lost 2-4 times more weight than those relying solely on diet and exercise. In this trial, participants in the CONTRAVE® arm will follow a diet program alongside CONTRAVE®. After 12 weeks, many on CONTRAVE® lost at least 5% of their weight. This drug combines two medicines, naltrexone and bupropion, which work together to reduce hunger and cravings. Overall, CONTRAVE® has been proven to lead to more weight loss than a placebo when used with a low-calorie diet. ^{2 3 6 7 8}

Who Is on the Research Team?

Pierre Blier, M.D., Ph.D

Principal Investigator

University of Ottawa

Are You a Good Fit for This Trial?

This trial is for adults aged 18-64 with obesity (BMI >30) who can consent, speak English, and have internet access. They should be referred to the LEAF clinic for weight loss. Exclusions include heart or eye conditions, seizure history, certain medications including opioids and ADHD treatments, thyroid/liver/kidney diseases, pregnancy/nursing status, allergies to CONTRAVE®, specific dietary intolerances, substance abuse disorders, severe depression or bipolar disorder.

Inclusion Criteria

Participants who are able to provide written informed consent prior to the initiation of any protocol-required procedures

Participants able to participate in the study protocol as described

Participants with access to a secure internet connection

Exclusion Criteria

I have a history of glaucoma.

Participants with exclusionary criteria for brain imaging/MRI and EEG

Participants with current or past history of addictions or substance use disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo baseline assessments including body composition, EEG, and MRI scans

1 week

2 visits (in-person)

Treatment

Participants receive either CONTRAVE® or placebo along with a diet program for 4 weeks

4 weeks

Weekly virtual check-ins with dietitian

Post-Intervention Assessment

Participants repeat the baseline assessments to evaluate changes after the 4-week intervention

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Contrave
• Diet Program

Trial Overview The study compares the effects of a diet program combined with either CONTRAVE® or a placebo on mood changes, body composition alterations, metabolic functions and brain activity over four weeks. Participants will undergo various tests including EEGs and MRIs before and after treatment to assess these outcomes.

How Is the Trial Designed?

Group I: CONTRAVE Experimental Treatment 2 Interventions

A diet program + CONTRAVE®

Group II: Placebo Placebo Group 2 Interventions

Diet Program + Placebo

Who Is Running the Clinical Trial?

The Royal's Institute of Mental Health Research

Lead Sponsor

Trials

8

Recruited

1,300+

The Royal Ottawa Mental Health Centre

Collaborator

Trials

24

Recruited

2,300+

LEAF Weight Management Clinic

Collaborator

Trials

1

Recruited

40+

Bausch Health, Canada Inc.

Collaborator

Trials

3

Recruited

150+

University of Ottawa

Collaborator

Trials

231

Recruited

267,000+

CHEO Research Institute

Collaborator

Trials

3

Recruited

1,100+

Cheo Research Institute

Collaborator

Published Research Related to This Trial

Contrave, a combination of naltrexone and bupropion, is being tested in Phase III clinical trials for obesity treatment, showing promising efficacy in preliminary studies.

Orexigen Therapeutics, the company behind Contrave, is currently working to address safety concerns raised by the FDA as they plan their next steps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACS chemical neuroscience molecule spotlight on contrave. Mercer, SL.[2021]

Naltrexone/bupropion ER, marketed as Contrave, is a newly approved medication specifically designed for chronic weight management in obese adults.

This combination therapy targets both appetite suppression and energy expenditure, offering a new option for individuals struggling with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naltrexone/Bupropion ER (Contrave): Newly Approved Treatment Option for Chronic Weight Management in Obese Adults. Sherman, MM., Ungureanu, S., Rey, JA.[2020]

Losing just 5% of body weight can lead to significant health improvements, but many individuals struggle to maintain weight loss through diet and exercise alone, highlighting the need for additional treatment options.

As of 2012, two new medications, lorcaserin and phentermine/topiramate, have been approved for long-term obesity treatment, and bariatric surgery is recommended for patients with severe obesity (BMI ≥40 or ≥35 with comorbidities) as a more intensive intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity consults--comprehensive obesity management in 2013: understanding the shifting paradigm. Kushner, RF., Apovian, CM., Fujioka, K.[2018]

Recent advancements in obesity drug therapy include new combinations of existing medications and higher doses of approved drugs, showing promise for effective weight management.

Despite the potential of these new drugs, challenges such as cost, patient acceptance, and the need for more evidence on long-term cardiovascular benefits remain significant barriers to their integration into clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New medications for treatment of obesity: metabolic and cardiovascular effects. Pucci, A., Finer, N.[2017]

Contrave, a combination of naltrexone and bupropion, was shown to be effective for weight loss in a large study involving 4536 adults over 56 weeks, with participants losing an average of 11-22 lbs (5-9 kg) compared to placebo.

In addition to weight loss, Contrave also led to significant improvements in cardiometabolic markers, highlighting its potential benefits beyond just weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naltrexone/bupropion for the treatment of obesity and obesity with Type 2 diabetes. Apovian, CM.[2016]

Contrave, a combination of bupropion and naltrexone, works by stimulating central melanocortin pathways to increase energy expenditure and reduce appetite, showing promise in treating obesity.

In phase III trials, Contrave demonstrated placebo-subtracted weight losses of 3 to 7% and improvements in obesity-related health issues, although nausea was a common reason for discontinuation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrave, a bupropion and naltrexone combination therapy for the potential treatment of obesity. Padwal, R.[2022]

A comprehensive analysis of the FDA Adverse Event Reporting System revealed 18,675 unique adverse event reports linked to anti-obesity medications (AOMs) among 15,143 patients, highlighting significant safety concerns.

Serious adverse events included a fatality ratio of 4.9%, with cardiovascular complications being particularly prevalent, accounting for 31% of AEs related to phentermine, and indicating a need for ongoing safety monitoring of AOMs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Descriptive analysis of reported adverse events associated with anti-obesity medications using FDA Adverse Event Reporting System (FAERS) databases 2013-2020. Alsuhibani, A., Alrasheed, M., Gari, M., et al.[2022]

Citations

1. 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 ...

2. contrave.com contrave.com/results/

Results | CONTRAVE® (naltrexone HCl/bupropion HCl) In the studies, people taking CONTRAVE lost 2-4x more weight compared to those who used diet and exercise alone. You can learn more about each study below.

3. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(22)00166-3/fulltext

The relationship between early weight loss and ... Extended-release (ER) naltrexone/bupropion (NB) was associated with greater weight loss than placebo in four randomized, 56-week trials.

4. dmsjournal.biomedcentral.com dmsjournal.biomedcentral.com/articles/10.1186/s13098-024-01319-7

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 ...

5. 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 ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf

Contrave - accessdata.fda.gov The safety and effectiveness of CONTRAVE in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and.

7. 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 Contrave ...

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.