Naltrexone + Bupropion + Cognitive Behavioral Therapy for Smoking Cessation and Obesity

Overseen By Caitlin E Smith, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Yale University

Must not be taking: Opiates, Benzodiazepines, MAOIs

Disqualifiers: Seizure disorders, Hypertension, Cardiac issues, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether a combination of medications—Naltrexone and Bupropion, used for smoking cessation and weight loss—and Cognitive Behavioral Therapy can help people lose weight and quit smoking, particularly those considering bariatric surgery. Participants will receive these treatments for four months. The trial seeks adults who have smoked at least five cigarettes a day for the past three months, have a BMI of 30 or higher, and are not on medications that could interfere with the trial drugs. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative combination therapy.

Will I have to stop taking my current medications?

You may need to stop taking certain medications if they interact with Naltrexone or Bupropion, such as opiates or benzodiazepines. The trial does not specify a washout period, but you should discuss your current medications with the study team to see if any changes are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that taking naltrexone and bupropion together can cause some side effects. One study found that about 40% of participants experienced side effects, and around 33% had more than one symptom. Although these numbers might seem high, not everyone discontinues treatment because of them. Bupropion alone has been shown to aid weight loss, but when combined with naltrexone, the effects on smoking and weight loss varied.

This trial is in its early stages, focusing mainly on safety, meaning the treatment is still being tested for tolerability. The combination of naltrexone and bupropion is approved for other uses, providing some safety information. However, side effects can occur, and each person's experience may differ. Always consult a healthcare provider to understand any risks better. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Naltrexone and Bupropion with Cognitive Behavioral Therapy for smoking cessation and obesity because it tackles both nicotine addiction and weight management simultaneously. Unlike standard treatments that might focus solely on one issue, this approach uses Naltrexone and Bupropion to target the brain's reward system, reducing cravings and withdrawal symptoms for smokers while also helping to curb appetite. Additionally, Cognitive Behavioral Therapy provides essential behavioral support, addressing the psychological aspects of both smoking and overeating, which can lead to more sustainable lifestyle changes. This combined method could offer a more comprehensive solution for individuals struggling with both challenges.

What evidence suggests that this trial's treatments could be effective for smoking cessation and obesity?

Studies have shown that using Naltrexone and Bupropion together can aid in weight loss and smoking cessation. Research indicates that this treatment leads to significant weight loss when combined with lifestyle changes. In one study, participants lost an average of about 8 pounds and reduced their waist size. For quitting smoking, another study found that this combination works as well as other treatments. In this trial, participants will receive Naltrexone and Bupropion combined with Cognitive Behavioral Therapy, which may effectively support those trying to quit smoking and lose weight. ^{1 2 3 4 5}

Who Is on the Research Team?

Caitlin E Smith, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults who are preparing for bariatric surgery and want to quit smoking and lose weight. Participants should be current smokers with obesity, intending to undergo bariatric surgery. Specific eligibility details are not provided, but typically include being medically stable and able to adhere to the study protocol.

Inclusion Criteria

Smoke at least 5 cigarettes daily for the past 3 months

Have a BMI ≥ 30.0 kg/m2

Speak/read/write in English

Exclusion Criteria

Has a history of anorexia nervosa or history of bulimia nervosa

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a multiple health behavior change intervention with combined medication (Naltrexone + Bupropion) and behavior therapy for weight loss and smoking cessation

16 weeks

Weekly sessions

Follow-up

Participants are monitored for weight loss and smoking cessation post-treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive-Behavioral Therapy
• Naltrexone + Bupropion

Trial Overview The trial is testing a combined approach using medication (Naltrexone Hydrochloride + Bupropion HCl Extended Release) alongside Cognitive-Behavioral Therapy (CBT) to help participants stop smoking and lose weight before their bariatric surgery.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 3 Interventions

Participants will receive the multiple health behavior change intervention with combined medication (Naltrexone 50mg/day; Bupropion Extended Release 300mg/day) and behavior therapy (Cognitive-Behavioral Therapy) for 4 months.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

American Society for Metabolic and Bariatric Surgery

Collaborator

Trials

5

Recruited

250+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5850123/

Naltrexone and Bupropion Combination Treatment for ... This study was to examine whether naltrexone and bupropion combination treatment can help weight loss and smoking cessation in patients with schizophrenia.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306460309002962

An open-label study of naltrexone and bupropion ... In a small, short-term (7-week), open-label study in non-obese adults, naltrexone/bupropion combination therapy produced smoking cessation rates similar to ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02736474

Study Details | NCT02736474 | Naltrexone and Bupropion ... The purpose of this research is to observe the efficacy of Naltrexone and Bupropion combination on weight loss and smoking cessation from baseline to week ...

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. 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 ...