Evaluation of the efficacy of Naltrexone/Bupropion in patients with weight regain, or insufficient weight loss. after Stomach Reduction surgery

Evaluation of the efficacy of Naltrexone/Bupropion in patients with Weight Regain, or Insufficient Weight Loss. after Bariatric Surgery: a Prospective study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-789gmdf

Enrollment

105

Registered

2026-03-18

Start date

2024-04-01

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight gain Obesity

Interventions

A total of 105 patients will be selected for a single-arm study, with no randomization, blinding, or placebo group

only the treatment group will be included. Treatment will consist of naltrexone/bupropion for 7 months, with the first month used for dose titration to reach 4 tablets per day (360 mg of bupropion and

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients who underwent bariatric surgery at least 18 months earlier and experienced weight regain (at least 10 kg or a 5-point increase in body mass index), or insufficient weight loss (less than 50% of excess weight loss).

Exclusion criteria

Exclusion criteria: Exclusion criteria include pregnancy; breastfeeding; and the use of medications with known interactions with naltrexone or bupropion (ticlopidine; clopidogrel; ritonavir; lopinavir; efavirenz; carbamazepine; phenobarbital; and phenytoin); prior use of bupropion or naltrexone; use of anti-obesity medications; bipolar affective disorder; previous cardiovascular events

Design outcomes

Primary

Measure	Time frame
The objective of this study is to evaluate whether patients who have undergone bariatric surgery and experienced weight regain or a weight-loss plateau while still living with obesity achieve clinically significant weight loss (at least 5%) with the use of naltrexone/bupropion.	—

Secondary

Measure	Time frame
To evaluate whether there is improvement in binge eating severity, as assessed by the Binge Eating Score, and in quality of life, as measured by the 36 item Short Form Health Survey, before and after treatment.;To evaluate whether there is any effect on the maintenance of the weight lost six months after treatment discontinuation.	—

Countries

Contacts

Public ContactGuilherme Vaccarezza

Irmandade da Santa Casa de Misericórdia de São Paulo

ouvidoria@santacasasp.org.br+55 11 2176-7000

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Apr 4, 2026