Pharmacological and Behavioral Treatment After Bariatric Surgery

  • STATUS
    Recruiting
  • End date
    Jan 12, 2028
  • participants needed
    160
  • sponsor
    Yale University
Updated on 10 March 2022
bariatric surgery
gastric bypass
sleeve gastrectomy

Summary

This study will compare the effectiveness of behavioral and pharmacologic treatment, alone and combined, for improvements in weight loss, cardiovascular risk factors, and psychosocial functioning following metabolic and bariatric surgery.

Description

Metabolic and bariatric surgery is currently the most effective treatment for severe obesity; however, a substantial proportion of patients attain suboptimal weight losses and continue to struggle with obesity, weight regain, and related medical comorbidities after surgery. Thus, this study aims to perform a randomized double-blind placebo-controlled study to test the effectiveness of a rigorous manualized behavioral weight loss treatment and a FDA-approved weight loss agent (naltrexone+bupropion), alone and in combination, for improving weight loss, cardiovascular risk factors, and psychosocial functioning after metabolic and bariatric surgery. This study will produce important new clinical findings regarding the utility and effectiveness of pharmacotherapy and behavioral weight loss for a rapidly growing obesity subgroup and will inform care models for managing chronic and refractory obesity to enhance outcomes after metabolic and bariatric surgery.

Details
Condition Obesity
Treatment Placebo, Behavioral Weight Loss, Naltrexone and Bupropion Combination
Clinical Study IdentifierNCT05157698
SponsorYale University
Last Modified on10 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study (up to 18 months: 6-month treatment plus 12-month follow up)
Have a BMI ≥30 (or BMI ≥27 with a medical comorbidity) and BMI ≤50 kg/m2
Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy
Suboptimal weight outcomes after MBS
Be an otherwise healthy subject without uncontrolled medical problems, as determined by the study physician and medical co-investigators (physical examination, laboratory studies)
Have had a physical in the past year
Read, comprehend, and write English at a sufficient level to complete study-related materials
For females of reproductive potential: use of highly effective contraception and agreement to use such a method during study participation
For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner

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 a contraindication to NB medication (e.g., MAOI, opiates)
Is currently using other medications for weight loss
Has a history of allergy or sensitivity to bupropion or naltrexone
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 hypertension
Has current uncontrolled Type I or Type 2 diabetes mellitus
Has untreated hypothyroidism with a TSH > 1.5 times the upper limit of normal for the test laboratory with repeat value that also exceeds this limit
Has gallbladder disease
Has a history of severe renal, hepatic, neurological, chronic pulmonary disease, or any other unstable medical disorder
Has a recent history of drug or alcohol dependence
Is currently in active effective treatment for eating or weight loss such as behavioral weight loss of FDA-approved weight loss medications
Is currently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or device
Is breast-feeding or is pregnant or is not using a reliable form of birth control
Reports active suicidal or homicidal ideation
Has poor eye health
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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