Behavioral and Pharmacological Treatments to Enhance Weight Outcomes After Metabolic and Bariatric Surgery

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other, Behavioral
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
United States
Connecticut
Yale School of Medicine
RECRUITING
New Haven
Contact Information
Primary
Valentina Ivezaj, Ph.D.
valentina.ivezaj@yale.edu
203-785-7210
Backup
Carlos M Grilo, Ph.D.
carlos.grilo@yale.edu
203-785-7210
Time Frame
Start Date: 2022-01-13
Estimated Completion Date: 2028-01-12
Participants
Target number of participants: 160
Treatments
Experimental: BWL + NB medication
Participants randomly assigned to this arm will receive 6 months of Behavioral Weight Loss (BWL) counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form.
Experimental: BWL + Placebo
Participants randomly assigned to this arm will receive 6 months of Behavioral Weight Loss (BWL) counseling and placebo. Placebo will be inactive and taken daily in pill form.
Experimental: NB medication
Participants randomly assigned to this arm will receive 6 months of NB medication taken daily in pill form.
Placebo_comparator: Placebo
Participants randomly assigned to this arm will receive 6 months of placebo. Placebo will be inactive and taken daily in pill form.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Yale University

This content was sourced from clinicaltrials.gov