← Back to all trials
Completed
NCT04599504
Pharmacological and Behavioral Treatment After Bariatric Surgery: Medication Change for Non-Responders (Stage 2b)
Conditions: Loss-of-control Eating, Obesity/Overweight
Sex: All
Ages: 18 Years – 64 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 16
Sponsor: Yale University
Location: Yale School of Medicine New Haven Connecticut
Summary
This study will test the effectiveness of lisdexamfetamine medication as a treatment for loss-of-control eating and weight following bariatric surgery. This is a controlled test of whether, amongst non-responders to acute treatments, lisdexamfetamine medication results in superior outcomes compared with placebo.
Eligibility Criteria
Inclusion Criteria:
* Be in the age range ≥18 years of age and \ 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 II 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.
* Is currently in active treatment for eating or weight loss.
* 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.
* Previous history of problems with LDX or other stimulants.
* Has a history of allergy or sensitivity to LDX or other stimulant medications.
* Current medication contraindicated with study medication.
* Any current psychostimulant use or any medication for ADHD.
* History or current alcohol or substance use disorder (smoking will not be exclusionary)
* Is currently taking MAOI medication, SSRI medication, or strong inhibitors of CYP2D6
Source: ClinicalTrials.gov (NCT04599504). StuddyBuddy aggregates publicly available trial information.