Loss-of-control Eating, Obesity/Overweight
Conditions
Brief 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.
Interventions
DRUGLisdexamfetamine Dimesylate (Medication)
Medication will be taken daily in pill form.
OTHERPlacebo
Placebo will be inactive and taken daily in pill form.
Sponsors
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Be in the age range ≥18 years of age and \<65 years of age. * Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy * Approximately ten months post-surgery * Experienced regular loss of control eating about six months after bariatric surgery, and were considered treatment non-responders to a four-month treatment trial of medication and/or BWL * Be an otherwise healthy subject without uncontrolled medical problems, as determined by the study physician and medical co-investigators (physical examination, laboratory studies). * Read, comprehend, and write English at a sufficient level to complete study-related materials. * Provide a signed and dated written informed consent prior to study participation. * Be available for participation in the study for up to 15 months (3-month treatment plus 12-month follow up).
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 using other medications for weight loss. * 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Loss-of-Control Eating Frequency | At the end of 12-week treatment | Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month. |
| Percent Weight Change | From baseline at study enrollment to after the 12-week treatment | Percent weight loss is calculated based on change from pre-treatment to post-treatment at 3 months. Negative values indicate weight loss. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCarlos Grilo, PhD
Yale University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 50.19 years STANDARD_DEVIATION 9.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 7 |
| other Total, other adverse events | 8 / 9 | 3 / 7 |
| serious Total, serious adverse events | 0 / 9 | 0 / 7 |
Outcome results
None listed