Studying the Effects of Sibutramine on Eating Behavior
Information source: New York State Psychiatric Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: Sibutramine (Drug)
Phase: N/A
Status: Terminated
Sponsored by: New York State Psychiatric Institute Official(s) and/or principal investigator(s): Laurel Mayer, M.D., Principal Investigator, Affiliation: New York State Psychiatric Institute
Summary
Obesity is a major public health concern, and the search for useful pharmacologic
interventions is ongoing. This study aims to develop a comprehensive series of assessments
to directly assess eating behavior, cognitive functioning, and psychological functioning
under sibutramine and placebo conditions.
Clinical Details
Official title: Studying the Effects of Sibutramine on Eating Behavior
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
Primary outcome: weight loss (lbs)
Secondary outcome: caloric intake
Detailed description:
We will recruit 48 moderately obese men and women seeking weight-loss treatment to
participate in a 3-week, randomized, double-blind, cross-over trial of sibutramine 15mg or
placebo daily. At the end of weeks 1 and 3, subjects will be asked to participate in a
two-day/three-night stay in the Residential Laboratory or BSU of NYSPI for comprehensive
assessments. The major outcome variable will be the difference in total daily caloric intake
between sibutramine and placebo.
Assessments will concentrate on three main components of eating behavior: eating patterns,
psychological processing, and neurocognitive function. Eating behavior studies will examine
objective variables such as meal size, meal frequency, and subjective aspects of eating such
as hunger and fullness. Psychological studies will measure hedonics, including craving,
behavioral restraint, and impulsivity. Neurocognitive function assessment will gather
information about decision-making, such as the effects of distractors (food and non-food) on
task performance. Additionally, drawing from the field of behavioral neuroeconomics, tasks
that assess decision-making and the influence of irrational factors on decisions will be
assessed. Neuroimaging (fMRI) procedures will also be conducted, and will augment the
psychological and neurocognitive assessments by providing a window into the underlying
neural circuitry involved.
Following the double-blind phase, participants will be offered open treatment with
sibutramine for weight loss.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- moderately obese
- stable weight for a minimum of 3 months
- systolic blood pressure less than or equal to 140 mm Hg
- diastolic blood pressure less than or equal to 90 mm Hg
- pulse less than or equal to 95 beats per minute
- English language proficiency
Exclusion Criteria:
- on medications known to affect appetite, weight, or metabolism
- current or past history of: binge eating disorder, anorexia nervosa or bulimia
nervosa, major depression
- current or past evidence of psychosis, bipolar illness
- current or past history of alcohol or drug abuse or dependence
- known history of learning disorder or developmental disability
- current or past ADHD
- low platelet count
- current diabetes mellitus
- uncontrolled asthma, or controlled only with oral steroids
- hypothyroidism not adequately treated
- pregnancy, planning to become pregnant, or lactation within the previous 6 months
- history of neurological disorder or injury
- history of moderate or severe head injury
- waist circumference greater than 188 cm
- indwelling metallic object, non-removable metal jewelery, medicinal patch or recent
metallic ink tattoo
- pacemaker
- metallic implants
- medication patches
- significant claustrophobia
- color blindness
Locations and Contacts
New York State Psychiatric Institute, New York, New York 10032, United States
Additional Information
Columbia Center for Eating Disorders
Starting date: February 2009
Last updated: February 27, 2012
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