The Effects of Methylphenidate on Energy Intake and Energy Expenditure

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The Problem: Obesity is one of the leading causes of chronic disease and death. The efficacy of diet and exercise to sustain weight loss over the long term is weak. While pharmacotherapy is more effective than behavior intervention in maintaining weight loss the effects are often not sufficient to achieve optimal health benefits. Current drug treatments may be sub-optimal because they do not directly target the rewarding value of food, drive to eat, food liking, and impulsivity for eating energy dense snack foods, all of which influences both quantity and quality of food intake and impacts adherence needed to maintain weight loss.

The Solution: The limitations in current anti-obesity agents are potentially addressed by Methylphenidate (MPH). We showed that MPH reduces food intake, dietary fat intake, hunger and food reward, as increase resting energy expenditure in obese and non-obese adults;however, no controlled field trials have been conducted in obese individuals without ADHD.

Objectives/Hypotheses: Primary: To test the effects of MPH on energy intake in obese men and women. Secondary: to examine the effects of MPH on energy expenditure, body weight, impulsivity, food reward, and olfaction. The investigators predict that compared to placebo, MPH will show reduced appetite, along with reduced impulsivity, food reward, and smell function.

Deliverable: This study may be the first to establish the short-term efficacy and safety of using MPH for weight loss, and if successful, data will inform a larger trial that can potentially identify MPH as a novel therapeutic agent for treating obesity and related chronic diseases in a predisposed population.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Children's Hospital of Eastern Ontario
• Collaborator: University of Ottawa
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• males and females 16 to 40 years old

• BMI in the obese category (above 29.9kg/m2)

• willing to comply with procedures, and sign informed consent forms

• able to swallow a placebo pill that will be used in the study (same size as study drug)

Exclusion Criteria:

• smoker (the main outcome is energy intake and smoking is known to impact appetite)

• known serious food allergies, including lactose

• history of previous MPH use or allergy to MPH

• history of ADHD or current diagnosis of an axis 1 psychiatric disorder (e.g., depression, panic disorder, schizophrenia) as measured by self-report, the Wender-Utah Rating Scale52-54 and the Beck Depression Inventory

• current use of antidepressants, thyroid medication, or any medication that could affect appetite

• high blood pressure

• pre-existing cardiovascular disorders including uncontrolled hypertension, angina pectoris, arterial occlusive disease, heart failure, cardiomypathies, myocardial infarction, and cardiac arrhythmia

• diabetes

• excessive use of alcohol or alcoholism, or current addictions to opiates, cocaine or stimulants as measured by the Drug Abuse Screening Test;

• not a restrained eater based on cut-score (11 or higher) on Three Factor Eating Questionnaire56

• glaucoma

• personal or family history of seizure disorders

• currently taking MAO inhibitors, pressor agents, coumarin, anticonvulsants, phenylbutazone, or tricyclic antidepressants

• history of thyroid disease

• personal or family history of motor tics or Tourettes's Syndrome

• not pregnant, as determined by commercially available pregnancy test taken by female participants prior to test dose of MPH.

• after the test dose of MPH, systolic blood pressure exceeding baseline reading by 20mmHg, diastolic blood pressure exceeding the baseline reading by 10mmHg, BP > 160/100, or resting pulse increased by 20 beats/minute from the baseline.