Recruiting
Phase 3

Methylphenidate

Sponsor:

Children's Hospital of Eastern Ontario

Code:

NCT02754258

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 16 - 40

Healthy Volunteers: Accepted

Interventions

MPH

Placebo

Study Details

Brief 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.

Conditions

Obesity

Study ID

NCT02754258

Start date

Jan, 2017

Status verified date

Aug, 2017

Completion date

Dec, 2018

Anticipated

Primary completion date

Aug, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 40

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

60 day oral administration of sugar placebo twice per day before lunch and supper.

experimental: Methylphenidate (MPH)

60 day oral administration of active study drug (methylphenidate) twice per day before lunch and supper.

Interventions

MPH

60 days on oral methylphenidate administered 2 times daily before lunch and supper.

Placebo

60 days on oral placebo administered 2 times daily before lunch and supper

Primary outcome measure

  • Change in Energy Intake [ Time Frame: Measured three times over the course of 2 months (twice at baseline: once with and without study drug & once at final visit). ]

Central Contacts and Locations

Central contacts

Jameason D Cameron, PhD

613-737-7600jcameron@cheo.on.ca

Locations

Children's Hospital Of Eastern Ontario Research Institute

Recruiting

Ottawa, Ontario, Canada, K1H8L1

Contacts

Children's Hospital Of E Ontario, PhD

6137377600jcameron@cheo.on.ca

University of Ottawa

Recruiting

Ottawa, Ontario, Canada, K1N6N5

Contacts

Jameason Cameron, PhD

16137377600jcameron@cheo.on.ca

More Information

Sponsor

Children's Hospital of Eastern Ontario

Last update posted

Aug 3, 2017

Last verified

Aug, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital of Eastern Ontario on 2017-08-03.