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Trial record 69 of 439 for:    Methylphenidate

The Effects of Methylphenidate on Energy Intake and Energy Expenditure (MPH)

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ClinicalTrials.gov Identifier: NCT02754258
Recruitment Status : Unknown
Verified August 2017 by Phillippe Robaey, Children's Hospital of Eastern Ontario.
Recruitment status was:  Recruiting
First Posted : April 28, 2016
Last Update Posted : August 3, 2017
Sponsor:
Collaborator:
University of Ottawa
Information provided by (Responsible Party):
Phillippe Robaey, Children's Hospital of Eastern Ontario

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.


Condition or disease Intervention/treatment Phase
Obesity Drug: MPH Drug: Placebo Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Methylphenidate on the Reduction of Food Energy Intake and on the Augmentation of Energy Expenditure
Study Start Date : January 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
60 day oral administration of sugar placebo twice per day before lunch and supper.
Drug: Placebo
60 days on oral placebo administered 2 times daily before lunch and supper
Other Name: Sugar Placebo

Experimental: Methylphenidate (MPH)
60 day oral administration of active study drug (methylphenidate) twice per day before lunch and supper.
Drug: MPH
60 days on oral methylphenidate administered 2 times daily before lunch and supper.
Other Name: pms-Methylphenidate




Primary Outcome Measures :
  1. 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). ]
    Participant will be offered a lunch buffet that includes items they indicate are preferred. They will be able to eat as much or as little as they choose.


Secondary Outcome Measures :
  1. Change in Energy Expenditure [ Time Frame: Measured three times over the course of 2 months (twice at baseline: once with and without study drug & once at final visit). ]
    Indirect calorimetry measure: participant lies supine on a bed while a neoprene mask is attached to their face. Expired breath is captured by the metabolic cart to assess resting energy expenditure and the thermic effect of feeding.

  2. Change in Body Weight [ Time Frame: Measured two times over the course of 2 months (once at baseline & once at final visit). ]
    Participant stands on a weight scale.

  3. Height [ Time Frame: Measured at baseline. ]
    Participant stands next to a stadiometer; height will be used to determine BMI at baseline.

  4. Height [ Time Frame: Measured at final visit; height will be used to determine BMI at the final visit. ]
    Participant stands next to a stadiometer

  5. Change in Body Mass Index [ Time Frame: Measured two times over the course of 2 months (once at baseline & once at final visit). ]
    This measure is a conglomerate of body weight (kg) divided by height (meters squared)

  6. Change in Impulsivity towards food and non-food reward as measured by reaction time on a computer task. [ Time Frame: Measured three times over the course of 2 months (twice at baseline: once with and without study drug & once at final visit). ]
    A "go/no-go"computer task that measures reaction time to food and non-food cues with simple button-presses on a keyboard.

  7. Change in Odour Detection Threshold measured with Sniffin' Sticks Odourized Pens [ Time Frame: Measured three times over the course of 2 months (twice at baseline: once with and without study drug & once at final visit). ]
    Odourized pens, called Sniffin Sticks, are used to measure odour detection threshold for a non-toxic odourant called n-butanol.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02754258


Contacts
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Contact: Jameason D Cameron, PhD 613-737-7600 ext 4103 jcameron@cheo.on.ca
Contact: Gary S Goldfield, PhD 613-737-7600 ext 3288 ggoldfield@cheo.on.ca

Locations
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Canada, Ontario
Children's Hospital Of Eastern Ontario Research Institute Recruiting
Ottawa, Ontario, Canada, K1H8L1
Contact: Children's Hospital Of E Ontario, PhD    6137377600 ext 4103    jcameron@cheo.on.ca   
University of Ottawa Recruiting
Ottawa, Ontario, Canada, K1N6N5
Contact: Jameason Cameron, PhD    16137377600 ext 4103    jcameron@cheo.on.ca   
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
University of Ottawa
Investigators
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Study Chair: Eric Doucet, PhD University of Ottawa
Principal Investigator: Philippe Robaey, MD, FRCPC Childrens Hospital of Eastern Ontario-Research Inst

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Responsible Party: Phillippe Robaey, Qualified Investigator, MD, PhD, FRCPC, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT02754258     History of Changes
Other Study ID Numbers: 15/10E
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We have not made a plan to make IPD available. We do plan on publishing the findings, but as per normal scientific reporting, with deidentified data.
Additional relevant MeSH terms:
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Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents