Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000138482
Ethics application status
Approved
Date submitted
9/01/2007
Date registered
21/02/2007
Date last updated
21/02/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigation of the effect of a single dose of stimulant medication (dexamphetamine 10mg or methylphenidate 20mg) on appetite and on fasting and postprandial levels of insulin, glucose, leptin and ghrelin in healthy adult volunteers.
Scientific title
Investigation of the effect of a single dose of stimulant medication (dexamphetamine 10mg or methylphenidate 20mg) on appetite and on fasting and postprandial levels of insulin, glucose, leptin and ghrelin in healthy adult volunteers.
Universal Trial Number (UTN)
Trial acronym
Stimulant Growth Study: pilot study - adults
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Appetite suppression on stimulant medication. This is the presumed reason for the weight loss that usually occurs when children with attention deficit hyperactivity disorder (ADHD) are treated with dexamphetamine or methylphenidate. 1631 0
Healthy adult volunteers. 1632 0
Condition category
Condition code
Mental Health 1739 1739 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Double blind randomised placebo controlled trial investigating the effect of a single dose of stimulant medication (dexamphetamine 10mg or methylphenidate 20mg) given orally to fasted healthy adult volunteers. Each subject tested with medication and placebo (calcium carbonate) to serve as their own control. Minimum wash out period 4 days.
Intervention code [1] 1543 0
Treatment: Drugs
Comparator / control treatment
Placebo (calcium carbonate)
Control group
Placebo

Outcomes
Primary outcome [1] 2420 0
Insulin levels
Timepoint [1] 2420 0
At time 0 (fasted) and at 3 hours (after food).
Primary outcome [2] 2421 0
Glucose levels
Timepoint [2] 2421 0
At time 0 (fasted) and at 3 hours (after food).
Primary outcome [3] 2422 0
Leptin levels
Timepoint [3] 2422 0
At time 0 (fasted) and at 3 hours (after food).
Primary outcome [4] 2423 0
Ghrelin levels
Timepoint [4] 2423 0
At time 0 (fasted) and at 3 hours (after food).
Primary outcome [5] 2424 0
Amount of food consumed
Timepoint [5] 2424 0
At 1.5 - 2 hours
Primary outcome [6] 2425 0
Effect of medication on performance of auditory vigilance test
Timepoint [6] 2425 0
At 2 - 3.5 hours
Secondary outcome [1] 4193 0
Subjective effect of medication on appetite
Timepoint [1] 4193 0
At 0, 1, 2 and 3 hours

Eligibility
Key inclusion criteria
Fit and healthy
Minimum age
17 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current treament of medical condition, previous regular use of stimulant medication, history of substance abuse, BMI>30.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects recruited by poster and personal contact. Enrolled if willing to participate and suitable. Subjects randomised to methylphenidate or dexamphetamine, further randomised to treatment first or placebo first. Medication given double blind in identical capsule. Allocation: list of names of participants provided to pharmacy, medication dispensed in identical packaging and identified with each subject's name. Allocation concealed from subject and assessors.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
12 subjects recruited, allocated into matched pairs matched by age, sex and BMI, one of each pair randomised to dexamphetamine and the other to methylphenidate using simple randomisation procedure (coin tossing). Further randomised into medication first or placebo first using simple randomisation procedure (coin tossing).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
subjects, clinicians and assessors blinded.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1889 0
Charities/Societies/Foundations
Name [1] 1889 0
Australian Women & Children’s Research Foundation
Country [1] 1889 0
Australia
Primary sponsor type
Individual
Name
Chief investigator Dr Alison Poulton
Address
Country
Secondary sponsor category [1] 1708 0
None
Name [1] 1708 0
nil
Address [1] 1708 0
Country [1] 1708 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3514 0
Nepean Clinical School
Ethics committee address [1] 3514 0
Ethics committee country [1] 3514 0
Australia
Date submitted for ethics approval [1] 3514 0
Approval date [1] 3514 0
09/10/2006
Ethics approval number [1] 3514 0
05/037

Summary
Brief summary
Stimulant medication can be associated with slowing of growth in children with attention deficit hyperactivity disorder (ADHD), possibly by appetite suppression mediated by hormones such as leptin and ghrelin. Twelve healthy adult volunteers will have fasting blood tests for leptin, ghrelin, insulin and glucose, with these tests repeated after a meal. This will be done twice, once on medication (dexamphetamine or methylphenidate) and once on placebo. The effect of medication on food intake and alertness will be tested, together with subjects’ assessments of appetite and medication side effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27477 0
Address 27477 0
Country 27477 0
Phone 27477 0
Fax 27477 0
Email 27477 0
Contact person for public queries
Name 10732 0
Dr Alison Poulton
Address 10732 0
Nepean Clinical School
University of Sydney
Country 10732 0
Australia
Phone 10732 0
0247342000
Fax 10732 0
Email 10732 0
[email protected]
Contact person for scientific queries
Name 1660 0
Dr Alison Poulton
Address 1660 0
Nepean Clinical School
University of Sydney
Country 1660 0
Australia
Phone 1660 0
0247342000
Fax 1660 0
Email 1660 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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