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Prevention of Cigarette Smoking in Attention Deficit Hyperactivity Disorder (ADHD) Youth With Concerta

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00181714
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : February 7, 2012
Last Update Posted : May 7, 2013
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition ADHD
Intervention Drug: methylphenidate HCl (Concerta)
Enrollment 203
Recruitment Details  
Pre-assignment Details  
Arm/Group Title OROS-Methylphenidate
Hide Arm/Group Description Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH.
Period Title: Signed Consent/Enrolled
Started 203
Completed 154
Not Completed 49
Period Title: Began Treatment With OROS-MPH
Started 154
Completed 30
Not Completed 124
Arm/Group Title OROS-Methylphenidate
Hide Arm/Group Description Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH.
Overall Number of Baseline Participants 154
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 154 participants
<=18 years
154
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 154 participants
15.3  (1.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 154 participants
Female
40
  26.0%
Male
114
  74.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 154 participants
154
1.Primary Outcome
Title Cigarette Smoking
Hide Description Cigarette smoking was assessed by youth self report using a modified version of the Fagerstrom Tolerance Questionnaire (FTQ)
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Clinical trial subjects included in this analysis included those adolescents who took at least one dose of OROS MPH following baseline assessment (N=154), with the last observation carried forward (LOCF) for subjects who did not complete the full study schedule of 24 months
Arm/Group Title OROS-Methylphenidate
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 154
Measure Type: Number
Unit of Measure: percent
7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title OROS-Methylphenidate
Hide Arm/Group Description Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH.
All-Cause Mortality
OROS-Methylphenidate
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
OROS-Methylphenidate
Affected / at Risk (%) # Events
Total   5/154 (3.25%)    
General disorders   
viral illness *  1/154 (0.65%)  2
Injury, poisoning and procedural complications   
leg fracture *  2/154 (1.30%)  2
unintentional carbon monoxide poisoning *  1/154 (0.65%)  1
Respiratory, thoracic and mediastinal disorders   
spontaneous pneumothorax *  1/154 (0.65%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.001%
OROS-Methylphenidate
Affected / at Risk (%) # Events
Total   45/154 (29.22%)    
Ear and labyrinth disorders   
ear pain *  3/154 (1.95%)  3
Gastrointestinal disorders   
diarrhea *  3/154 (1.95%)  3
nausea *  4/154 (2.60%)  4
stomach ache *  2/154 (1.30%)  2
vomiting *  2/154 (1.30%)  2
General disorders   
allergies *  3/154 (1.95%)  4
back pain *  1/154 (0.65%)  1
jumbled thoughts *  1/154 (0.65%)  1
chest pain *  2/154 (1.30%)  3
cold symptoms *  2/154 (1.30%)  3
congestion *  4/154 (2.60%)  4
cranky *  2/154 (1.30%)  3
decreased appetite *  19/154 (12.34%)  27
decreased energy *  3/154 (1.95%)  3
dizziness *  4/154 (2.60%)  5
dull *  1/154 (0.65%)  1
foot pain *  2/154 (1.30%)  2
headache *  14/154 (9.09%)  25
heart racing *  6/154 (3.90%)  8
hoarse voice *  1/154 (0.65%)  1
hot/cold flashes *  1/154 (0.65%)  1
hyper *  1/154 (0.65%)  1
inflamed adenoids *  1/154 (0.65%)  2
initial insomnia * 1  4/154 (2.60%)  6
insomnia *  7/154 (4.55%)  8
irritable *  3/154 (1.95%)  4
jittery *  2/154 (1.30%)  3
knee pain *  1/154 (0.65%)  2
lightheadedness *  2/154 (1.30%)  2
low interest *  1/154 (0.65%)  1
moody *  2/154 (1.30%)  2
nose bleed *  1/154 (0.65%)  1
orthodontic pain *  1/154 (0.65%)  2
otitis *  1/154 (0.65%)  1
phinorhea *  1/154 (0.65%)  1
rapid pulse *  1/154 (0.65%)  5
runny nose *  2/154 (1.30%)  2
sad *  1/154 (0.65%)  1
shoulder pain *  1/154 (0.65%)  1
sore throat *  4/154 (2.60%)  4
teary *  1/154 (0.65%)  1
tense *  1/154 (0.65%)  1
toothache *  1/154 (0.65%)  1
twisted ankle pain *  1/154 (0.65%)  1
weight loss *  1/154 (0.65%)  1
Infections and infestations   
dental infection *  1/154 (0.65%)  2
infected ingrown tonail *  1/154 (0.65%)  1
upper respiratory infection *  5/154 (3.25%)  8
Injury, poisoning and procedural complications   
deer tick bite *  1/154 (0.65%)  1
hand lesion *  1/154 (0.65%)  1
Musculoskeletal and connective tissue disorders   
TMJ *  1/154 (0.65%)  1
costosternal muscle strain *  1/154 (0.65%)  1
muscle aches *  1/154 (0.65%)  1
pain extension in bilateral arms/legs *  1/154 (0.65%)  1
Psychiatric disorders   
anxiety *  2/154 (1.30%)  2
Renal and urinary disorders   
increased urination *  1/154 (0.65%)  1
Reproductive system and breast disorders   
menstrual cramps *  1/154 (0.65%)  2
Respiratory, thoracic and mediastinal disorders   
asthma attack *  1/154 (0.65%)  1
cough *  3/154 (1.95%)  3
tight breathing *  1/154 (0.65%)  1
Skin and subcutaneous tissue disorders   
acne *  4/154 (2.60%)  8
rash (poison ivy) *  1/154 (0.65%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, insomnia
The main limitation of this report stems from its uncontrolled, open-label design. Thus, we cannot assert a causal relationship between lower smoking rates and OROS MPH prescription.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Paul Hammerness, MD
Organization: Massachusetts General Hospital
Phone: 617-503-1063
EMail: phammerness@partners.org
Layout table for additonal information
Responsible Party: Joseph Biederman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00181714    
Other Study ID Numbers: 2003-P-001313
First Submitted: September 13, 2005
First Posted: September 16, 2005
Results First Submitted: January 5, 2012
Results First Posted: February 7, 2012
Last Update Posted: May 7, 2013