Trial Outcomes & Findings for Prevention of Cigarette Smoking in Attention Deficit Hyperactivity Disorder (ADHD) Youth With Concerta (NCT NCT00181714)
NCT ID: NCT00181714
Last Updated: 2013-05-07
Results Overview
Cigarette smoking was assessed by youth self report using a modified version of the Fagerstrom Tolerance Questionnaire (FTQ)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
203 participants
Primary outcome timeframe
24 months
Results posted on
2013-05-07
Participant Flow
Participant milestones
| Measure |
OROS-Methylphenidate
Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH.
|
|---|---|
|
Signed Consent/Enrolled
STARTED
|
203
|
|
Signed Consent/Enrolled
COMPLETED
|
154
|
|
Signed Consent/Enrolled
NOT COMPLETED
|
49
|
|
Began Treatment With OROS-MPH
STARTED
|
154
|
|
Began Treatment With OROS-MPH
COMPLETED
|
30
|
|
Began Treatment With OROS-MPH
NOT COMPLETED
|
124
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevention of Cigarette Smoking in Attention Deficit Hyperactivity Disorder (ADHD) Youth With Concerta
Baseline characteristics by cohort
| Measure |
OROS-Methylphenidate
n=154 Participants
Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH.
|
|---|---|
|
Age, Categorical
<=18 years
|
154 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
15.3 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
114 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
154 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: 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
Cigarette smoking was assessed by youth self report using a modified version of the Fagerstrom Tolerance Questionnaire (FTQ)
Outcome measures
| Measure |
OROS-Methylphenidate
n=154 Participants
|
|---|---|
|
Cigarette Smoking
|
7 percent
|
Adverse Events
OROS-Methylphenidate
Serious events: 5 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OROS-Methylphenidate
n=154 participants at risk
Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH.
|
|---|---|
|
Injury, poisoning and procedural complications
leg fracture
|
1.3%
2/154 • Number of events 2
|
|
General disorders
viral illness
|
0.65%
1/154 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
spontaneous pneumothorax
|
0.65%
1/154 • Number of events 1
|
|
Injury, poisoning and procedural complications
unintentional carbon monoxide poisoning
|
0.65%
1/154 • Number of events 1
|
Other adverse events
| Measure |
OROS-Methylphenidate
n=154 participants at risk
Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
TMJ
|
0.65%
1/154 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
acne
|
2.6%
4/154 • Number of events 8
|
|
General disorders
allergies
|
1.9%
3/154 • Number of events 4
|
|
Psychiatric disorders
anxiety
|
1.3%
2/154 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
asthma attack
|
0.65%
1/154 • Number of events 1
|
|
General disorders
back pain
|
0.65%
1/154 • Number of events 1
|
|
General disorders
jumbled thoughts
|
0.65%
1/154 • Number of events 1
|
|
General disorders
chest pain
|
1.3%
2/154 • Number of events 3
|
|
General disorders
cold symptoms
|
1.3%
2/154 • Number of events 3
|
|
General disorders
congestion
|
2.6%
4/154 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
costosternal muscle strain
|
0.65%
1/154 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
1.9%
3/154 • Number of events 3
|
|
General disorders
cranky
|
1.3%
2/154 • Number of events 3
|
|
General disorders
decreased appetite
|
12.3%
19/154 • Number of events 27
|
|
General disorders
decreased energy
|
1.9%
3/154 • Number of events 3
|
|
Injury, poisoning and procedural complications
deer tick bite
|
0.65%
1/154 • Number of events 1
|
|
Infections and infestations
dental infection
|
0.65%
1/154 • Number of events 2
|
|
Gastrointestinal disorders
diarrhea
|
1.9%
3/154 • Number of events 3
|
|
General disorders
dizziness
|
2.6%
4/154 • Number of events 5
|
|
General disorders
dull
|
0.65%
1/154 • Number of events 1
|
|
Ear and labyrinth disorders
ear pain
|
1.9%
3/154 • Number of events 3
|
|
General disorders
foot pain
|
1.3%
2/154 • Number of events 2
|
|
Injury, poisoning and procedural complications
hand lesion
|
0.65%
1/154 • Number of events 1
|
|
General disorders
headache
|
9.1%
14/154 • Number of events 25
|
|
General disorders
heart racing
|
3.9%
6/154 • Number of events 8
|
|
General disorders
hoarse voice
|
0.65%
1/154 • Number of events 1
|
|
General disorders
hot/cold flashes
|
0.65%
1/154 • Number of events 1
|
|
General disorders
hyper
|
0.65%
1/154 • Number of events 1
|
|
Renal and urinary disorders
increased urination
|
0.65%
1/154 • Number of events 1
|
|
Infections and infestations
infected ingrown tonail
|
0.65%
1/154 • Number of events 1
|
|
General disorders
inflamed adenoids
|
0.65%
1/154 • Number of events 2
|
|
General disorders
initial insomnia
|
2.6%
4/154 • Number of events 6
|
|
General disorders
insomnia
|
4.5%
7/154 • Number of events 8
|
|
General disorders
irritable
|
1.9%
3/154 • Number of events 4
|
|
General disorders
jittery
|
1.3%
2/154 • Number of events 3
|
|
General disorders
knee pain
|
0.65%
1/154 • Number of events 2
|
|
General disorders
lightheadedness
|
1.3%
2/154 • Number of events 2
|
|
General disorders
low interest
|
0.65%
1/154 • Number of events 1
|
|
Reproductive system and breast disorders
menstrual cramps
|
0.65%
1/154 • Number of events 2
|
|
General disorders
moody
|
1.3%
2/154 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
muscle aches
|
0.65%
1/154 • Number of events 1
|
|
Gastrointestinal disorders
nausea
|
2.6%
4/154 • Number of events 4
|
|
General disorders
nose bleed
|
0.65%
1/154 • Number of events 1
|
|
General disorders
orthodontic pain
|
0.65%
1/154 • Number of events 2
|
|
General disorders
otitis
|
0.65%
1/154 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
pain extension in bilateral arms/legs
|
0.65%
1/154 • Number of events 1
|
|
General disorders
phinorhea
|
0.65%
1/154 • Number of events 1
|
|
General disorders
rapid pulse
|
0.65%
1/154 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
rash (poison ivy)
|
0.65%
1/154 • Number of events 1
|
|
General disorders
runny nose
|
1.3%
2/154 • Number of events 2
|
|
General disorders
sad
|
0.65%
1/154 • Number of events 1
|
|
General disorders
shoulder pain
|
0.65%
1/154 • Number of events 1
|
|
General disorders
sore throat
|
2.6%
4/154 • Number of events 4
|
|
Gastrointestinal disorders
stomach ache
|
1.3%
2/154 • Number of events 2
|
|
General disorders
teary
|
0.65%
1/154 • Number of events 1
|
|
General disorders
tense
|
0.65%
1/154 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
tight breathing
|
0.65%
1/154 • Number of events 1
|
|
General disorders
toothache
|
0.65%
1/154 • Number of events 1
|
|
General disorders
twisted ankle pain
|
0.65%
1/154 • Number of events 1
|
|
Infections and infestations
upper respiratory infection
|
3.2%
5/154 • Number of events 8
|
|
Gastrointestinal disorders
vomiting
|
1.3%
2/154 • Number of events 2
|
|
General disorders
weight loss
|
0.65%
1/154 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place