Trial Outcomes & Findings for Youth Smoking Cessation: Therapy +/- "The Patch" (NCT NCT00631020)
NCT ID: NCT00631020
Last Updated: 2015-04-22
Results Overview
Participants were offered optional nicotine replacement therapy (NRT). The number of participants that opted for NRT was measured.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
week 2
Results posted on
2015-04-22
Participant Flow
Participant milestones
| Measure |
CBME +/- NRT
6 weeks CBME with optional NRT for 4 weeks
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
CBME +/- NRT
6 weeks CBME with optional NRT for 4 weeks
|
|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Incarcerated
|
1
|
Baseline Characteristics
Youth Smoking Cessation: Therapy +/- "The Patch"
Baseline characteristics by cohort
| Measure |
CBME +/- NRT
n=34 Participants
6 weeks of once a week CBME with optional 4 weeks NRT
|
|---|---|
|
Age, Continuous
|
19 years
STANDARD_DEVIATION 1.7 • n=93 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: week 2Participants were offered optional nicotine replacement therapy (NRT). The number of participants that opted for NRT was measured.
Outcome measures
| Measure |
CBME +/- NRT
n=34 Participants
6 weeks CBME with optional 4 weeks NRT
|
|---|---|
|
Acceptance of Nicotine Replacement Therapy
|
26 participants
|
PRIMARY outcome
Timeframe: week 6Retention in trial is defined as completing the 6-week intervention (attended week6, yes/no)
Outcome measures
| Measure |
CBME +/- NRT
n=34 Participants
6 weeks CBME with optional 4 weeks NRT
|
|---|---|
|
Retention in Trial
|
26 participants
|
PRIMARY outcome
Timeframe: week 6, 12, 16 and 24The primary index of smoking behavior will be subject's self-report of smoking using a diary method for the past 7 days prior to the assessment. The subject self-report will be supplemented by: expired CO and by urine cotinine concentrations. Abstinence (yes/no) will be defined as no cigarettes during the past 7 days and an expired CO of \<=8 ppm.
Outcome measures
| Measure |
CBME +/- NRT
n=26 Participants
6 weeks CBME with optional 4 weeks NRT
|
|---|---|
|
7-day Smoking Abstinence at End of Treatment (Week 6) and at Follow-up Visits (Weeks 12, 16, 24)
Week 6 (n=26)
|
8 participants
|
|
7-day Smoking Abstinence at End of Treatment (Week 6) and at Follow-up Visits (Weeks 12, 16, 24)
Week 16 (n=23)
|
4 participants
|
|
7-day Smoking Abstinence at End of Treatment (Week 6) and at Follow-up Visits (Weeks 12, 16, 24)
Week 24 (n=23)
|
2 participants
|
|
7-day Smoking Abstinence at End of Treatment (Week 6) and at Follow-up Visits (Weeks 12, 16, 24)
Week 12 (n=25)
|
6 participants
|
SECONDARY outcome
Timeframe: Weeks 6, 12, 16 and 24Tobacco withdrawal symptoms were measured using the Minnesota Nicotine Withdrawal Scale (MNWS). Eight withdrawal symptoms are each rated for their severity on a scale from 0 (not present) to 4 (severe) for the past week and summed to calculate a total score at each time point, with a score range of 0-32. The average change from baseline for all participants at the specified time points were determined.
Outcome measures
| Measure |
CBME +/- NRT
n=26 Participants
6 weeks CBME with optional 4 weeks NRT
|
|---|---|
|
Changes in Tobacco Withdrawal Symptoms Compared to Baseline
Week 6 (n=26)
|
-5.6 units on a scale
Standard Deviation 7.3
|
|
Changes in Tobacco Withdrawal Symptoms Compared to Baseline
Week 12 (n=25)
|
-5.7 units on a scale
Standard Deviation 6.6
|
|
Changes in Tobacco Withdrawal Symptoms Compared to Baseline
Week 16 (n=23)
|
-3.5 units on a scale
Standard Deviation 6.8
|
|
Changes in Tobacco Withdrawal Symptoms Compared to Baseline
Week 24 (n=23)
|
-4.3 units on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Weeks 6, 12, 16 and 24Tobacco dependence was measured using the Cigarette Dependence Scale (CDS-12). The CDS-12 scale is a 12-item scale that assesses some components of formal diagnostic systems' (e.g., DSM-IV and ICD-10) definitions of dependence with an emphasis on compulsion to smoke, withdrawal, loss of control, time allocation, neglect of other activities, and persistence despite harm. Response choices are on a five-point Likert scale to measure dependence (low =1; high = 5), the total score is the sum of all 12 items with a score range of 12 - 60. The change in scores from baseline at each time point were measured.
Outcome measures
| Measure |
CBME +/- NRT
n=26 Participants
6 weeks CBME with optional 4 weeks NRT
|
|---|---|
|
Change in Tobacco Dependence Compared to Baseline
Week 6 (n=26)
|
-19 units on a scale
Standard Deviation 12
|
|
Change in Tobacco Dependence Compared to Baseline
Week 12 (n=25)
|
-14.3 units on a scale
Standard Deviation 12.9
|
|
Change in Tobacco Dependence Compared to Baseline
Week 16 (n=23)
|
-12.2 units on a scale
Standard Deviation 13
|
|
Change in Tobacco Dependence Compared to Baseline
Week 24 (n=23)
|
-8.8 units on a scale
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: Weeks 6, 12, 16 and 24Change from baseline self report of number of cigarettes per day compared to the past 7 days at each time point.
Outcome measures
| Measure |
CBME +/- NRT
n=26 Participants
6 weeks CBME with optional 4 weeks NRT
|
|---|---|
|
Change in Number of Cigarettes/Day During the Past 7-days Compared to Baseline
Week 6 (n=26)
|
3.1 cigarettes/day
Standard Deviation 4.6
|
|
Change in Number of Cigarettes/Day During the Past 7-days Compared to Baseline
Week 12 (n=25)
|
3.9 cigarettes/day
Standard Deviation 4.2
|
|
Change in Number of Cigarettes/Day During the Past 7-days Compared to Baseline
Week 16 (n=23)
|
3.4 cigarettes/day
Standard Deviation 4.2
|
|
Change in Number of Cigarettes/Day During the Past 7-days Compared to Baseline
Week 24 (n=23)
|
6.7 cigarettes/day
Standard Deviation 6.2
|
Adverse Events
CBME +/- NRT
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CBME +/- NRT
n=34 participants at risk
6 weeks CBME with optional 4 weeks NRT
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash-like reaction
|
20.6%
7/34 • Number of events 10
As a safety measure, participants will consult with the study physician or licensed nurse practitioner once a week about their general health. Any physical or clinical change or illness, whether or not it is considered study drug related, will be recorded on the medical record chart and adverse event case report form.
|
|
Psychiatric disorders
Insomnia
|
17.6%
6/34 • Number of events 7
As a safety measure, participants will consult with the study physician or licensed nurse practitioner once a week about their general health. Any physical or clinical change or illness, whether or not it is considered study drug related, will be recorded on the medical record chart and adverse event case report form.
|
|
Psychiatric disorders
Craving
|
11.8%
4/34 • Number of events 6
As a safety measure, participants will consult with the study physician or licensed nurse practitioner once a week about their general health. Any physical or clinical change or illness, whether or not it is considered study drug related, will be recorded on the medical record chart and adverse event case report form.
|
|
Gastrointestinal disorders
Nausea
|
8.8%
3/34 • Number of events 6
As a safety measure, participants will consult with the study physician or licensed nurse practitioner once a week about their general health. Any physical or clinical change or illness, whether or not it is considered study drug related, will be recorded on the medical record chart and adverse event case report form.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
11.8%
4/34 • Number of events 5
As a safety measure, participants will consult with the study physician or licensed nurse practitioner once a week about their general health. Any physical or clinical change or illness, whether or not it is considered study drug related, will be recorded on the medical record chart and adverse event case report form.
|
|
Nervous system disorders
Headache
|
11.8%
4/34 • Number of events 4
As a safety measure, participants will consult with the study physician or licensed nurse practitioner once a week about their general health. Any physical or clinical change or illness, whether or not it is considered study drug related, will be recorded on the medical record chart and adverse event case report form.
|
|
Psychiatric disorders
Irritable
|
11.8%
4/34 • Number of events 4
As a safety measure, participants will consult with the study physician or licensed nurse practitioner once a week about their general health. Any physical or clinical change or illness, whether or not it is considered study drug related, will be recorded on the medical record chart and adverse event case report form.
|
|
Respiratory, thoracic and mediastinal disorders
Cold symptoms
|
5.9%
2/34 • Number of events 3
As a safety measure, participants will consult with the study physician or licensed nurse practitioner once a week about their general health. Any physical or clinical change or illness, whether or not it is considered study drug related, will be recorded on the medical record chart and adverse event case report form.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.8%
3/34 • Number of events 3
As a safety measure, participants will consult with the study physician or licensed nurse practitioner once a week about their general health. Any physical or clinical change or illness, whether or not it is considered study drug related, will be recorded on the medical record chart and adverse event case report form.
|
|
Psychiatric disorders
Anhedonia
|
2.9%
1/34 • Number of events 1
As a safety measure, participants will consult with the study physician or licensed nurse practitioner once a week about their general health. Any physical or clinical change or illness, whether or not it is considered study drug related, will be recorded on the medical record chart and adverse event case report form.
|
|
Psychiatric disorders
Decreased concentration
|
2.9%
1/34 • Number of events 1
As a safety measure, participants will consult with the study physician or licensed nurse practitioner once a week about their general health. Any physical or clinical change or illness, whether or not it is considered study drug related, will be recorded on the medical record chart and adverse event case report form.
|
|
General disorders
Decreased energy
|
2.9%
1/34 • Number of events 1
As a safety measure, participants will consult with the study physician or licensed nurse practitioner once a week about their general health. Any physical or clinical change or illness, whether or not it is considered study drug related, will be recorded on the medical record chart and adverse event case report form.
|
|
Gastrointestinal disorders
Dental pain
|
2.9%
1/34 • Number of events 1
As a safety measure, participants will consult with the study physician or licensed nurse practitioner once a week about their general health. Any physical or clinical change or illness, whether or not it is considered study drug related, will be recorded on the medical record chart and adverse event case report form.
|
|
Nervous system disorders
Dizzy
|
2.9%
1/34 • Number of events 1
As a safety measure, participants will consult with the study physician or licensed nurse practitioner once a week about their general health. Any physical or clinical change or illness, whether or not it is considered study drug related, will be recorded on the medical record chart and adverse event case report form.
|
|
General disorders
Fatigue
|
2.9%
1/34 • Number of events 1
As a safety measure, participants will consult with the study physician or licensed nurse practitioner once a week about their general health. Any physical or clinical change or illness, whether or not it is considered study drug related, will be recorded on the medical record chart and adverse event case report form.
|
|
Gastrointestinal disorders
Indigestion
|
2.9%
1/34 • Number of events 1
As a safety measure, participants will consult with the study physician or licensed nurse practitioner once a week about their general health. Any physical or clinical change or illness, whether or not it is considered study drug related, will be recorded on the medical record chart and adverse event case report form.
|
|
Psychiatric disorders
Shaky
|
2.9%
1/34 • Number of events 1
As a safety measure, participants will consult with the study physician or licensed nurse practitioner once a week about their general health. Any physical or clinical change or illness, whether or not it is considered study drug related, will be recorded on the medical record chart and adverse event case report form.
|
|
Infections and infestations
Strep throat
|
2.9%
1/34 • Number of events 1
As a safety measure, participants will consult with the study physician or licensed nurse practitioner once a week about their general health. Any physical or clinical change or illness, whether or not it is considered study drug related, will be recorded on the medical record chart and adverse event case report form.
|
|
Psychiatric disorders
Stress
|
2.9%
1/34 • Number of events 1
As a safety measure, participants will consult with the study physician or licensed nurse practitioner once a week about their general health. Any physical or clinical change or illness, whether or not it is considered study drug related, will be recorded on the medical record chart and adverse event case report form.
|
|
Musculoskeletal and connective tissue disorders
Toe pain
|
2.9%
1/34 • Number of events 1
As a safety measure, participants will consult with the study physician or licensed nurse practitioner once a week about their general health. Any physical or clinical change or illness, whether or not it is considered study drug related, will be recorded on the medical record chart and adverse event case report form.
|
|
Infections and infestations
Tonsillar abscess
|
2.9%
1/34 • Number of events 1
As a safety measure, participants will consult with the study physician or licensed nurse practitioner once a week about their general health. Any physical or clinical change or illness, whether or not it is considered study drug related, will be recorded on the medical record chart and adverse event case report form.
|
|
Infections and infestations
Upper respiratory infection
|
2.9%
1/34 • Number of events 1
As a safety measure, participants will consult with the study physician or licensed nurse practitioner once a week about their general health. Any physical or clinical change or illness, whether or not it is considered study drug related, will be recorded on the medical record chart and adverse event case report form.
|
|
Psychiatric disorders
Vivid dreams
|
2.9%
1/34 • Number of events 1
As a safety measure, participants will consult with the study physician or licensed nurse practitioner once a week about their general health. Any physical or clinical change or illness, whether or not it is considered study drug related, will be recorded on the medical record chart and adverse event case report form.
|
Additional Information
Dr. Steven Shoptaw
UCLA Center for Health Promotion and Disease Prevention
Phone: 310-794-0619
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place