Trial Outcomes & Findings for Use of Varenicline for 4-weeks Prior to Quitting (NCT NCT00789074)
NCT ID: NCT00789074
Last Updated: 2013-12-12
Results Overview
The scale measures tobacco withdrawal symptoms (depressed, irritable, restless, hungry, poor concentration, slept worse than usual) on 5-point scales from Not at all (rated as 1) to Extremely (rated as 5). It also asks 'How much of the time have you felt the urge to smoke in the last week? and 'How strong have these urges been?'; both rated on 6-point scales with higher numbers=higher craving.
COMPLETED
PHASE3
101 participants
24 hours and 7 days after quit date (week 4)
2013-12-12
Participant Flow
Participant milestones
| Measure |
Varenicline Pre-treatmemt
Participants will use varenicline (1mg BD) 4-weeks prior to quitting
|
Placebo
Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
48
|
|
Overall Study
COMPLETED
|
42
|
35
|
|
Overall Study
NOT COMPLETED
|
11
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Varenicline for 4-weeks Prior to Quitting
Baseline characteristics by cohort
| Measure |
Varenicline Pre-treatmemt
n=53 Participants
Participants will use varenicline (1mg BD) 4-weeks prior to quitting
|
Placebo
n=48 Participants
Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age Continuous
|
45.91 years
STANDARD_DEVIATION 11.439 • n=5 Participants
|
45.29 years
STANDARD_DEVIATION 10.941 • n=7 Participants
|
45.61 years
STANDARD_DEVIATION 11.153 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
53 participants
n=5 Participants
|
48 participants
n=7 Participants
|
101 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours and 7 days after quit date (week 4)Population: Were abstinent and provided data at 24 hours post quit date
The scale measures tobacco withdrawal symptoms (depressed, irritable, restless, hungry, poor concentration, slept worse than usual) on 5-point scales from Not at all (rated as 1) to Extremely (rated as 5). It also asks 'How much of the time have you felt the urge to smoke in the last week? and 'How strong have these urges been?'; both rated on 6-point scales with higher numbers=higher craving.
Outcome measures
| Measure |
Varenicline
n=34 Participants
|
Placebo
n=29 Participants
|
|---|---|---|
|
Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale
|
2.47 units on a scale
Standard Deviation 1.13
|
2.88 units on a scale
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: Baseline - week 8Population: Participants that provided data at all time points
Carbon monoxide concentration is measured in particles per million. It indicates smoke intake. CO was measured at each contact to monitor changes in smoke intake and differences between the study arms.
Outcome measures
| Measure |
Varenicline
n=47 Participants
|
Placebo
n=40 Participants
|
|---|---|---|
|
Change in Pre-quit End-expired Carbon Monoxide Reading (CO)
|
-14.85 ppm
Standard Deviation 11.08
|
-7.68 ppm
Standard Deviation 10.34
|
SECONDARY outcome
Timeframe: Weeks 1-4 (the first 4-weeks after first medication dose)Population: All participants that provided data at all time points
Differences in baseline cotinine levels were compared with cotinine levels measured 4 weeks after taking the first medication dose.
Outcome measures
| Measure |
Varenicline
n=47 Participants
|
Placebo
n=41 Participants
|
|---|---|---|
|
Change in Pre-quit Cotinine Levels
|
-184.69 ng/ml
Standard Deviation 156.02
|
-44.73 ng/ml
Standard Deviation 114.56
|
SECONDARY outcome
Timeframe: Baseline - week 4Population: Participants who provided ratings of cigarette satisfaction at each visit
Satisfaction measured on a scale of 1-5; "Have you found your cigarettes more or less enjoyable than usual in the last week?" 1= much more and 5 = much less
Outcome measures
| Measure |
Varenicline
n=40 Participants
|
Placebo
n=38 Participants
|
|---|---|---|
|
Change in Pre-quit Ratings of Cigarette Satisfaction
|
-1.48 units on a scale
Standard Deviation 1.66
|
-0.842 units on a scale
Standard Deviation 1.26
|
SECONDARY outcome
Timeframe: Baseline - week 4Population: All participants that provided data at each session
Participants reported average number of cigarettes smoked per day every week throughout the four week pre-quit period.
Outcome measures
| Measure |
Varenicline
n=46 Participants
|
Placebo
n=40 Participants
|
|---|---|---|
|
Change in Pre-quit Cigarette Consumption
|
-9.78 Cigarettes consumed per day
Standard Deviation 9.67
|
-5.68 Cigarettes consumed per day
Standard Deviation 7.29
|
SECONDARY outcome
Timeframe: Week 4 - 8Population: Participants who were abstinent at 1 week and provided data on withdrawal symptoms
Change in the Mood and Physical Symptoms Scale (MPSS)\*, scores of urges to smoke and cigarette withdrawal symptoms throughout the first four weeks of abstinence (measured weekly from weeks 4-8). \* The MPSS measures cigarette withdrawal symptoms. The scale is 1-5, 1 being not at all and 5 being extremely (depressed, irritable, restless, hungry, poor concentration, slept worse than usual).
Outcome measures
| Measure |
Varenicline
n=35 Participants
|
Placebo
n=25 Participants
|
|---|---|---|
|
Change in MPSS Scores of Urges to Smoke and Cigarette Withdrawal Symptoms Throughout the First Four Weeks of Abstinence
|
0.15 Scores on a scale
Standard Deviation 0.68
|
0.15 Scores on a scale
Standard Deviation 0.53
|
Adverse Events
Varenicline Pre-treatmemt
Placebo
Serious adverse events
| Measure |
Varenicline Pre-treatmemt
n=53 participants at risk
Participants will use varenicline (1mg BD) 4-weeks prior to quitting
|
Placebo
n=48 participants at risk
Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
|
|---|---|---|
|
Cardiac disorders
Acute Myocardial infarction
|
1.9%
1/53 • Number of events 1
|
0.00%
0/48
|
|
Cardiac disorders
Musculoskeletal chest pain
|
0.00%
0/53
|
2.1%
1/48 • Number of events 1
|
Other adverse events
| Measure |
Varenicline Pre-treatmemt
n=53 participants at risk
Participants will use varenicline (1mg BD) 4-weeks prior to quitting
|
Placebo
n=48 participants at risk
Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
64.2%
34/53 • Number of events 34
|
45.8%
22/48 • Number of events 22
|
|
Psychiatric disorders
Abnormal dreams
|
26.4%
14/53 • Number of events 14
|
14.6%
7/48 • Number of events 7
|
|
General disorders
Headache
|
22.6%
12/53 • Number of events 12
|
14.6%
7/48 • Number of events 7
|
|
Psychiatric disorders
Sleep disturbance
|
18.9%
10/53 • Number of events 10
|
12.5%
6/48 • Number of events 6
|
|
Gastrointestinal disorders
Constipation
|
13.2%
7/53 • Number of events 7
|
2.1%
1/48 • Number of events 1
|
|
General disorders
Drowsiness
|
11.3%
6/53 • Number of events 6
|
4.2%
2/48 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
11.3%
6/53 • Number of events 6
|
14.6%
7/48 • Number of events 7
|
|
Gastrointestinal disorders
Abdominal pain
|
9.4%
5/53 • Number of events 5
|
8.3%
4/48 • Number of events 4
|
|
General disorders
Sweating
|
9.4%
5/53 • Number of events 5
|
0.00%
0/48
|
|
Psychiatric disorders
Depression
|
7.5%
4/53 • Number of events 4
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
7.5%
4/53 • Number of events 4
|
4.2%
2/48 • Number of events 2
|
|
Nervous system disorders
Fatigue
|
7.5%
4/53 • Number of events 4
|
6.2%
3/48 • Number of events 3
|
|
Nervous system disorders
Light headedness
|
7.5%
4/53 • Number of events 4
|
0.00%
0/48
|
|
Musculoskeletal and connective tissue disorders
Muscularskeletal pain
|
7.5%
4/53 • Number of events 4
|
6.2%
3/48 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
3/53 • Number of events 3
|
0.00%
0/48
|
|
Respiratory, thoracic and mediastinal disorders
Flu like symptoms
|
5.7%
3/53 • Number of events 3
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
Mouth ulceration
|
5.7%
3/53 • Number of events 3
|
2.1%
1/48 • Number of events 1
|
|
General disorders
Poor concentration
|
5.7%
3/53 • Number of events 3
|
2.1%
1/48 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin irritation/rash
|
5.7%
3/53 • Number of events 3
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
3/53 • Number of events 3
|
4.2%
2/48 • Number of events 2
|
|
General disorders
Bleeding gums
|
1.9%
1/53 • Number of events 1
|
6.2%
3/48 • Number of events 3
|
|
General disorders
Chest pain - not specified
|
1.9%
1/53 • Number of events 1
|
6.2%
3/48 • Number of events 3
|
Additional Information
Professor Peter Hajek
Queen Mary University of London
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place