Smoking Cessation, Tobacco Dependence
Conditions
Keywords
Smoking cessation, Tobacco dependence, Varenicline, Preloading
Brief summary
Varenicline (Champix) is a relatively new medicine that is effective in helping people to quit smoking. It is normally started 1-week before stopping smoking and used for up to 12-24 weeks. We are trying to find out if using varenicline for an extended time (4-weeks) before stopping smoking is better than the standard 1-week of use prior to stopping. The study will recruit 100 smokers who want to stop. They will be randomly allocated to receive varenicline(4-weeks) or placebo (3-weeks followed by 1-week of active treatment as indicated by standard prescribing practice), followed by a 12-week open label treatment period where all participants will receive varenicline.
Interventions
DRUGVarenicline
Varenicline 1mg twice daily
DRUGPlacebo
Placebo 1mg BD
Sponsors
Queen Mary University of London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Smokers seeking treatment * Aged 18 and over * Consenting to take part in the trial
Exclusion criteria
* Pregnant or breastfeeding * End-stage renal disease * Used varenicline in the past 6 months * Unable to fill in questionnaires in English * Current psychiatric illness * Current serious illness including uncontrolled hypertension and recent cardiac event * Sensitivity to varenicline currently enrolled in other research projects.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale | 24 hours and 7 days after quit date (week 4) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pre-quit End-expired Carbon Monoxide Reading (CO) | Baseline - week 8 | 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. |
| Change in Pre-quit Cotinine Levels | Weeks 1-4 (the first 4-weeks after first medication dose) | Differences in baseline cotinine levels were compared with cotinine levels measured 4 weeks after taking the first medication dose. |
| Change in Pre-quit Ratings of Cigarette Satisfaction | Baseline - week 4 | 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 |
| Change in Pre-quit Cigarette Consumption | Baseline - week 4 | Participants reported average number of cigarettes smoked per day every week throughout the four week pre-quit period. |
| Change in MPSS Scores of Urges to Smoke and Cigarette Withdrawal Symptoms Throughout the First Four Weeks of Abstinence | Week 4 - 8 | 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). |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Varenicline Pre-treatmemt Participants will use varenicline (1mg BD) 4-weeks prior to quitting | 53 |
| Placebo Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting | 48 |
| Total | 101 |
Baseline characteristics
| Characteristic | Placebo | Varenicline Pre-treatmemt | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 4 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants | 49 Participants | 96 Participants |
| Age Continuous | 45.29 years STANDARD_DEVIATION 10.941 | 45.91 years STANDARD_DEVIATION 11.439 | 45.61 years STANDARD_DEVIATION 11.153 |
| Region of Enrollment United Kingdom | 48 participants | 53 participants | 101 participants |
| Sex: Female, Male Female | 17 Participants | 19 Participants | 36 Participants |
| Sex: Female, Male Male | 31 Participants | 34 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 34 / 53 | 22 / 48 |
| serious Total, serious adverse events | 1 / 53 | 1 / 48 |
Outcome results
Primary
Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale
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.
Time frame: 24 hours and 7 days after quit date (week 4)
Population: Were abstinent and provided data at 24 hours post quit date
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Varenicline | 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 |
| Placebo | Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale | 2.88 units on a scale | Standard Deviation 1.15 |
p-value: 0.14ANOVA
Secondary
Change in MPSS Scores of Urges to Smoke and Cigarette Withdrawal Symptoms Throughout the First Four Weeks of Abstinence
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).
Time frame: Week 4 - 8
Population: Participants who were abstinent at 1 week and provided data on withdrawal symptoms
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Varenicline | 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 |
| Placebo | 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 0.53 |
p-value: 0.97ANOVA
Secondary
Change in Pre-quit Cigarette Consumption
Participants reported average number of cigarettes smoked per day every week throughout the four week pre-quit period.
Time frame: Baseline - week 4
Population: All participants that provided data at each session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Varenicline | Change in Pre-quit Cigarette Consumption | -9.78 Cigarettes consumed per day | Standard Deviation 9.67 |
| Placebo | Change in Pre-quit Cigarette Consumption | -5.68 Cigarettes consumed per day | Standard Deviation 7.29 |
p-value: 0.02ANOVA
Secondary
Change in Pre-quit Cotinine Levels
Differences in baseline cotinine levels were compared with cotinine levels measured 4 weeks after taking the first medication dose.
Time frame: Weeks 1-4 (the first 4-weeks after first medication dose)
Population: All participants that provided data at all time points
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Varenicline | Change in Pre-quit Cotinine Levels | -184.69 ng/ml | Standard Deviation 156.02 |
| Placebo | Change in Pre-quit Cotinine Levels | -44.73 ng/ml | Standard Deviation 114.56 |
p-value: <0.001ANOVA
Secondary
Change in Pre-quit End-expired Carbon Monoxide Reading (CO)
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.
Time frame: Baseline - week 8
Population: Participants that provided data at all time points
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Varenicline | Change in Pre-quit End-expired Carbon Monoxide Reading (CO) | -14.85 ppm | Standard Deviation 11.08 |
| Placebo | Change in Pre-quit End-expired Carbon Monoxide Reading (CO) | -7.68 ppm | Standard Deviation 10.34 |
p-value: <0.001ANOVA
Secondary
Change in Pre-quit Ratings of Cigarette Satisfaction
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
Time frame: Baseline - week 4
Population: Participants who provided ratings of cigarette satisfaction at each visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Varenicline | Change in Pre-quit Ratings of Cigarette Satisfaction | -1.48 units on a scale | Standard Deviation 1.66 |
| Placebo | Change in Pre-quit Ratings of Cigarette Satisfaction | -0.842 units on a scale | Standard Deviation 1.26 |
p-value: <0.04ANOVA