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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Varenicline pre-treatmemt | Experimental | Participants will use varenicline (1mg BD) 4-weeks prior to quitting |
|
| Placebo | Placebo Comparator | Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline | Drug | Varenicline 1mg twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours and 7 days after quit date (week 4) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline - week 8 |
| Change in Pre-quit Cotinine Levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Al-Rehan A A Dhanji, MB BS BSc MRCP | Queen Mary University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tobacco Dependence Research and Treatment Unit | London | E1 2JH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37142273 | Derived | Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8. | |
| 21518946 | Derived | Hajek P, McRobbie HJ, Myers KE, Stapleton J, Dhanji AR. Use of varenicline for 4 weeks before quitting smoking: decrease in ad lib smoking and increase in smoking cessation rates. Arch Intern Med. 2011 Apr 25;171(8):770-7. doi: 10.1001/archinternmed.2011.138. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Varenicline Pre-treatmemt | Participants will use varenicline (1mg BD) 4-weeks prior to quitting |
| FG001 | Placebo | Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Varenicline Pre-treatmemt | Participants will use varenicline (1mg BD) 4-weeks prior to quitting |
| BG001 | Placebo | Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Were abstinent and provided data at 24 hours post quit date | Posted | Mean | Standard Deviation | units on a scale | 24 hours and 7 days after quit date (week 4) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Varenicline Pre-treatmemt | Participants will use varenicline (1mg BD) 4-weeks prior to quitting |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Peter Hajek | Queen Mary University of London | +44 207 882 8231 | p.hajek@qmul.ac.uk |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Placebo 1mg BD |
|
Differences in baseline cotinine levels were compared with cotinine levels measured 4 weeks after taking the first medication dose. |
| Weeks 1-4 (the first 4-weeks after first medication dose) |
| 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 | Baseline - week 4 |
| Change in Pre-quit Cigarette Consumption | Participants reported average number of cigarettes smoked per day every week throughout the four week pre-quit period. | Baseline - week 4 |
| 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). | Week 4 - 8 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 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. | Participants that provided data at all time points | Posted | May 2011 | Mean | Standard Deviation | ppm | Baseline - week 8 |
|
|
|
|
| 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. | All participants that provided data at all time points | Posted | May 2011 | Mean | Standard Deviation | ng/ml | Weeks 1-4 (the first 4-weeks after first medication dose) |
|
|
|
|
| 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 | Participants who provided ratings of cigarette satisfaction at each visit | Posted | Mean | Standard Deviation | units on a scale | Baseline - week 4 |
|
|
|
|
| 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. | All participants that provided data at each session | Posted | Mean | Standard Deviation | Cigarettes consumed per day | Baseline - week 4 |
|
|
|
|
| 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). | Participants who were abstinent at 1 week and provided data on withdrawal symptoms | Posted | Mean | Standard Deviation | Scores on a scale | Week 4 - 8 |
|
|
|
|
| 1 |
| 53 |
| 34 |
| 53 |
| EG001 | Placebo | Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting | 1 | 48 | 22 | 48 |
| Musculoskeletal chest pain | Cardiac disorders | Non-systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Sleep disturbance | Psychiatric disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Drowsiness | General disorders | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Sweating | General disorders | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fatigue | Nervous system disorders | Non-systematic Assessment |
|
| Light headedness | Nervous system disorders | Non-systematic Assessment |
|
| Muscularskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Flu like symptoms | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | Non-systematic Assessment |
|
| Poor concentration | General disorders | Non-systematic Assessment |
|
| Skin irritation/rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Bleeding gums | General disorders | Non-systematic Assessment |
|
| Chest pain - not specified | General disorders | Non-systematic Assessment |
|
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| D001519 | Behavior |
| D011810 | Quinoxalines |