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The goal of this pilot study is to determine the feasibility and potential effect size of nicotine lozenges as an adjunct to maintain brief preoperative abstinence, defined as not smoking the day of surgery.
Nicotine replacement therapy (NRT) helps patients maintain prolonged abstinence; whether it might also be efficacious in helping smokers maintain preoperative "fasting" from smoking is not known. A goal of this study is to determine how to best decrease smokers' exposure to cigarette smoke immediately before surgery. The specific aim of this study is to test the hypothesis that NRT in the form of nicotine lozenges will decrease the exposure to cigarette smoke prior to surgery. This is a randomized, double blinded, placebo controlled clinical trial examining the efficacy of the nicotine lozenge in increasing preoperative abstinence from cigarettes in patients scheduled for elective surgery. Current smokers scheduled for any of a wide variety of elective surgical procedures will be recruited in the Mayo Clinic Rochester Preoperative Evaluation Center. and will receive a brief practice-based intervention encouraging preoperative abstinence for at least 12 hours before admission to the surgical facility. They will be randomized to receive either active or placebo lozenge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine lozenge | Active Comparator | Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used. Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times. |
|
| Placebo lozenge | Placebo Comparator | Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day. Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Lozenge | Drug | Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day and a 2 minute behavioral intervention. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used. |
| Measure | Description | Time Frame |
|---|---|---|
| Exhaled Carbon Monoxide Concentration | Morning of surgery, pre-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Abstinence | Mean number who reported abstinence from smoking from the the time of baseline assessment until the morning of surgery. | Morning of surgery, pre-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Time to Last Cigarette | Morning of surgery, pre-operatively | |
| Minnesota Nicotine Withdrawal Score | This item was measured using the Minnesota Nicotine Withdrawal Questionnaire, self-reported for the prior 24 hour period. This questionnaire consists of 15 items, each rated from 0 to 4, with a possible score of 0 to 60. A lower score indicates lesser withdrawal symptoms, and a higher score indicates greater withdrawal symptoms. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David O Warner, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Warner DO, Kadimpati S. Nicotine lozenges to promote frief preopve abstinence from smoking: pilot study. Clin Health Promot 2(3):85-88, 2012. |
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Subjects were recruited from patients evaluated at the Mayo Clinic Pre-Operative Evaluation Center located in Rochester, Minnesota, in preparation for elective surgery.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nicotine Lozenges | Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used. Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times. |
| FG001 | Placebo Lozenge | Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day. Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicotine Lozenges | Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used. Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Exhaled Carbon Monoxide Concentration | Posted | Mean | Standard Deviation | Parts per million | Morning of surgery, pre-operatively |
|
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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 | Nicotine Lozenge | Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used. Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David O. Warner, MD | Mayo Clinic | 507-255-4288 | warner.david@mayo.edu |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
|
| Placebo Lozenge | Drug | Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day and a 2 minute behavioral intervention. |
|
| Abstinence Advisement | Behavioral | A brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times. |
|
| Morning of surgery, pre-operatively |
| Self-reported Abstinence From Smoking | Post-operative day 8 |
| BG001 | Placebo Lozenge | Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day. Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| In-patient surgery | Number | participants |
|
| Number of cigarettes per day | Mean | Standard Deviation | Cigarettes per day |
|
| Fagerstrom Test for Nicotine Dependence | This instrument consists of 6 questions related to cigarette smoking and nicotine dependency. Scores can range from 0 to 10. A score of 5 or less suggests low to moderate nicotine dependency. A score of 6 or higher indicates high nicotine dependency. | Mean | Standard Deviation | Units on a scale |
|
| Minnesota Nicotine Withdrawal Score | This item was measured using the Minnesota Nicotine Withdrawal Questionnaire, self-reported for the prior 24 hour period. This questionnaire consists of 15 items, each rated from 0 to 4, with a possible score of 0 to 60. A lower score indicates lesser withdrawal symptoms, and a higher score indicates greater withdrawal symptoms. | Mean | Standard Deviation | units on a scale |
|
| Pre-operative Abstinence Intention | Number | participants |
|
Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.
Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times.
|
|
|
| Secondary | Self-reported Abstinence | Mean number who reported abstinence from smoking from the the time of baseline assessment until the morning of surgery. | Posted | Number | participants | Morning of surgery, pre-operatively |
|
|
|
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| Other Pre-specified | Self-reported Time to Last Cigarette | Posted | Mean | Standard Deviation | Hours | Morning of surgery, pre-operatively |
|
|
|
|
| Other Pre-specified | Minnesota Nicotine Withdrawal Score | This item was measured using the Minnesota Nicotine Withdrawal Questionnaire, self-reported for the prior 24 hour period. This questionnaire consists of 15 items, each rated from 0 to 4, with a possible score of 0 to 60. A lower score indicates lesser withdrawal symptoms, and a higher score indicates greater withdrawal symptoms. | Posted | Mean | Standard Deviation | units on a scale | Morning of surgery, pre-operatively |
|
|
|
|
| Other Pre-specified | Self-reported Abstinence From Smoking | Posted | Number | participants | Post-operative day 8 |
|
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Placebo Lozenge | Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day. Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times. | 0 | 24 | 0 | 24 |
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