Trial Outcomes & Findings for Pilot Study: Preoperative Nicotine Lozenges (NCT NCT00586482)
NCT ID: NCT00586482
Last Updated: 2014-12-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
46 participants
Primary outcome timeframe
Morning of surgery, pre-operatively
Results posted on
2014-12-22
Participant Flow
Subjects were recruited from patients evaluated at the Mayo Clinic Pre-Operative Evaluation Center located in Rochester, Minnesota, in preparation for elective surgery.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
24
|
|
Overall Study
COMPLETED
|
22
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study: Preoperative Nicotine Lozenges
Baseline characteristics by cohort
| Measure |
Nicotine Lozenges
n=22 Participants
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
n=24 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.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
49.8 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
52.7 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
24 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
In-patient surgery
In-Patient Elective Surgery
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
In-patient surgery
Out-Patient Elective Surgery
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Number of cigarettes per day
|
16.8 Cigarettes per day
STANDARD_DEVIATION 6.7 • n=5 Participants
|
17.9 Cigarettes per day
STANDARD_DEVIATION 7.2 • n=7 Participants
|
17.2 Cigarettes per day
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence
|
6.7 Units on a scale
STANDARD_DEVIATION 1.2 • n=5 Participants
|
6.1 Units on a scale
STANDARD_DEVIATION 1.4 • n=7 Participants
|
6.4 Units on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Minnesota Nicotine Withdrawal Score
|
1.5 units on a scale
STANDARD_DEVIATION 0.9 • n=5 Participants
|
1.5 units on a scale
STANDARD_DEVIATION 1.0 • n=7 Participants
|
1.5 units on a scale
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
Pre-operative Abstinence Intention
Intended to abstain prior to surgery
|
18 participants
n=5 Participants
|
19 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Pre-operative Abstinence Intention
Did not intend to abstain prior to surgery
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Morning of surgery, pre-operativelyOutcome measures
| Measure |
Nicotine Lozenges
n=22 Participants
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
n=24 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.
|
|---|---|---|
|
Exhaled Carbon Monoxide Concentration
|
8.3 Parts per million
Standard Deviation 7.5
|
12.7 Parts per million
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: Morning of surgery, pre-operativelyMean number who reported abstinence from smoking from the the time of baseline assessment until the morning of surgery.
Outcome measures
| Measure |
Nicotine Lozenges
n=22 Participants
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
n=24 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.
|
|---|---|---|
|
Self-reported Abstinence
|
16 participants
|
13 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Morning of surgery, pre-operativelyOutcome measures
| Measure |
Nicotine Lozenges
n=22 Participants
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
n=24 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.
|
|---|---|---|
|
Self-reported Time to Last Cigarette
|
21.8 Hours
Standard Deviation 19.5
|
16.7 Hours
Standard Deviation 11.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Morning of surgery, pre-operativelyThis 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.
Outcome measures
| Measure |
Nicotine Lozenges
n=22 Participants
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
n=24 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.
|
|---|---|---|
|
Minnesota Nicotine Withdrawal Score
|
1.3 units on a scale
Standard Deviation 1.0
|
1.4 units on a scale
Standard Deviation 0.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-operative day 8Outcome measures
| Measure |
Nicotine Lozenges
n=22 Participants
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
n=24 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.
|
|---|---|---|
|
Self-reported Abstinence From Smoking
|
11 participants
|
11 participants
|
Adverse Events
Nicotine Lozenge
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Lozenge
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place