Trial Outcomes & Findings for A Pilot Study Evaluating Nicotine Lozenges and Self Help (NCT NCT00888459)
NCT ID: NCT00888459
Last Updated: 2023-10-23
Results Overview
self-reported 7-day point prevalence tobacco abstinence at week 12 (end of treatment)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-10-23
Participant Flow
The first person was pre-screened on 05/20/08 and the last person was randomized on 09/29/08.
Participant milestones
| Measure |
Active
4 mg nicotine lozenges
|
Placebo
placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Study Evaluating Nicotine Lozenges and Self Help
Baseline characteristics by cohort
| Measure |
Active
n=30 Participants
4 mg nicotine lozenges
|
Placebo
n=30 Participants
placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.6 years
STANDARD_DEVIATION 16.0 • n=5 Participants
|
42.4 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
43.0 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Smokeless tobacco
|
3.9 cans/week
STANDARD_DEVIATION 3.1 • n=5 Participants
|
3.7 cans/week
STANDARD_DEVIATION 2.1 • n=7 Participants
|
3.8 cans/week
STANDARD_DEVIATION 2.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: intention to treat
self-reported 7-day point prevalence tobacco abstinence at week 12 (end of treatment)
Outcome measures
| Measure |
Active
n=30 Participants
4 mg nicotine lozenges
|
Placebo
n=30 Participants
placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)
|
|---|---|---|
|
Number of Participants With Tobacco Abstinence
|
14 participants
|
11 participants
|
Adverse Events
Active
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active
n=30 participants at risk
4 mg nicotine lozenges
|
Placebo
n=30 participants at risk
placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)
|
|---|---|---|
|
Gastrointestinal disorders
Heartburn
|
10.0%
3/30 • Number of events 3 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Psychiatric disorders
Sleep disturbance
|
10.0%
3/30 • Number of events 3 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place