Trial Outcomes & Findings for Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction (NCT NCT01018394)

NCT ID: NCT01018394

Last Updated: 2013-09-13

Results Overview

Number of participants who were biochemically confirmed abstinent from tobacco at week 12 using urinary anabasine less than 2 ng per ml.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 81 participants
• Primary outcome timeframe: week 12
• Results posted on: 2013-09-13

Participant Flow

Recruitment began on February 2010 and completed on September 2011. Interested subjects who passed a phone pre-screen were seen at a medical clinic (Mayo Clinic in Rochester, Minnesota and Oregon Research Institute in Eugene, Oregon) for consenting and additional study procedures to determine eligibility.

Participant milestones

Measure	Nicotine Lozenges Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day. nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day.	Tobacco Free Snuff Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed. tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks
Overall Study STARTED	40	41
Overall Study COMPLETED	31	33
Overall Study NOT COMPLETED	9	8

Reasons for withdrawal

Measure	Nicotine Lozenges Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day. nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day.	Tobacco Free Snuff Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed. tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks
Overall Study Withdrawal by Subject	5	5
Overall Study Lost to Follow-up	4	3

Baseline Characteristics

Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction

Baseline characteristics by cohort

Measure	Nicotine Lozenges n=40 Participants Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day. nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day.	Tobacco Free Snuff n=41 Participants Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed. tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks	Total n=81 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants	37 Participants n=7 Participants	73 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age Continuous	37.8 years STANDARD_DEVIATION 15.9 • n=5 Participants	37.5 years STANDARD_DEVIATION 12.5 • n=7 Participants	37.6 years STANDARD_DEVIATION 14.3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	38 Participants n=7 Participants	78 Participants n=5 Participants
Baseline tobacco used per week	3.2 cans of smokeless tobacco STANDARD_DEVIATION 2.1 • n=5 Participants	4.0 cans of smokeless tobacco STANDARD_DEVIATION 2.7 • n=7 Participants	3.6 cans of smokeless tobacco STANDARD_DEVIATION 2.4 • n=5 Participants

PRIMARY outcome

Timeframe: week 12

Number of participants who were biochemically confirmed abstinent from tobacco at week 12 using urinary anabasine less than 2 ng per ml.

Outcome measures

Measure	Nicotine Lozenges n=40 Participants Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day. nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day.	Tobacco Free Snuff n=41 Participants Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed. tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks
Tobacco Abstinence at 12 Weeks	8 participants	5 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, week 4

Percentage of participants who reduced smokeless tobacco use (cans per week) by 50% or more from baseline

Outcome measures

Measure	Nicotine Lozenges n=40 Participants Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day. nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day.	Tobacco Free Snuff n=41 Participants Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed. tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks
Smokeless Tobacco Reduction Greater or Equal to 50%	25 percentage of participants	19 percentage of participants

Adverse Events

Nicotine Lozenges

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Tobacco Free Snuff

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Nicotine Lozenges n=40 participants at risk Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day. nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day.	Tobacco Free Snuff n=41 participants at risk Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed. tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks
General disorders sore throat	2.5% 1/40 • 12 weeks Adverse Events were collected during the medication phase (baseline to week 12).	2.4% 1/41 • 12 weeks Adverse Events were collected during the medication phase (baseline to week 12).
General disorders dizziness	2.5% 1/40 • 12 weeks Adverse Events were collected during the medication phase (baseline to week 12).	0.00% 0/41 • 12 weeks Adverse Events were collected during the medication phase (baseline to week 12).
General disorders insomnia	2.5% 1/40 • 12 weeks Adverse Events were collected during the medication phase (baseline to week 12).	0.00% 0/41 • 12 weeks Adverse Events were collected during the medication phase (baseline to week 12).

Additional Information

Dr. Jon Ebbert

Mayo Clinic

Phone: 507-266-1944

Email: nicotineresearch@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place