Trial Outcomes & Findings for Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction (NCT NCT00392379)

NCT ID: NCT00392379

Last Updated: 2013-04-24

Results Overview

Participants had to have self-reported not having used any tobacco from two weeks past the target quit date to the 3-months post baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 270 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2013-04-24

Participant Flow

The study was conducted at the Mayo Clinic in Rochester, MN, and the Oregon Research Institute (ORI) in Eugene, OR. Enrollment took place between January, 2007 and April, 2008. Smokeless tobacco (ST) users were recruited through press releases and advertising from the surrounding communities.

Participant milestones

Measure	Nicotine Lozenge Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.	Placebo Nicotine Lozenge Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
Overall Study STARTED	136	134
Overall Study COMPLETED	114	96
Overall Study NOT COMPLETED	22	38

Reasons for withdrawal

Measure	Nicotine Lozenge Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.	Placebo Nicotine Lozenge Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
Overall Study Withdrawal by Subject	17	28
Overall Study Lost to Follow-up	4	9
Overall Study Adverse Event	1	1

Baseline Characteristics

Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction

Baseline characteristics by cohort

Measure	Nicotine Lozenge n=136 Participants Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.	Placebo Nicotine Lozenge n=134 Participants Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.	Total n=270 Participants Total of all reporting groups
Age Continuous	36.6 years STANDARD_DEVIATION 10.7 • n=5 Participants	36.5 years STANDARD_DEVIATION 11.0 • n=7 Participants	36.6 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	136 Participants n=5 Participants	128 Participants n=7 Participants	264 Participants n=5 Participants
Region of Enrollment United States	136 participants n=5 Participants	134 participants n=7 Participants	270 participants n=5 Participants
ST Use	4.3 Cans/week STANDARD_DEVIATION 2.6 • n=5 Participants	4.2 Cans/week STANDARD_DEVIATION 2.6 • n=7 Participants	4.2 Cans/week STANDARD_DEVIATION 2.6 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: ITT

Participants had to have self-reported not having used any tobacco from two weeks past the target quit date to the 3-months post baseline.

Outcome measures

Measure	Nicotine Lozenge n=136 Participants Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.	Placebo Nicotine Lozenge n=134 Participants Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
Prolonged Smokeless Tobacco Abstinence at 3 Months	65 Participants	41 Participants

SECONDARY outcome

Timeframe: 3 months

Participants had to have self-reported not having used any tobacco for the 7 days prior to the 3 month visit.

Outcome measures

Measure	Nicotine Lozenge n=136 Participants Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.	Placebo Nicotine Lozenge n=134 Participants Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
Self-reported Point Prevalence All Tobacco Abstinence at 3 Months	60 Participants	39 Participants

SECONDARY outcome

Timeframe: 6 months

Participants had to have self-reported not having used any tobacco from 2 weeks after the target quit date to 6 months after baseline (22 weeks).

Outcome measures

Measure	Nicotine Lozenge n=136 Participants Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.	Placebo Nicotine Lozenge n=134 Participants Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
Prolonged Smokeless Tobacco Abstinence at 6 Months	41 Participants	31 Participants

Adverse Events

Nicotine Lozenge

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Placebo Nicotine Lozenge

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Nicotine Lozenge n=136 participants at risk Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.	Placebo Nicotine Lozenge n=134 participants at risk Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
Gastrointestinal disorders Reflux	11.0% 15/136 • 1 year	0.75% 1/134 • 1 year
Nervous system disorders Sleep disturbance	5.9% 8/136 • 1 year	6.7% 9/134 • 1 year
Nervous system disorders Headache	7.4% 10/136 • 1 year	5.2% 7/134 • 1 year

Additional Information

Jon O. Ebbert, MD

Mayo Clinic

Phone: 507-266-1944

Email: nicotineresearch@mayo.edu

Results disclosure agreements

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