Trial Outcomes & Findings for Comparison Across Treatment Conditions to Reduce Smokeless Tobacco Use (NCT NCT00218296)

NCT ID: NCT00218296

Last Updated: 2017-10-16

Results Overview

No tobacco use 7 days prior to Week 12 verified by biomarkers (urine, cotinine and CO)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 332 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2017-10-16

Participant Flow

Subjects were recruited from 3/2007 through 5/2008.

Subjects who called the clinic were randomized to usual care (immediate cessation) or tobacco reduction to quit. Those who did not meet eligibility criteria at their first clinic visit due to unstable health, tobacco use rate, or other exclusionary criteria were dropped from the study.

Participant milestones

Measure	Usual Care Group Usual Care consisted of setting an immediate quit date and receiving 2 weeks of nicotine patch and behavioral counseling during the 6 week intervention period.	Reduction Group Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date. Reduction is facilitated by using nicotine lozenge or ST brand switching resulting in reduced nicotine exposure.
Overall Study STARTED	163	169
Overall Study Attended Visti	97	102
Overall Study COMPLETED	52	48
Overall Study NOT COMPLETED	111	121

Reasons for withdrawal

Measure	Usual Care Group Usual Care consisted of setting an immediate quit date and receiving 2 weeks of nicotine patch and behavioral counseling during the 6 week intervention period.	Reduction Group Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date. Reduction is facilitated by using nicotine lozenge or ST brand switching resulting in reduced nicotine exposure.
Overall Study Lost to Follow-up	9	7
Overall Study Withdrawal by Subject	36	47
Overall Study Randomized but did not enter treatment	66	67

Baseline Characteristics

Comparison Across Treatment Conditions to Reduce Smokeless Tobacco Use

Baseline characteristics by cohort

Measure	Usual Care Group n=97 Participants Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.	Reduction Group n=102 Participants Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.	Total n=199 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	97 Participants n=5 Participants	102 Participants n=7 Participants	199 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	34.4 years STANDARD_DEVIATION 8.4 • n=5 Participants	35.1 years STANDARD_DEVIATION 8.6 • n=7 Participants	34.8 years STANDARD_DEVIATION 8.5 • 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	97 Participants n=5 Participants	102 Participants n=7 Participants	199 Participants n=5 Participants
Region of Enrollment United States	97 participants n=5 Participants	102 participants n=7 Participants	199 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Intent to treat

No tobacco use 7 days prior to Week 12 verified by biomarkers (urine, cotinine and CO)

Outcome measures

Measure	Usual Care Group n=163 Participants Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.	Reduction Group n=169 Participants Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
Percent Abstinent From Tobacco at Week 12 (7 Day Point Prevalence)	31 percentage of randomized	17 percentage of randomized

PRIMARY outcome

Timeframe: 12 weeks

Continuous tobacco cessation from quit date through Week 12 verified by biomarkers (urine, cotinine and CO)

Outcome measures

Measure	Usual Care Group n=163 Participants Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.	Reduction Group n=169 Participants Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
Percent Prolonged Abstinence From Tobacco at Week 12	13 percentage of randomized	4 percentage of randomized

PRIMARY outcome

Timeframe: 26 week

Abstinence from tobacco 7 days prior to Week 26 (Assessed at 26 weeks for Usual Care and 20 weeks for Reduction Group post-quit date)

Outcome measures

Measure	Usual Care Group n=163 Participants Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.	Reduction Group n=169 Participants Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
Percent Abstinent From Tobacco at Week 26 (7 Day Point Prevalence)	20 percentage of randomized	10 percentage of randomized

PRIMARY outcome

Timeframe: 26 weeks

Population: Intent to treat

Continuous Abstinence from quit date through Week 26 (Assessed at Week 26 for Usual Care and Week 20 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).

Outcome measures

Measure	Usual Care Group n=163 Participants Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.	Reduction Group n=169 Participants Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
Percent Prolonged Abstinence From Tobacco at Week 26	11 percentage of randomized	1 percentage of randomized

PRIMARY outcome

Timeframe: 32 Weeks

Abstinence from tobacco 7 days prior to Week 26 (Assessed at Week 32 for Usual Care and Week 26 for Reduction Group. Reduction Group's quit date is 6 weeks later than Usual Care).

Outcome measures

Measure	Usual Care Group n=163 Participants Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.	Reduction Group n=169 Participants Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
Percent Abstinent From Tobacco at Week 32 (7 Day Point Prevalence)	20 percentage of randomized	11 percentage of randomized

PRIMARY outcome

Timeframe: 32 Weeks

Continuous Abstinence from quit date through Week 32 (Assessed at Week 32 for Usual Care and Week 26 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).

Outcome measures

Measure	Usual Care Group n=163 Participants Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.	Reduction Group n=169 Participants Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
Percent Prolonged Abstinence From Tobacco at Week 32	11 percentage of randomized	1 percentage of randomized

Adverse Events

Usual Care Group

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

Reduction Group

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Usual Care Group n=97 participants at risk Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.	Reduction Group n=102 participants at risk Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
General disorders Sleep Disturbance	19.6% 19/97 • Number of events 19 • 6 weeks	2.9% 3/102 • Number of events 3 • 6 weeks
General disorders Dry Mouth	4.1% 4/97 • Number of events 4 • 6 weeks	8.8% 9/102 • Number of events 12 • 6 weeks
General disorders Headache	8.2% 8/97 • Number of events 8 • 6 weeks	12.7% 13/102 • Number of events 18 • 6 weeks
Musculoskeletal and connective tissue disorders Muscle Aches	6.2% 6/97 • Number of events 7 • 6 weeks	0.00% 0/102 • 6 weeks
General disorders Redness at Patch Site	8.2% 8/97 • Number of events 8 • 6 weeks	0.00% 0/102 • 6 weeks
Skin and subcutaneous tissue disorders Pruritus	21.6% 21/97 • Number of events 22 • 6 weeks	0.00% 0/102 • 6 weeks

Additional Information

Dorothy Hatsukami, Ph.D.

University of Minnesota

Phone: 612-626-2121

Email: hatsu001@umn.edu

Results disclosure agreements

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