Trial Outcomes & Findings for Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine (NCT NCT00710034)

NCT ID: NCT00710034

Last Updated: 2017-12-06

Results Overview

Number of subjects using only the assigned study product at week 6

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 391 participants
• Primary outcome timeframe: 6 week post smoking substitution
• Results posted on: 2017-12-06

Participant Flow

Cigarette smokers interested in completely switching to snus or nicotine gum were recruited from Minneapolis/St Paul, Minnesota, and Eugene, Oregon.

Participant milestones

Measure	Nicotine Gum Nicotine replacement therapy Nicotine Gum: 4 mg Nicotine gum	Snus Oral tobacco Oral tobacco: Snus
Completed 6 Weeks of Treatment STARTED	195	196
Completed 6 Weeks of Treatment COMPLETED	154	149
Completed 6 Weeks of Treatment NOT COMPLETED	41	47
Completed 12 Weeks of Treatment STARTED	154	149
Completed 12 Weeks of Treatment COMPLETED	141	138
Completed 12 Weeks of Treatment NOT COMPLETED	13	11

Reasons for withdrawal

Measure	Nicotine Gum Nicotine replacement therapy Nicotine Gum: 4 mg Nicotine gum	Snus Oral tobacco Oral tobacco: Snus
Completed 6 Weeks of Treatment Adverse Event	5	12
Completed 6 Weeks of Treatment Lack of Efficacy	12	8
Completed 6 Weeks of Treatment Lost to Follow-up	15	17
Completed 6 Weeks of Treatment Product dissatisfaction	2	6
Completed 6 Weeks of Treatment Withdrawal by Subject	6	4
Completed 6 Weeks of Treatment Physician Decision	1	0
Completed 12 Weeks of Treatment Adverse Event	0	1
Completed 12 Weeks of Treatment Lack of Efficacy	0	2
Completed 12 Weeks of Treatment Lost to Follow-up	5	5
Completed 12 Weeks of Treatment Product Dissatisfaction	0	1
Completed 12 Weeks of Treatment Withdrawal by Subject	8	2

Baseline Characteristics

Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine

Baseline characteristics by cohort

Measure	Nicotine Gum n=195 Participants Nicotine replacement therapy Nicotine Gum: 4 mg Nicotine gum	Snus n=196 Participants Oral tobacco Oral tobacco: Snus	Total n=391 Participants Total of all reporting groups
Age, Categorical Between 18 and 65 years	195 Participants n=113 Participants	196 Participants n=163 Participants	391 Participants n=160 Participants
Age, Categorical >=65 years	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Age, Continuous	43.9 years STANDARD_DEVIATION 12.5 • n=113 Participants	43.2 years STANDARD_DEVIATION 12.5 • n=163 Participants	43.9 years STANDARD_DEVIATION 12.5 • n=160 Participants
Sex: Female, Male Female	95 Participants n=113 Participants	89 Participants n=163 Participants	184 Participants n=160 Participants
Age, Categorical <=18 years	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Sex: Female, Male Male	100 Participants n=113 Participants	107 Participants n=163 Participants	207 Participants n=160 Participants
Region of Enrollment United States	195 participants n=113 Participants	196 participants n=163 Participants	391 participants n=160 Participants

PRIMARY outcome

Timeframe: 6 week post smoking substitution

Number of subjects using only the assigned study product at week 6

Outcome measures

Measure	Nicotine Gum n=153 Participants Nicotine replacement therapy Nicotine Gum: 4 mg Nicotine gum	Snus n=149 Participants Oral tobacco Oral tobacco: Snus
Product Effect on Complete Substitution for Smoking	56 participants	56 participants

PRIMARY outcome

Timeframe: 6 weeks post cigarette substitution

Cigarettes per day at mid intervention

Outcome measures

Measure	Nicotine Gum n=149 Participants Nicotine replacement therapy Nicotine Gum: 4 mg Nicotine gum	Snus n=154 Participants Oral tobacco Oral tobacco: Snus
Number of Cigarettes Smoked	18.6 cigarettes per day Standard Deviation 33.8	18.8 cigarettes per day Standard Deviation 28.5

PRIMARY outcome

Timeframe: 6 weeks post smoking substitution

Pieces of product per week at mid intervention

Outcome measures

Measure	Nicotine Gum n=149 Participants Nicotine replacement therapy Nicotine Gum: 4 mg Nicotine gum	Snus n=154 Participants Oral tobacco Oral tobacco: Snus
Number of Products Used	37.6 Pieces per week Standard Deviation 26.3	39.1 Pieces per week Standard Deviation 24.0

SECONDARY outcome

Timeframe: Week 1-12 post switching

Population: Using assigned product only. The numbers of subjects that were only using the assigned product were 40 and 37 for nicotine gum and oral tobacco respectively at week 12. Analysis was conducted from weeks 1-12 post-switching.

Total withdrawal score on the Minnesota Nicotine Withdrawal Scale for subjects using only their assigned study product. This scale measures withdrawal symptoms from cigarettes. There are 8 items on the scale with scores that range from 0 to 4. Total score is calculated by summing the scores (excluding the craving item). Minimum score is 0 and maximum is 28. The higher the score the more severe the withdrawal.

Outcome measures

Measure	Nicotine Gum n=40 Participants Nicotine replacement therapy Nicotine Gum: 4 mg Nicotine gum	Snus n=37 Participants Oral tobacco Oral tobacco: Snus
Products Effect on Withdrawal Symptoms. Baseline Scores	4.17 units on a scale Standard Deviation 5.01	5.01 units on a scale Standard Deviation 5.14
Products Effect on Withdrawal Symptoms. Week 12 Scores	5.57 units on a scale Standard Deviation 6.05	5.73 units on a scale Standard Deviation 6.24

SECONDARY outcome

Timeframe: Baseline and Week 4 post smoking substitution

Total NNAL (e.g., 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides) among those subjects who reported use of assigned product only (baseline and week 4 samples).

Outcome measures

Measure	Nicotine Gum n=58 Participants Nicotine replacement therapy Nicotine Gum: 4 mg Nicotine gum	Snus n=52 Participants Oral tobacco Oral tobacco: Snus
Product Effect on Biomarkers of Exposure and Toxicity Baseline	1.39 pmol//mg creatinine Standard Deviation 1.04	1.28 pmol//mg creatinine Standard Deviation 0.94
Product Effect on Biomarkers of Exposure and Toxicity Week 4	0.30 pmol//mg creatinine Standard Deviation 0.39	1.34 pmol//mg creatinine Standard Deviation 1.55

Adverse Events

Nicotine Gum

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Snus

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Nicotine Gum n=195 participants at risk Nicotine replacement therapy Nicotine Gum: 4 mg Nicotine gum	Snus n=196 participants at risk Oral tobacco Oral tobacco: Snus
Musculoskeletal and connective tissue disorders Death	0.51% 1/195 • Number of events 1 • Subjects were provided study product for 12 weeks.	0.00% 0/196 • Subjects were provided study product for 12 weeks.
Psychiatric disorders Hospitalization	0.00% 0/195 • Subjects were provided study product for 12 weeks.	0.51% 1/196 • Number of events 1 • Subjects were provided study product for 12 weeks.

Other adverse events

Adverse event data not reported

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