Trial Outcomes & Findings for Health Effects of SLT, Cigarette Smoking, and New Tobacco Products (NCT NCT00469079)

NCT ID: NCT00469079

Last Updated: 2019-11-01

Results Overview

Levels of carcinogen biomarkers (NNAL) reported as difference between baseline and week 4 scores.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

130 participants

Primary outcome timeframe

Baseline, 4 weeks

Results posted on

2019-11-01

Participant Flow

Healthy smokers were recruited from the Twin Cities, MN metro area from November of 2006 through October of 2008.

Participant milestones

Participant milestones
Measure	Assigned to NRT Nicotine gum or nicotine lozenge	Assigned to Taboka Taboka - oral tobacco product	Assigned to Camel Snus Camel Snus - oral tobacco product
Overall Study STARTED	27	52	51
Overall Study COMPLETED	18	30	32
Overall Study NOT COMPLETED	9	22	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Assigned to NRT Nicotine gum or nicotine lozenge	Assigned to Taboka Taboka - oral tobacco product	Assigned to Camel Snus Camel Snus - oral tobacco product
Overall Study Lack of Efficacy	3	8	5
Overall Study Adverse Event	1	3	2
Overall Study Lost to Follow-up	4	8	10
Overall Study Withdrawal by Subject	1	2	2
Overall Study Ineligible	0	1	0

Baseline Characteristics

Health Effects of SLT, Cigarette Smoking, and New Tobacco Products

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Assigned to NRT n=27 Participants Nicotine gum or nicotine lozenge	Assigned to Taboka n=52 Participants Taboka - oral tobacco product	Assigned to Camel Snus n=51 Participants Camel Snus - oral tobacco product	Total n=130 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=99 Participants	52 Participants n=107 Participants	51 Participants n=206 Participants	130 Participants n=7 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Age, Continuous	42.4 years STANDARD_DEVIATION 12.8 • n=99 Participants	42.4 years STANDARD_DEVIATION 11.2 • n=107 Participants	43.6 years STANDARD_DEVIATION 11.5 • n=206 Participants	42.8 years STANDARD_DEVIATION 11.8 • n=7 Participants
Sex: Female, Male Female	12 Participants n=99 Participants	21 Participants n=107 Participants	20 Participants n=206 Participants	53 Participants n=7 Participants
Sex: Female, Male Male	15 Participants n=99 Participants	31 Participants n=107 Participants	31 Participants n=206 Participants	77 Participants n=7 Participants
Region of Enrollment United States	27 participants n=99 Participants	52 participants n=107 Participants	51 participants n=206 Participants	130 participants n=7 Participants
Fagerstrom Test for Nicotine Dependence Score	5.2 Scores on a scale STANDARD_DEVIATION 1.2 • n=99 Participants	3.8 Scores on a scale STANDARD_DEVIATION 1.1 • n=107 Participants	4.4 Scores on a scale STANDARD_DEVIATION 1.6 • n=206 Participants	4.5 Scores on a scale STANDARD_DEVIATION 1.3 • n=7 Participants

PRIMARY outcome

Timeframe: Baseline, 4 weeks

Population: All subjects who continued in the protocol were analyzed. Non-parametric Kruskal-Wallis method of analysis was used.

Levels of carcinogen biomarkers (NNAL) reported as difference between baseline and week 4 scores.

Outcome measures

Outcome measures
Measure	Medicinal Nicotine n=19 Participants 4 mg nicotine gum or nicotine lozenge	Taboka n=30 Participants Taboka, a spitless oral tobacco product that has been discontinued. The product is pasteurized rather than fermented, leading to lower tobacco specific nitrosamine levels than conventional smokeless tobacco products.	Snus n=33 Participants Camel Snus, a spitless oral tobacco product currently marketed as a substitute for cigarettes. The product is pasteurized rather than fermented, leading to lower tobacco specific nitrosamine levels than conventional smokeless tobacco products.
Toxicant Exposure by Products Cotinine	835.3 ng/ml Interval 351.5 to 1984.9	782.1 ng/ml Interval 414.5 to 1475.6	726.8 ng/ml Interval 333.7 to 1582.8
Toxicant Exposure by Products Total NNAL	0.157 ng/ml Interval 0.096 to 0.255	0.281 ng/ml Interval 0.182 to 0.435	0.296 ng/ml Interval 0.191 to 0.458
Toxicant Exposure by Products Total NNN	0.010 ng/ml Interval 0.003 to 0.034	0.011 ng/ml Interval 0.004 to 0.027	0.026 ng/ml Interval 0.012 to 0.057

PRIMARY outcome

Timeframe: 4 weeks

Population: All subjects who completed intervention.

Self-reported daily use of the assigned study product. Range of scores is from 0 to about 20. Higher scores do not represent either a better or a worse outcome. Higher number of product used per day may indicate higher abuse liability of the product but may lead to a greater suppression in usual brand cigarette smoking. Lower number of product use per day may indicate lower abuse liability but may lead to lower suppression of usual brand smoking.

Outcome measures

Outcome measures
Measure	Medicinal Nicotine n=18 Participants 4 mg nicotine gum or nicotine lozenge	Taboka n=30 Participants Taboka, a spitless oral tobacco product that has been discontinued. The product is pasteurized rather than fermented, leading to lower tobacco specific nitrosamine levels than conventional smokeless tobacco products.	Snus n=32 Participants Camel Snus, a spitless oral tobacco product currently marketed as a substitute for cigarettes. The product is pasteurized rather than fermented, leading to lower tobacco specific nitrosamine levels than conventional smokeless tobacco products.
Product Use at Week 4 of Intervention	7.27 uses per day Standard Error 0.55	5.27 uses per day Standard Error 0.42	6.76 uses per day Standard Error 0.40

PRIMARY outcome

Timeframe: 12 weeks

Population: Intent to treat model.

This study was not powered to detect differences in smoking cessation rates between groups; however, smoking status was collected at each visit to obtain preliminary data. Point prevalence (no smoking during the previous 7 days) cigarette abstinence rates were calculated at the end of treatment and at each of the 2 follow-up visits (week 1 and 11 post-intervention). Continuous abstinence rates were calculated for the 4 week period between the week 1 and week 4 visits. Abstinence at all visits was assessed by self-report (i.e., no cigarettes smoked) and confirmed by an exhaled CO of less than 8 ppm. At the follow-up visits, abstinence was also confirmed by both exhaled CO concentrations and urinary cotinine concentration (\<35 ng/mL).

Outcome measures

Outcome measures
Measure	Medicinal Nicotine n=27 Participants 4 mg nicotine gum or nicotine lozenge	Taboka n=52 Participants Taboka, a spitless oral tobacco product that has been discontinued. The product is pasteurized rather than fermented, leading to lower tobacco specific nitrosamine levels than conventional smokeless tobacco products.	Snus n=51 Participants Camel Snus, a spitless oral tobacco product currently marketed as a substitute for cigarettes. The product is pasteurized rather than fermented, leading to lower tobacco specific nitrosamine levels than conventional smokeless tobacco products.
Abstinence From Tobacco at End of Treatment, 1 Week and 11 Weeks Post-intervention. End of intervention continuous abstinence	11 participants	17 participants	22 participants
Abstinence From Tobacco at End of Treatment, 1 Week and 11 Weeks Post-intervention. 11 weeks post intervention point prevalence	9 participants	12 participants	16 participants
Abstinence From Tobacco at End of Treatment, 1 Week and 11 Weeks Post-intervention. 1 week post-intervention point prevalence	15 participants	22 participants	24 participants

SECONDARY outcome

Timeframe: Baseline and 1 week

Population: All subjects completing the intervention

Changes in craving and withdrawal symptoms were assessed at the time of discontinuation of usual brand cigarettes (i.e., baseline compared to week 1). Assessments were made using the Minnesota Nicotine Withdrawal Scale, which measures abstinence effects from usual brand cigarettes. Total Score: Range of scores is from 0 to 28. All items with the exclusion of craving are summed. Craving Score: Range of score is from 0 to 4. A higher score would indicate more severe withdrawal.

Outcome measures

Outcome measures
Measure	Medicinal Nicotine n=18 Participants 4 mg nicotine gum or nicotine lozenge	Taboka n=30 Participants Taboka, a spitless oral tobacco product that has been discontinued. The product is pasteurized rather than fermented, leading to lower tobacco specific nitrosamine levels than conventional smokeless tobacco products.	Snus n=32 Participants Camel Snus, a spitless oral tobacco product currently marketed as a substitute for cigarettes. The product is pasteurized rather than fermented, leading to lower tobacco specific nitrosamine levels than conventional smokeless tobacco products.
Product Effect on Craving and Nicotine Withdrawal Symptoms at 1 Week. Craving Scores	2.55 units on a scale Standard Error 0.18	2.76 units on a scale Standard Error 0.14	2.62 units on a scale Standard Error 0.13
Product Effect on Craving and Nicotine Withdrawal Symptoms at 1 Week. Nicotine Withdrawal Scores	8.15 units on a scale Standard Error 1.17	8.89 units on a scale Standard Error 0.86	8.61 units on a scale Standard Error 0.83

Adverse Events

Assigned to NRT

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Assigned to Taboka

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Assigned to Camel Snus

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dorothy Hatsukami, Ph.D.

University of Minnesota

Phone: 612-626-2121

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Assigned to NRT n=27 participants at risk Nicotine gum or nicotine lozenge	Assigned to Taboka n=52 participants at risk Taboka - oral tobacco product	Assigned to Camel Snus n=51 participants at risk Camel Snus - oral tobacco product
General disorders Dry Mouth	14.8% 4/27 • Number of events 6 • Adverse events were collected during 4 weeks on study product.	21.2% 11/52 • Number of events 16 • Adverse events were collected during 4 weeks on study product.	48.1% 13/27 • Number of events 27 • Adverse events were collected during 4 weeks on study product.
General disorders Headaches	22.2% 6/27 • Number of events 10 • Adverse events were collected during 4 weeks on study product.	15.4% 8/52 • Number of events 8 • Adverse events were collected during 4 weeks on study product.	13.7% 7/51 • Number of events 10 • Adverse events were collected during 4 weeks on study product.
Ear and labyrinth disorders Dizziness	3.7% 1/27 • Number of events 1 • Adverse events were collected during 4 weeks on study product.	11.5% 6/52 • Number of events 6 • Adverse events were collected during 4 weeks on study product.	3.9% 2/51 • Number of events 2 • Adverse events were collected during 4 weeks on study product.
General disorders Lightheadedness	7.4% 2/27 • Number of events 2 • Adverse events were collected during 4 weeks on study product.	9.6% 5/52 • Number of events 5 • Adverse events were collected during 4 weeks on study product.	3.9% 2/51 • Number of events 2 • Adverse events were collected during 4 weeks on study product.
Gastrointestinal disorders Nausea	7.4% 2/27 • Number of events 2 • Adverse events were collected during 4 weeks on study product.	19.2% 10/52 • Number of events 14 • Adverse events were collected during 4 weeks on study product.	11.8% 6/51 • Number of events 11 • Adverse events were collected during 4 weeks on study product.
Gastrointestinal disorders Stomach Aches	18.5% 5/27 • Number of events 6 • Adverse events were collected during 4 weeks on study product.	9.6% 5/52 • Number of events 7 • Adverse events were collected during 4 weeks on study product.	21.6% 11/51 • Number of events 14 • Adverse events were collected during 4 weeks on study product.
Gastrointestinal disorders Constipation	7.4% 2/27 • Number of events 2 • Adverse events were collected during 4 weeks on study product.	5.8% 3/52 • Number of events 3 • Adverse events were collected during 4 weeks on study product.	3.9% 2/51 • Number of events 2 • Adverse events were collected during 4 weeks on study product.
Gastrointestinal disorders Diarrhea	11.1% 3/27 • Number of events 3 • Adverse events were collected during 4 weeks on study product.	1.9% 1/52 • Number of events 1 • Adverse events were collected during 4 weeks on study product.	9.8% 5/51 • Number of events 7 • Adverse events were collected during 4 weeks on study product.
General disorders Sore Jaw or Jaw Pain	14.8% 4/27 • Number of events 7 • Adverse events were collected during 4 weeks on study product.	1.9% 1/52 • Number of events 1 • Adverse events were collected during 4 weeks on study product.	5.9% 3/51 • Number of events 4 • Adverse events were collected during 4 weeks on study product.
General disorders Shakiness	3.7% 1/27 • Number of events 1 • Adverse events were collected during 4 weeks on study product.	9.6% 5/52 • Number of events 6 • Adverse events were collected during 4 weeks on study product.	2.0% 1/51 • Number of events 2 • Adverse events were collected during 4 weeks on study product.
General disorders Hiccups	11.1% 3/27 • Number of events 7 • Adverse events were collected during 4 weeks on study product.	5.8% 3/52 • Number of events 4 • Adverse events were collected during 4 weeks on study product.	39.2% 20/51 • Number of events 35 • Adverse events were collected during 4 weeks on study product.
General disorders Sore Throat	22.2% 6/27 • Number of events 8 • Adverse events were collected during 4 weeks on study product.	5.8% 3/52 • Number of events 3 • Adverse events were collected during 4 weeks on study product.	9.8% 5/51 • Number of events 10 • Adverse events were collected during 4 weeks on study product.
Skin and subcutaneous tissue disorders Mouth Sores	14.8% 4/27 • Number of events 4 • Adverse events were collected during 4 weeks on study product.	11.5% 6/52 • Number of events 7 • Adverse events were collected during 4 weeks on study product.	31.4% 16/51 • Number of events 27 • Adverse events were collected during 4 weeks on study product.
General disorders Sleep Disturbance	29.6% 8/27 • Number of events 9 • Adverse events were collected during 4 weeks on study product.	19.2% 10/52 • Number of events 12 • Adverse events were collected during 4 weeks on study product.	21.6% 11/51 • Number of events 14 • Adverse events were collected during 4 weeks on study product.
General disorders Excessive Salivation	14.8% 4/27 • Number of events 11 • Adverse events were collected during 4 weeks on study product.	13.5% 7/52 • Number of events 9 • Adverse events were collected during 4 weeks on study product.	29.4% 15/51 • Number of events 30 • Adverse events were collected during 4 weeks on study product.