A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco

• Sponsor: Medical University of South Carolina (Other)
• Overall Status: Completed
• CT.gov ID: NCT01509586
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 1,236
• Location: 1
• Arms: 2
• Duration (Months): 52
• Patients Per Site Per Month: 23.8

Study Details

Study Description

Brief Summary

This nationwide telephone and mail- based research study will recruit 1,400 cigarette smokers who are not motivated to quit to test the effects of a marketed oral, non-combustible smokeless tobacco product on cigarette smoking behaviors. It will also track the participants' usage patterns of the smokeless tobacco product.

Half of the participants will receive a new, potentially safer tobacco product during the first six weeks of the study, and half will not. During this six-week period, each participant will complete three brief phone interviews. After this first six week period, participants will complete 6 other brief follow-up interviews, where they will answer questionnaires about their smoking habits.

Condition or Disease	Intervention/Treatment	Phase
Smoking; Smoking Cessation	Drug: Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1236 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PREP (Potentially Reduced Exposure Product) Group	Drug: Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product; The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
No Intervention: cigarette group

Outcome Measures

Primary Outcome Measures

1. Quit Attempts and Abstinence [From study enrollment through end of one-year follow up]

   % of study participants making a quit attempt or staying abstinent from smoking during the study Notes: Floating abstinence: Any 7-day period of non-smoking, ever within study. PPA: point-prevalence abstinence

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age >=19

• a daily cigarette smoker of >=10 cigs/day

• English speaking

• live in the contiguous U.S.

• unmotivated to quit smoking in the next 30 days

Exclusion Criteria:

• no use of smokeless tobacco in past six months

• not breastfeeding, pregnant, or planning a pregnancy

• devoid of any recent (past 6 months) cardiovascular trauma

• no quit attempt of >=1 week in past 6 months

• no use of pharmacotherapy to quit smoking in past 3 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

• Medical University of South Carolina
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Matthew J. Carpenter, Ph.D., Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT01509586
• Other Study ID Numbers: Pro00007428; R01CA154992
• First Posted: Jan 13, 2012
• Last Update Posted: Aug 1, 2016
• Last Verified: Jan 1, 2015

• Keywords provided by Medical University of South Carolina: smoking; smoking cessation; Potentially Reduced Exposure Products (PREPs)
• Additional relevant MeSH terms: Lobeline

Study Results

Participant Flow

Arm/Group Title	PREP (Potentially Reduced Exposure Product) Group	Cigarette Group
Arm/Group Description	Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.	This group will smoke their normal cigarettes as much or as little as they want to.
Period Title: Overall Study
STARTED	626	610
Week 3	574	585
Week 6	551	585
Week 10	537	574
Week 14	528	566
Week18	529	555
Week 32 (Month 6)	504	523
Week 46	483	494
Week 58 (Month 12)	492	499
COMPLETED	626	610
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	PREP (Potentially Reduced Exposure Product) Group	Cigarette Group	Total
Arm/Group Description	Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.	This group will smoke their normal cigarettes as much or as little as they want to.	Total of all reporting groups
Overall Participants	626	610	1236
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.7 (12.5)	48.7 (12.6)	48.7 (12.6)
Sex: Female, Male (Count of Participants)
Female	438 70%	397 65.1%	835 67.6%
Male	188 30%	213 34.9%	401 32.4%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	557 89%	531 87%	1088 88%
African-American	56 8.9%	61 10%	117 9.5%
Other	13 2.1%	18 3%	31 2.5%
Intend to quit smoking, next month (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	1.4 (2.3)	1.3 (2.4)	1.4 (2.4)
Confidence to quit smoking (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.6 (3.1)	2.7 (3.0)	2.7 (3.1)
Cigarettes per day (average cigarettes per day at baseline) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [average cigarettes per day at baseline]	20.1 (8.7)	19.9 (8.4)	20.0 (8.6)

Outcome Measures

1. Primary Outcome

Title	Quit Attempts and Abstinence
Description	% of study participants making a quit attempt or staying abstinent from smoking during the study Notes: Floating abstinence: Any 7-day period of non-smoking, ever within study. PPA: point-prevalence abstinence
Time Frame	From study enrollment through end of one-year follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PREP (Potentially Reduced Exposure Product) Group	Cigarette Group
Arm/Group Description	Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.	This group will smoke their normal cigarettes as much or as little as they want to.
Measure Participants	626	610
Any quit attempt, ever within study	25.7 4.1%	30.8 5%
Any 24 h quit attempt, ever within study	19.8 3.2%	25.6 4.2%
Floating abstinence	14.9 2.4%	16.2 2.7%
Week 32 PPA	6.2 1%	5.6 0.9%
Week 58 PPA	5.1 0.8%	5.6 0.9%

Adverse Events

Time Frame	Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
Arm/Group Title	PREP (Potentially Reduced Exposure Product) Group		Cigarette Group
Arm/Group Description	Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.		This group will smoke their normal cigarettes as much or as little as they want to.
All Cause Mortality
	PREP (Potentially Reduced Exposure Product) Group		Cigarette Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	PREP (Potentially Reduced Exposure Product) Group		Cigarette Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/626 (0.5%)		3/610 (0.5%)
General disorders
Death	3/626 (0.5%)		3/610 (0.5%)
Other (Not Including Serious) Adverse Events
	PREP (Potentially Reduced Exposure Product) Group		Cigarette Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	458/626 (73.2%)		414/610 (67.9%)
Gastrointestinal disorders
nausea	93/626 (14.9%)		82/610 (13.4%)
heartburn	68/626 (10.9%)		51/610 (8.4%)
mouth soreness	46/626 (7.3%)		43/610 (7%)
hiccups	44/626 (7%)		21/610 (3.4%)
burning in throat/mouth	59/626 (9.4%)		21/610 (3.4%)
General disorders
headache	79/626 (12.6%)		93/610 (15.2%)
dizziness or lightheadnedness	54/626 (8.6%)		61/610 (10%)
dry mouth	53/626 (8.5%)		57/610 (9.3%)
sore jaw	14/626 (2.2%)		18/610 (3%)
excessive salivation	29/626 (4.6%)		15/610 (2.5%)
insomnia	66/626 (10.5%)		70/610 (11.5%)
other	338/626 (54%)		332/610 (54.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.