Palatability of Experimental Cigarettes - Study 2

• Sponsor: University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT01568905
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 3
• Duration (Months): 12.9
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

Smoking remains a leading cause of preventable disease and premature death worldwide. Approximately 1 out of every 5 deaths is associated with cigarette smoking, and roughly half of all daily smokers will die prematurely from tobacco-related illness. Reducing the nicotine in cigarettes to the point that they are rendered non-addictive can potentially be an effective public policy measure that can significantly reduce tobacco-related mortality and morbidity by decreasing the initiation of smoking and promoting cessation. The Family Smoking Prevention and Tobacco Control Act (FSPTCA) enables the FDA to establish tobacco product standards including placing limits on the allowable nicotine content of cigarettes. Currently, no reduced nicotine cigarettes are available that will allow studying the feasibility of this policy measure. The National Institute on Drug Abuse has contracted with Research Triangle Institute to assist in the development of cigarettes with varying nicotine content that can be made available to researchers. They have established a contract that will result in the manufacture of 9 million cigarettes to be distributed to the research community. Prior to full production, the palatability and nicotine intake of these cigarettes in smokers must be determined.

Condition or Disease	Intervention/Treatment	Phase
Smoking	Other: Low level nicotine cigarette; Other: Intermediate nicotine level cigarette; Other: High level nicotine cigarette	N/A

Detailed Description

Phase 3: This descriptive study will use a between subjects, double blind design. This study will test 3 nicotine levels of nicotine, tar and ventilation. Subjects and research assistants will be blind to the cigarette type.

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Palatability of Experimental Cigarettes
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Low Level Nicotine Cigarette (0.4 mg/g)	Other: Low level nicotine cigarette; smoke the study cigarette exclusively for one week
Experimental: Arm 2 Intermediate Nicotine Level Cigarette (5.7-5.8 mg/g)	Other: Intermediate nicotine level cigarette; smoke the study cigarette exclusively for one week
Experimental: Arm 3 High Level Nicotine Cigarette (11.4-12.8 mg/g)	Other: High level nicotine cigarette; smoke the study cigarette exclusively for one week

Outcome Measures

Primary Outcome Measures

1. Change in UrineTotal Nicotine Equivalent (TNE) Between Baseline and Week 1 [Second Visit (Week 1) minus Baseline (Day 1)]

   Two urine TNE levels are taken, one at baseline and one at week 1, to assess TNE levels for nicotine exposure. TNE is the sum of nicotine, cotinine, trans 3'-hydroxycotinine and their respective glucuronide conjugates. Values reported in nmols/ml.

Secondary Outcome Measures

1. Responses on Modified Cigarette Evaluation Scale [Baseline usual brand cigarettes (Day 1) compared to when using study cigarettes (Week 1)]

   Modified Cigarette Evaluation Scale [CES] is a 100 mm visual analog scale (0=not at all or very little nicotine; 100=extremely or high in nicotine) of 20 questions assessing different dimensions of responses to usual brand cigarettes (e.g., psychological reward, satisfaction and aversiveness) and includes additional 5 point likert-type questions (definitely agree to definitely disagree) on perceptions of satisfaction and willingness to use the product. Results satisfaction subscale.

2. Change From Baseline of Perceived Health Risk Scale Response to Test Cigarettes [Baseline (Day 1) Compared to Second Visit (Week 1)]

   Questionnaire: Perceived Health Risk Scale asks subjects to rate their perception of health risks for lung cancer for the study product to which they have been randomly assigned. This is a 100 mm visual analog scale; 0=very low risk of disease, 100=very high risk of disease.

3. Comparison of Number of Cigarettes Smoked [1 week]

   Subjects were given a daily diary to collect the number of study and/or conventional cigarettes they have smoked each day. Cigarettes smoked (both usual brand and experimental) in a given week were summed over the first 7 reported days. If the number of cigarettes smoked was missing for 1 day, the average of the other days in that week was used in its place and reported as total number of cigarettes per week.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 18-64 years old

• Regular smokers (10+ cigarettes per day and has done so for the last year)

• Inhaling when smoking

• Carbon monoxide (CO) > 8 ppm

Exclusion Criteria:

• In the past year, suffered from any cardiovascular disease such as: heart disease, heart attack, stroke or angina, any respiratory diseases such as chronic bronchitis or chronic obstructive pulmonary disease (COPD), any type of cancer

• Currently suffering from Bipolar Disorder, General Anxiety Disorder, Schizophrenia, or a major depressive episode

• Taken any of the following drugs more than twice per week during the past month: antidepressants, anti-anxiety medications.

• Consumed more than 15 alcoholic drinks per week for the past month

• Pregnant, trying to become pregnant, or lactating (assessed by self-report)

• In the past 3 months, used nicotine replacement products (like the patch, gum, or inhaler), or the medications bupropion varenicline

• Currently trying or planning to reduce or quit tobacco use in the next 30 days

• Used other forms of tobacco 10 or more days in the past 30 days

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55414

Sponsors and Collaborators

• University of Minnesota

Investigators

• Principal Investigator: Dorothy Hatsukami, Ph.D., Tobacco Use Research Program, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT01568905
• Other Study ID Numbers: 1012M94314
• First Posted: Apr 2, 2012
• Last Update Posted: Nov 1, 2019
• Last Verified: Oct 1, 2019

• Keywords provided by University of Minnesota: smoker; smoking; nicotine levels; tobacco; nicotine
• Additional relevant MeSH terms: Nicotine

Study Results

Participant Flow

Arm/Group Title	Arm 1 Low Level Nicotine Cigarette	Arm 2 Intermediate Nicotine Level Cigarette	Arm 3 High Level Nicotine Cigarette
Arm/Group Description	Low level nicotine cigarette: smoke the study cigarette exclusively for one week	Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week	High level nicotine cigarette: smoke the study cigarette exclusively for one week
Period Title: Overall Study
STARTED	13	11	12
COMPLETED	12	11	12
NOT COMPLETED	1	0	0

Baseline Characteristics

Arm/Group Title	Arm 1 Low Level Nicotine Cigarette	Arm 2 Intermediate Nicotine Level Cigarette	Arm 3 High Level Nicotine Cigarette	Total
Arm/Group Description	Low level nicotine cigarette (0.400 mg/g; menthol 0.405 mg/g): smoke the study cigarette exclusively for one week	Intermediate nicotine level cigarette (5.86 mg/g menthol 5.87 mg/g): smoke the study cigarette exclusively for one week	High level nicotine cigarette (10.4 mg/g; menthol: 12.3): smoke the study cigarette exclusively for one week	Total of all reporting groups
Overall Participants	12	11	12	35
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	12 100%	11 100%	12 100%	35 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.0 (12.4)	32.7 (10.8)	43.6 (9.6)	37.9 (11.6)
Sex: Female, Male (Count of Participants)
Female	8 66.7%	7 63.6%	5 41.7%	20 57.1%
Male	4 33.3%	4 36.4%	7 58.3%	15 42.9%
Region of Enrollment (participants) [Number]
United States	12 100%	11 100%	12 100%	35 100%
Menthol (participants) [Number]
Menthol	4 33.3%	3 27.3%	4 33.3%	11 31.4%
Non Menthol	8 66.7%	8 72.7%	8 66.7%	24 68.6%
Cigarettes per day (Cigarettes per day) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Cigarettes per day]	16.8 (5.1)	16.1 (3.5)	18.7 (4.3)	17.2 (4.4)

Outcome Measures

1. Primary Outcome

Title	Change in UrineTotal Nicotine Equivalent (TNE) Between Baseline and Week 1
Description	Two urine TNE levels are taken, one at baseline and one at week 1, to assess TNE levels for nicotine exposure. TNE is the sum of nicotine, cotinine, trans 3'-hydroxycotinine and their respective glucuronide conjugates. Values reported in nmols/ml.
Time Frame	Second Visit (Week 1) minus Baseline (Day 1)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1 Low Level Nicotine Cigarette	Arm 2 Intermediate Nicotine Level Cigarette	Arm 3 High Level Nicotine Cigarette
Arm/Group Description	Low level nicotine cigarette: smoke the study cigarette exclusively for one week	Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week	High level nicotine cigarette: smoke the study cigarette exclusively for one week
Measure Participants	12	11	12
Mean (Standard Error) [nmols/ml]	-16.2 (5.0)	-7.6 (4.7)	1.3 (4.4)

2. Secondary Outcome

Title	Responses on Modified Cigarette Evaluation Scale
Description	Modified Cigarette Evaluation Scale [CES] is a 100 mm visual analog scale (0=not at all or very little nicotine; 100=extremely or high in nicotine) of 20 questions assessing different dimensions of responses to usual brand cigarettes (e.g., psychological reward, satisfaction and aversiveness) and includes additional 5 point likert-type questions (definitely agree to definitely disagree) on perceptions of satisfaction and willingness to use the product. Results satisfaction subscale.
Time Frame	Baseline usual brand cigarettes (Day 1) compared to when using study cigarettes (Week 1)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1 Low Level Nicotine Cigarette	Arm 2 Intermediate Nicotine Level Cigarette	Arm 3 High Level Nicotine Cigarette
Arm/Group Description	Low level nicotine cigarette: smoke the study cigarette exclusively for one week	Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week	High level nicotine cigarette: smoke the study cigarette exclusively for one week
Measure Participants	12	11	12
Mean (Standard Error) [units on a scale]	36.8 (4.1)	54.1 (4.1)	61.4 (4.1)

3. Secondary Outcome

Title	Change From Baseline of Perceived Health Risk Scale Response to Test Cigarettes
Description	Questionnaire: Perceived Health Risk Scale asks subjects to rate their perception of health risks for lung cancer for the study product to which they have been randomly assigned. This is a 100 mm visual analog scale; 0=very low risk of disease, 100=very high risk of disease.
Time Frame	Baseline (Day 1) Compared to Second Visit (Week 1)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1 Low Level Nicotine Cigarette	Arm 2 Intermediate Nicotine Level Cigarette	Arm 3 High Level Nicotine Cigarette
Arm/Group Description	Low level nicotine cigarette: smoke the study cigarette exclusively for one week	Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week	High level nicotine cigarette: smoke the study cigarette exclusively for one week
Measure Participants	12	11	12
Mean (Standard Error) [units on a scale]	56.6 (4.6)	66.7 (4.6)	68.3 (4.6)

4. Secondary Outcome

Title	Comparison of Number of Cigarettes Smoked
Description	Subjects were given a daily diary to collect the number of study and/or conventional cigarettes they have smoked each day. Cigarettes smoked (both usual brand and experimental) in a given week were summed over the first 7 reported days. If the number of cigarettes smoked was missing for 1 day, the average of the other days in that week was used in its place and reported as total number of cigarettes per week.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1 Low Level Nicotine Cigarette	Arm 2 Intermediate Nicotine Level Cigarette	Arm 3 High Level Nicotine Cigarette
Arm/Group Description	Low level nicotine cigarette: smoke the study cigarette exclusively for one week	Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week	High level nicotine cigarette: smoke the study cigarette exclusively for one week
Measure Participants	12	11	12
Mean (Standard Deviation) [cigarettes per week]	92.1 (15.9)	112.8 (49.4)	157.6 (15.2)

Adverse Events

Time Frame	1 week
Arm/Group Title	Arm 1 Low Level Nicotine Cigarette		Arm 2 Intermediate Nicotine Level Cigarette		Arm 3 High Level Nicotine Cigarette
Arm/Group Description	Low level nicotine cigarette: smoke the study cigarette exclusively for one week		Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week		High level nicotine cigarette: smoke the study cigarette exclusively for one week
All Cause Mortality
	Arm 1 Low Level Nicotine Cigarette		Arm 2 Intermediate Nicotine Level Cigarette		Arm 3 High Level Nicotine Cigarette
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1 Low Level Nicotine Cigarette		Arm 2 Intermediate Nicotine Level Cigarette		Arm 3 High Level Nicotine Cigarette
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/11 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Arm 1 Low Level Nicotine Cigarette		Arm 2 Intermediate Nicotine Level Cigarette		Arm 3 High Level Nicotine Cigarette
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/11 (0%)		0/12 (0%)

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.