Comparison Across Treatment Conditions to Reduce Smokeless Tobacco Use

• Sponsor: University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT00218296
• Collaborator: (none)
• Enrollment: 332
• Location: 1
• Arms: 2
• Duration (Months): 26
• Patients Per Site Per Month: 12.8

Study Details

Study Description

Brief Summary

Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has health risks associated with its use. While treatment programs that focus on stopping tobacco use may be effective, past research has shown that interventions that specifically focus on reducing tobacco use may be equally effective and may motivate individuals to eventually quit using tobacco. This study will compare the effectiveness of a ST reduction treatment program versus a usual tobacco cessation treatment program (immediate cessation) for reducing tobacco use in ST users.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Use Disorder	Drug: Usual Care Group; Other: Reduction Group	Phase 2

Detailed Description

Individuals who use ST are at increased risk for cancer or dying from cardiovascular disease. Other long-term effects include tooth abrasion, gum recession, and loss of bone in the jaw. Many individuals who use ST recognize the health risks associated with ST, but either do not want to quit or feel that it is impossible to quit. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting or as a treatment endpoint. By participating in a tobacco reduction program, these individuals may be motivated to eventually stop using tobacco altogether. The purpose of this study is to compare a ST reduction treatment program versus a standard tobacco cessation treatment program (immediate cessation) for reducing tobacco use in ST users.

This study will enroll regular users of ST. Participants will be randomly assigned to either a tobacco reduction program or to usual care, a standard tobacco cessation program during the first telephone contact. At the first clinic visit, participants assigned to the tobacco Reduction Group will replace their usual brand of ST with one of two options: an ST brand with less nicotine or nicotine lozenge. Participants will be encouraged to reduce their nicotine intake by at least 50% the first two weeks and encouraged to further reduce their nicotine intake in the following 4 weeks. Participants assigned to the Usual Care Group will be advised to quit and will be asked to set a quit date within two weeks. Telephone counseling, ideas on methods for sustaining cessation, and a self-help manual will also be provided along with a 2 week supply of nicotine patches. Study visits will occur at 2, 4, 8, 12, 26, and 32 (for reduction group) weeks. Outcome assessments will include vital signs, physiological measures related to tobacco use, levels of nicotine reduction, tobacco use status, and measures of motivation and self-efficacy to quit.

Study Design

• Study Type: Interventional
• Actual Enrollment: 332 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment of Smokeless Tobacco Users
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Usual Care Group Usual care for cessation with immediate quit date scheduled and two weeks of nicotine patch supplied.	Drug: Usual Care Group; Nicotine replacement therapy; Other Names: 21 mg Nicotine Patch Nicoderm
Experimental: Reduction Group Reduction in nicotine exposure for 6 weeks prior to quit date using medicinal nicotine lozenge or reduced nicotine smokeless tobacco.	Other: Reduction Group; Subject selects preferred method for reduction.; Other Names: Commit Nicotine Lozenge or Reduced nicotine smokeless tobacco products (Skoal, Skoal Bandits)

Outcome Measures

Primary Outcome Measures

1. Percent Abstinent From Tobacco at Week 12 (7 Day Point Prevalence) [12 weeks]

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

2. Percent Prolonged Abstinence From Tobacco at Week 12 [12 weeks]

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

3. Percent Abstinent From Tobacco at Week 26 (7 Day Point Prevalence) [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)

4. Percent Prolonged Abstinence From Tobacco at Week 26 [26 weeks]

   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).

5. Percent Abstinent From Tobacco at Week 32 (7 Day Point Prevalence) [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).

6. Percent Prolonged Abstinence From Tobacco at Week 32 [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• No interest in stopping ST use within 90 days of study entry

• Daily use of ST in the 6 months prior to study entry

Exclusion Criteria:

• Current use of tobacco or nicotine products, other than ST

• Current unstable medical and mental health conditions

• Use of any medication that may affect tobacco use or be affected by a reduction in tobacco use

• Pregnant or breastfeeding

Contacts and Locations

Locations

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

Sponsors and Collaborators

• University of Minnesota

Investigators

• Principal Investigator: Dorothy Hatsukami, PhD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Schiller KR, Luo X, Anderson AJ, Jensen JA, Allen SS, Hatsukami DK. Comparing an immediate cessation versus reduction approach to smokeless tobacco cessation. Nicotine Tob Res 2012.

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT00218296
• Other Study ID Numbers: NIDA-14404-4; R01-DA14404-4; DPMCDA
• First Posted: Sep 22, 2005
• Last Update Posted: Oct 16, 2017
• Last Verified: Sep 1, 2017

• Keywords provided by University of Minnesota: Nicotine Dependence; Tobacco Dependence
• Additional relevant MeSH terms: Tobacco Use Disorder; Lobeline; Nicotine

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 3/2007 through 5/2008.
Pre-assignment Detail	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.

Arm/Group Title	Usual Care Group	Reduction Group
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	163	169
Attended Visti	97	102
COMPLETED	52	48
NOT COMPLETED	111	121

Baseline Characteristics

Arm/Group Title	Usual Care Group	Reduction Group	Total
Arm/Group Description	Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.	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 of all reporting groups
Overall Participants	97	102	199
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	97 100%	102 100%	199 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.4 (8.4)	35.1 (8.6)	34.8 (8.5)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	97 100%	102 100%	199 100%
Region of Enrollment (participants) [Number]
United States	97 100%	102 100%	199 100%

Outcome Measures

1. Primary Outcome

Title	Percent Abstinent From Tobacco at Week 12 (7 Day Point Prevalence)
Description	No tobacco use 7 days prior to Week 12 verified by biomarkers (urine, cotinine and CO)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Intent to treat

Arm/Group Title	Usual Care Group	Reduction Group
Arm/Group Description	Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.	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.
Measure Participants	163	169
Number [percentage of randomized]	31	17

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Group, Reduction Group
	Comments	The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	Chi-squared
	Comments	There were no adjustments in the analysis.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.51
	Confidence Interval	(2-Sided) 95%; 0.26 to 0.99
	Parameter Dispersion	Type: Value:
	Estimation Comments	The reference group for the odds ratio estimate is the usual care condition, i.e., the immediate cessation condition.

2. Primary Outcome

Title	Percent Prolonged Abstinence From Tobacco at Week 12
Description	Continuous tobacco cessation from quit date through Week 12 verified by biomarkers (urine, cotinine and CO)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care Group	Reduction Group
Arm/Group Description	Usual Care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the 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 using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
Measure Participants	163	169
Number [percentage of randomized]	13	4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Group, Reduction Group
	Comments	The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.019
	Comments
	Method	Chi-squared
	Comments	There were no adjustments in the analysis.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.28
	Confidence Interval	(2-Sided) 95%; 0.07 to 0.83
	Parameter Dispersion	Type: Value:
	Estimation Comments	The reference group for the odds ratio estimate is the Usual Care condition, i.e., the immediate cessation condition.

3. Primary Outcome

Title	Percent Abstinent From Tobacco at Week 26 (7 Day Point Prevalence)
Description	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)
Time Frame	26 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care Group	Reduction Group
Arm/Group Description	Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.	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.
Measure Participants	163	169
Number [percentage of randomized]	20	10

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Group, Reduction Group
	Comments	The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	Chi-squared
	Comments	There were no adjustments in the analysis.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.42
	Confidence Interval	(2-Sided) 95%; 0.18 to 0.94
	Parameter Dispersion	Type: Value:
	Estimation Comments	The reference group for the odds ratio estimate is the usual care condition, i.e., the immediate cessation condition.

4. Primary Outcome

Title	Percent Prolonged Abstinence From Tobacco at Week 26
Description	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).
Time Frame	26 weeks

Outcome Measure Data

Analysis Population Description

Intent to treat

Arm/Group Title	Usual Care Group	Reduction Group
Arm/Group Description	Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.	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.
Measure Participants	163	169
Number [percentage of randomized]	11	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Group, Reduction Group
	Comments	The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.002
	Comments
	Method	Chi-squared
	Comments	There were no adjustments in the analysis.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.09
	Confidence Interval	(2-Sided) 95%; 0.004 to 0.48
	Parameter Dispersion	Type: Value:
	Estimation Comments	The reference group for the odds ratio estimate is the Usual Care Condition, i.e., the immediate cessation condition.

5. Primary Outcome

Title	Percent Abstinent From Tobacco at Week 32 (7 Day Point Prevalence)
Description	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).
Time Frame	32 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care Group	Reduction Group
Arm/Group Description	Usual Care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the 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 using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
Measure Participants	163	169
Number [percentage of randomized]	20	11

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Group, Reduction Group
	Comments	The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.056
	Comments
	Method	Chi-squared
	Comments	There were no adjustments in the analysis.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.47
	Confidence Interval	(2-Sided) 95%; 0.20 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments	The reference group for the odds ratio estimate is the Usual Care Condition, i.e., the immediate cessation condition.

6. Primary Outcome

Title	Percent Prolonged Abstinence From Tobacco at Week 32
Description	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).
Time Frame	32 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care Group	Reduction Group
Arm/Group Description	Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.	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.
Measure Participants	163	169
Number [percentage of randomized]	11	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Group, Reduction Group
	Comments	The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments	There were no adjustments in the analysis.
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.09
	Confidence Interval	(2-Sided) 95%; 0.004 to 0.48
	Parameter Dispersion	Type: Value:
	Estimation Comments	The reference group for the odds ratio estimate is the Usual Care Condition, i.e., the immediate cessation condition.

Adverse Events

Time Frame	6 weeks
Arm/Group Title	Usual Care Group		Reduction Group
Arm/Group Description	Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.		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.
All Cause Mortality
	Usual Care Group		Reduction Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Usual Care Group		Reduction Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/97 (0%)		0/102 (0%)
Other (Not Including Serious) Adverse Events
	Usual Care Group		Reduction Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	46/97 (47.4%)		25/102 (24.5%)
General disorders
Sleep Disturbance	19/97 (19.6%)	19	3/102 (2.9%)	3
Dry Mouth	4/97 (4.1%)	4	9/102 (8.8%)	12
Headache	8/97 (8.2%)	8	13/102 (12.7%)	18
Redness at Patch Site	8/97 (8.2%)	8	0/102 (0%)	0
Musculoskeletal and connective tissue disorders
Muscle Aches	6/97 (6.2%)	7	0/102 (0%)	0
Skin and subcutaneous tissue disorders
Pruritus	21/97 (21.6%)	22	0/102 (0%)	0

Limitations/Caveats

Sample size was limited.

More Information

Certain Agreements

All Principal Investigators ARE 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.