Trial Outcomes & Findings for Menominee Stop Tobacco Abuse Renew Tradition Study (NCT NCT01083654)

Last Updated: 2016-06-17

Results Overview

Self-reported abstinence (versus smoking) during the past 7 days at the 6-month follow-up time-point, verified by exhaled breath carbon monoxide (CO) measurement (\< 10 parts per million CO is indicative of no smoking).

Recruitment status

COMPLETED

Study phase

Target enrollment

103 participants

Primary outcome timeframe

6 months

Results posted on

2016-06-17

Participant Flow

Participants were recruited from February 22, 2010, to May 26, 2011 at the Menominee Tribal Clinic (MTC). The MTC Wellness Director or designee screened potential participants (adult American Indian smokers). Informed consent and HIPAA authorization were obtained at the Enrollment Visit.

Participant milestones

Participant milestones
Measure	Standard Treatment Counseling Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively). Standard Treatment Counseling: Standard Treatment Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by Ms. Fossum (an enrolled member of the Menominee Tribe) but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling. In other w	Culturally-Tailored Treatment The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively). Culturally-Tailored Treatment: The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol
Overall Study STARTED	53	50
Overall Study COMPLETED	53	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Menominee Stop Tobacco Abuse Renew Tradition Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Treatment Counseling n=53 Participants Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively). ST Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by an enrolled member of the Menominee Tribe but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling.	Culturally-Tailored Treatment n=50 Participants The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively). The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol of long life)	Total n=103 Participants Total of all reporting groups
Age, Continuous	39.4 years STANDARD_DEVIATION 13.5 • n=5 Participants	40.1 years STANDARD_DEVIATION 12.7 • n=7 Participants	39.8 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	30 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	53 Participants n=5 Participants	50 Participants n=7 Participants	103 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	53 participants n=5 Participants	50 participants n=7 Participants	103 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Standard Treatment Counseling n=53 Participants Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively). Standard Treatment Counseling: Standard Treatment Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by Ms. Fossum (an enrolled member of the Menominee Tribe) but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling. In other w	Culturally-Tailored Treatment n=50 Participants The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of four sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively). Culturally-Tailored Treatment: The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol
7-day Point-prevalence Smoking Abstinence	12 Number of abstinent participants	7 Number of abstinent participants

Adverse Events

Standard Treatment Counseling

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Culturally-Tailored Treatment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Standard Treatment Counseling n=53 participants at risk Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively). Standard Treatment Counseling: Standard Treatment Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by Ms. Fossum (an enrolled member of the Menominee Tribe) but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling. In other w	Culturally-Tailored Treatment n=50 participants at risk The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of four sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively). Culturally-Tailored Treatment: The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol
Gastrointestinal disorders Stomach pain	1.9% 1/53 • Number of events 1 • 12 weeks Medication adverse events were assessed during the 12 weeks of medication use.	0.00% 0/50 • 12 weeks Medication adverse events were assessed during the 12 weeks of medication use.
Psychiatric disorders Change in mood	0.00% 0/53 • 12 weeks Medication adverse events were assessed during the 12 weeks of medication use.	2.0% 1/50 • Number of events 1 • 12 weeks Medication adverse events were assessed during the 12 weeks of medication use.
Gastrointestinal disorders Nausea	0.00% 0/53 • 12 weeks Medication adverse events were assessed during the 12 weeks of medication use.	2.0% 1/50 • Number of events 1 • 12 weeks Medication adverse events were assessed during the 12 weeks of medication use.

Additional Information

Stevens S. Smith, Ph.D.

University of Wisconsin School of Medicine and Public Health

Phone: 608-262-7563

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place