Smoking
Conditions
Keywords
Smoking, Smoking cessation
Brief summary
The purpose of this community-based study is to evaluate the effectiveness of a culturally-tailored smoking cessation treatment for American Indian (AI) smokers as compared to standard evidence-based cessation treatment (not culturally-tailored).
Detailed description
Smoking is the leading preventable cause of illness and death. American Indians (AIs) have the highest rate of smoking but very little research has addressed how to help AIs quit smoking. AIs also suffer health disparities related to the addictive use of commercial tobacco. Many AIs also use natural tobacco for ceremonial purposes in addition to using commercial tobacco in an addictive manner. This study will add important new knowledge about how best to help AI smokers quit smoking (addictive use of commercial tobacco) and this is expected to help reduce the prevalence of smoking and smoking-related illness in AI communities. The Menominee Smoking Cessation Clinical Trial is a community-based study designed to evaluate a culturally-appropriate, evidence-based smoking cessation intervention for AI smokers. This project joins together collaborators at the University of Wisconsin Center for Tobacco Research and Intervention (UW-CTRI; PI Dr. Stevens Smith; smoking cessation expertise), the UW Carbone Comprehensive Cancer Center (UWCCC), the University of Wisconsin-Milwaukee (UWM; Dr. Leah Arndt; qualitative analysis expertise), and the Menominee Tribal Clinic (MTC; Wellness Director Mr. Mark Caskey; MTC Director Mr. Jerry Waukau, an enrolled member of the Menominee Tribe; and Ms. Jodi Fossum, an enrolled member of the Menominee Tribe) that serves Menominee and other AI patients. The study will randomize 150 AI smokers to two treatment conditions: (1) a standard evidence-based smoking cessation treatment condition (FDA-approved varenicline for 12 weeks + 4 counseling sessions), and, (2) a culturally-tailored smoking cessation treatment condition consisting of the standard treatment (FDA-approved varenicline for 12 weeks + 4 counseling sessions) plus culturally-appropriate treatment elements. Follow-up will be conducted at 3 and 6 months post-quit to assess smoking status and other study outcomes. We also plan to collect and analyze qualitative data (this aspect of the study will be led by Dr. Arndt) to learn more about the process and factors associated with cessation of commercial tobacco in American Indians including cultural factors.
Interventions
BEHAVIORALStandard 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 words, the counseling in the Standard Treatment will be similar to the kind of evidence-based counseling offered to other smokers regardless of race or ethnicity.
BEHAVIORALCulturally-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 of long life)
Sponsors
University of Wisconsin, Milwaukee
Menominee Indian Tribe of Wisconsin
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. at least 18 years of age 2. must smoke cigarettes 3. eligible to receive health care services at the Menominee Tribal Clinic (i.e., must be an enrolled member of a federally-recognized American Indian Tribe) 4. primary care provider (M.D. or Nurse Practitioner) is at the Menominee Tribal Clinic 5. must be medically able and willing to take varenicline
Exclusion criteria
1. end-stage renal disease with hemodialysis 2. any prior suicide attempts 3. current or recent (past 12 months) suicidal ideation 4. currently pregnant or breastfeeding 5. unwilling to use appropriate methods of birth control while taking study medication and for 1 month after discontinuing study medication 6. primary care provider (PCP) determines that the individual should not take varenicline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-day Point-prevalence Smoking Abstinence | 6 months | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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).
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. | 53 |
| 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).
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) | 50 |
| Total | 103 |
Baseline characteristics
| Characteristic | Standard Treatment Counseling | Total | Culturally-Tailored Treatment |
|---|---|---|---|
| Age, Continuous | 39.4 years STANDARD_DEVIATION 13.5 | 39.8 years STANDARD_DEVIATION 13.1 | 40.1 years STANDARD_DEVIATION 12.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 53 Participants | 103 Participants | 50 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 53 participants | 103 participants | 50 participants |
| Sex: Female, Male Female | 34 Participants | 64 Participants | 30 Participants |
| Sex: Female, Male Male | 19 Participants | 39 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 53 | 2 / 50 |
| serious Total, serious adverse events | 0 / 53 | 0 / 50 |
Outcome results
Primary
7-day Point-prevalence Smoking Abstinence
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).
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Treatment Counseling | 7-day Point-prevalence Smoking Abstinence | 12 Number of abstinent participants |
| Culturally-Tailored Treatment | 7-day Point-prevalence Smoking Abstinence | 7 Number of abstinent participants |
p-value: 0.26295% CI: [0.2, 1.55]Regression, Logistic