Tobacco Use Disorder
Conditions
Brief summary
The purpose of this study is to determine if in smokers of menthol cigarettes, switching to non-menthol cigarettes prior to a cessation attempt results in greater cessation success than attempting to quit without first switching
Interventions
OTHERswitch to non-menthol cigarettes prior to cessation attempt
OTHERcontinue smoking menthol cigarettes prior to cessation attempt
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Self identify as African American * smoke primarily menthol cigarettes * be between the ages of 18 and 64 * smoke a minimum number of cigarettes per day * express an interest in quitting smoking
Exclusion criteria
* current unstable medical / psychiatric condition * regular use any form of nicotine or tobacco other than cigarettes * are pregnant or breast feeding The investigators will evaluate if there are other reasons why someone may not be eligible to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Lapse | 6 months | Time from smoking cessation until first lapse (i.e. a cigarette is smoked) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Relapse | 6 months | Days from the quit attempt until the first of seven consecutive smoking days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Continue Smoking Menthol Cigarettes Menthol cigarette smokers continue to smoke menthol cigarettes for a four week period before attempting to quit smoking
continue smoking menthol cigarettes prior to cessation attempt | 60 |
| Switch to Non-menthol Cigarettes Menthol cigarette smokers switch to non-menthol cigarettes for a four week period before attempting to quit smoking
switch to non-menthol cigarettes prior to cessation attempt | 62 |
| Total | 122 |
Baseline characteristics
| Characteristic | Continue Smoking Menthol Cigarettes | Total | Switch to Non-menthol Cigarettes |
|---|---|---|---|
| Age, Continuous | 47 years STANDARD_DEVIATION 10 | 46 years STANDARD_DEVIATION 11 | 45 years STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 60 Participants | 122 Participants | 62 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 | 60 participants | 122 participants | 62 participants |
| Sex: Female, Male Female | 22 Participants | 45 Participants | 23 Participants |
| Sex: Female, Male Male | 38 Participants | 77 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 62 |
| other Total, other adverse events | 0 / 60 | 0 / 62 |
| serious Total, serious adverse events | 0 / 60 | 0 / 62 |
Outcome results
Primary
Time to Lapse
Time from smoking cessation until first lapse (i.e. a cigarette is smoked)
Time frame: 6 months
Population: Participants who attended the quit day visit
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Continue Smoking Menthol Cigarettes | Time to Lapse | 1.07 days |
| Switch to Non-menthol Cigarettes | Time to Lapse | 2.55 days |
Comparison: Hazard ratio for time to lapse to smoking in the group switched to non-menthol cigarettes relative to the group continuing to smoke menthol cigarettes95% CI: [0.55, 1.22]
Secondary
Time to Relapse
Days from the quit attempt until the first of seven consecutive smoking days
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Continue Smoking Menthol Cigarettes | Time to Relapse | 7 days |
| Switch to Non-menthol Cigarettes | Time to Relapse | 42 days |
Comparison: Hazard ratio for time to relapse to smoking in the group switched to non-menthol cigarettes relative to the group continuing to smoke menthol cigarettes95% CI: [0.42, 1.06]