Tobacco Use Disorder
Conditions
Keywords
Biomarkers of exposure, Compensatory smoking, Nicotine dependence, Reduced nicotine cigarettes, Tobacco withdrawal, Women, Pregnancy, Health disparities, Vulnerable populations
Brief summary
Study 2 will evaluate the effects of extended exposure to cigarettes with varying levels of nicotine in pregnant smokers who have less than an Associate's degree. This study will be limited to two conditions: usual brand vs. 0.4 mg nicotine/g tobacco. After a baseline period in which daily smoking rate and other baseline assessments are completed, participants will be randomly (by chance) assigned to either their usual brand or the very low nicotine content condition and followed for 12 weeks.
Detailed description
Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.
Interventions
Cigarettes containing 0.4 mg nicotine/g tobacco
Sponsors
University of Vermont
National Institute on Drug Abuse (NIDA)
Food and Drug Administration (FDA)
University of Kentucky
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes
Inclusion criteria
* Female * Ages 18-44 years * Gestational age ≤ 25 weeks
Exclusion criteria
* Male * Under 18 years old * Over 44 years old * Gestational age \> 25 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Cigarettes Per Day | 12 weeks |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSarah H. Heil
University of Vermont
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Very Low Nicotine Content Cigarettes Very low nicotine content cigarettes: Cigarettes containing 0.4 mg nicotine/g tobacco | 16 |
| Usual Brand Participant's usual brand cigarettes | 14 |
| Total | 30 |
Baseline characteristics
| Characteristic | Very Low Nicotine Content Cigarettes | Usual Brand | Total |
|---|---|---|---|
| Age, Continuous | 28.31 Years STANDARD_DEVIATION 4.8 | 27.57 Years STANDARD_DEVIATION 4.77 | 27.97 Years STANDARD_DEVIATION 4.72 |
| Cigarettes per day | 19.19 Cigarettes per day STANDARD_DEVIATION 8.15 | 16.21 Cigarettes per day STANDARD_DEVIATION 8.05 | 17.80 Cigarettes per day STANDARD_DEVIATION 8.1 |
| Cigarettes per day pre-pregnancy | 18.38 Cigarettes per day STANDARD_DEVIATION 5.91 | 23.93 Cigarettes per day STANDARD_DEVIATION 14.08 | 20.97 Cigarettes per day STANDARD_DEVIATION 10.72 |
| Gestational age at screening | 11.94 Weeks STANDARD_DEVIATION 4.99 | 13.43 Weeks STANDARD_DEVIATION 6.26 | 12.63 Weeks STANDARD_DEVIATION 5.57 |
| Race/Ethnicity, Customized Non-Latino other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Non-Latino White | 15 Participants | 14 Participants | 29 Participants |
| Sex: Female, Male Female | 16 Participants | 14 Participants | 30 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 14 |
| other Total, other adverse events | 11 / 16 | 13 / 14 |
| serious Total, serious adverse events | 0 / 16 | 1 / 14 |
Outcome results
Primary
Total Cigarettes Per Day
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Very Low Nicotine Content Cigarettes | Total Cigarettes Per Day | 16.31 Cigarettes per day | Standard Error 2.63 |
| Usual Brand | Total Cigarettes Per Day | 18.36 Cigarettes per day | Standard Error 2.32 |