Contraception, Nicotine Dependence
Conditions
Brief summary
The investigators aim to (1) examine the association between levels of progesterone (Prog), allopregnanolone (Allo), and the estradiol/progesterone (E2/P) ratios with smoking-related symptomatology during ad libitum smoking and (2) determine the association between Prog, Allo, and E2/P with the changes in smoking-related symptomatology and response to nicotine following overnight abstinence
Detailed description
The sample population will consist of oral contraceptive users, both low and high dose levels of exogenous progesterone with a consistent dose of exogenous estrogen. Participants will complete data collection procedures including providing saliva (cortisol to measure stress), urine (cotinine and 3-Hydroxycotinine to measure nicotine exposure), and blood (progesterone, allopregnanolone, and estradiol) samples, as well as ecological momentary assessments (EMA) daily for seven-days. Participants will also complete a 3-hour smoking topography lab session after overnight abstinence and a 4.5-hour nicotine nasal spray lab session after a 14-hour abstinence. These sessions will contain a nicotine challenge via smoking a cigarette or nasal spray with timed-series physiological, subjective, and behavioral responses.
Interventions
DRUGLow-dose Progesterone
The low progesterone dose is seven days of placebo Tri-sprintec + placebo generic Prometrium twice a day (7AM and 7PM).
DRUGHigh-dose Progesterone
The high progesterone dose is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice a day (7AM and 7PM).
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* currently taking oral contraceptives * English fluency * Ability to provide informed consent
Exclusion criteria
* use of progestin only contraceptive * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Smoking Urges | after overnight abstinence on day 8 | Questionnaire on Smoking Urges-Brief (QSU-Brief): This ten-item version of the original form (QSU) was developed by Tiffany and Drobes and has an excellent level of reliability (α = .97). Total QSU-Brief. Scores can average between 1-7. A higher scores means more urges. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Positive and Negative Affect Scale Following Overnight Abstinence | after overnight abstinence on day 8 | Positive and Negative Affect Scale (PANAS): Participants rate 20 words associated with positive or negative affect using a five-point Likert-type scale. This scale has been shown to have high internal consistency. Positive PANAS scores can range from 10-50. A higher score means greater positive affect. Negative PANAS score can range from 10-50. A higher score means greater negative affect. |
| Change in Cohen Perceived Stress Scale | after overnight abstinence on day 8 | Cohen Perceived Stress Scale (PSS): This ten-item questionnaire has been validated in a variety of populations including pregnant and postpartum women. It uses five-items to assess ten questions resulting in two factors negative feelings and inability to handle stress. It has high internal reliability (alpha = 0.75). Score range from 0-56. A higher score means more perceived stress. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants at baseline | 70 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Treatment Period 1 | Adverse Event | 2 | 3 |
| Treatment Period 1 | Lost to Follow-up | 12 | 8 |
| Treatment Period 1 | transporation | 1 | 0 |
| Treatment Period 1 | unable to remain smoke free overnight | 10 | 6 |
| Treatment Period 2 | Lost to Follow-up | 1 | 2 |
| Treatment Period 2 | unable to remain smoke free overnight | 3 | 4 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants |
| Age, Continuous | 25 years |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black | 12 Participants |
| Race/Ethnicity, Customized Hawaiian/Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Mixed Race | 9 Participants |
| Race/Ethnicity, Customized Native American | 5 Participants |
| Race/Ethnicity, Customized White | 41 Participants |
| Region of Enrollment United States | 70 participants |
| Sex: Female, Male Female | 70 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 36 |
| other Total, other adverse events | 19 / 34 | 17 / 36 |
| serious Total, serious adverse events | 0 / 34 | 0 / 36 |
Outcome results
Primary
Change in Smoking Urges
Questionnaire on Smoking Urges-Brief (QSU-Brief): This ten-item version of the original form (QSU) was developed by Tiffany and Drobes and has an excellent level of reliability (α = .97). Total QSU-Brief. Scores can average between 1-7. A higher scores means more urges.
Time frame: after overnight abstinence on day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low-Dose Contraceptive | Change in Smoking Urges | 5.0 score on a scale | Standard Deviation 1.4 |
| High-Dose Contraceptive | Change in Smoking Urges | 5.5 score on a scale | Standard Deviation 2.1 |
Secondary
Change in Cohen Perceived Stress Scale
Cohen Perceived Stress Scale (PSS): This ten-item questionnaire has been validated in a variety of populations including pregnant and postpartum women. It uses five-items to assess ten questions resulting in two factors negative feelings and inability to handle stress. It has high internal reliability (alpha = 0.75). Score range from 0-56. A higher score means more perceived stress.
Time frame: after overnight abstinence on day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low-Dose Contraceptive | Change in Cohen Perceived Stress Scale | 14 score on a scale | Standard Deviation 4.3 |
| High-Dose Contraceptive | Change in Cohen Perceived Stress Scale | 15 score on a scale | Standard Deviation 3.8 |
Secondary
Change in Positive and Negative Affect Scale Following Overnight Abstinence
Positive and Negative Affect Scale (PANAS): Participants rate 20 words associated with positive or negative affect using a five-point Likert-type scale. This scale has been shown to have high internal consistency. Positive PANAS scores can range from 10-50. A higher score means greater positive affect. Negative PANAS score can range from 10-50. A higher score means greater negative affect.
Time frame: after overnight abstinence on day 8
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Low-Dose Contraceptive | Change in Positive and Negative Affect Scale Following Overnight Abstinence | Positive Affect | 26.21 score on a scale |
| Low-Dose Contraceptive | Change in Positive and Negative Affect Scale Following Overnight Abstinence | Negative Affect | 17.01 score on a scale |
| High-Dose Contraceptive | Change in Positive and Negative Affect Scale Following Overnight Abstinence | Positive Affect | 24.09 score on a scale |
| High-Dose Contraceptive | Change in Positive and Negative Affect Scale Following Overnight Abstinence | Negative Affect | 15.41 score on a scale |