Trial Outcomes & Findings for Smoking, Sex Hormones, and Pregnancy (NCT NCT01811225)
NCT ID: NCT01811225
Last Updated: 2020-11-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
95 participants
Primary outcome timeframe
after overnight abstinence on day 8
Results posted on
2020-11-13
Participant Flow
Participant milestones
| Measure |
Low-Dose Contraceptive, Then High-Dose
Females, 18-35 years old, non-pregnant, using oral contraceptive for at least the last 3 months before enrollment will be given Tri-Sprintec and generic Prometrium.
Participants in this arm will begin with the "low" dose progesterone, which is seven days of placebo Tri-sprintec + placebo generic Prometrium twice daily (7AM and 7PM). Then participants in this arm will move to the "high" dose progesterone, which is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice daily (7AM and 7PM).
|
High-Dose Contraceptive, Then Low-Dose
Females, 18-35 years old, non-pregnant, using oral contraceptive for at least the last 3 months before enrollment will be given Tri-Sprintec and generic Prometrium.
Participants in this arm will begin with the "high" progesterone dose, which is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice daily (7AM and 7PM). Then participants in this arm will move to the "low" dose progesterone, which is seven days of placebo Tri-sprintec + placebo generic Prometrium twice daily (7AM and 7PM).
|
|---|---|---|
|
Treatment Period 1
STARTED
|
49
|
46
|
|
Treatment Period 1
COMPLETED
|
24
|
29
|
|
Treatment Period 1
NOT COMPLETED
|
25
|
17
|
|
Treatment Period 2
STARTED
|
24
|
29
|
|
Treatment Period 2
COMPLETED
|
20
|
23
|
|
Treatment Period 2
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
Low-Dose Contraceptive, Then High-Dose
Females, 18-35 years old, non-pregnant, using oral contraceptive for at least the last 3 months before enrollment will be given Tri-Sprintec and generic Prometrium.
Participants in this arm will begin with the "low" dose progesterone, which is seven days of placebo Tri-sprintec + placebo generic Prometrium twice daily (7AM and 7PM). Then participants in this arm will move to the "high" dose progesterone, which is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice daily (7AM and 7PM).
|
High-Dose Contraceptive, Then Low-Dose
Females, 18-35 years old, non-pregnant, using oral contraceptive for at least the last 3 months before enrollment will be given Tri-Sprintec and generic Prometrium.
Participants in this arm will begin with the "high" progesterone dose, which is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice daily (7AM and 7PM). Then participants in this arm will move to the "low" dose progesterone, which is seven days of placebo Tri-sprintec + placebo generic Prometrium twice daily (7AM and 7PM).
|
|---|---|---|
|
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
Smoking, Sex Hormones, and Pregnancy
Baseline characteristics by cohort
| Measure |
All Participants
n=70 Participants
All participants at baseline
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
25 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hawaiian/Pacific Islander
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: after overnight abstinence on day 8Questionnaire 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.
Outcome measures
| Measure |
High-Dose Contraceptive
n=36 Participants
Females, 18-35 years old, non-pregnant, using oral contraceptive for at least the last 3 months before enrollment will be given a high-dose contraceptive.
The "high" progesterone dose is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice a day (7AM and 7PM).
|
Low-Dose Contraceptive
n=34 Participants
Females, 18-35 years old, non-pregnant, using oral contraceptive for at least the last 3 months before enrollment will be given a low-dose contraceptive.
The "low" progesterone dose is seven days of placebo Tri-sprintec + placebo generic Prometrium twice a day (7AM and 7PM).
|
|---|---|---|
|
Change in Smoking Urges
|
5.5 score on a scale
Standard Deviation 2.1
|
5.0 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: after overnight abstinence on day 8Positive 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.
Outcome measures
| Measure |
High-Dose Contraceptive
n=36 Participants
Females, 18-35 years old, non-pregnant, using oral contraceptive for at least the last 3 months before enrollment will be given a high-dose contraceptive.
The "high" progesterone dose is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice a day (7AM and 7PM).
|
Low-Dose Contraceptive
n=34 Participants
Females, 18-35 years old, non-pregnant, using oral contraceptive for at least the last 3 months before enrollment will be given a low-dose contraceptive.
The "low" progesterone dose is seven days of placebo Tri-sprintec + placebo generic Prometrium twice a day (7AM and 7PM).
|
|---|---|---|
|
Change in Positive and Negative Affect Scale Following Overnight Abstinence
Positive Affect
|
24.09 score on a scale
Interval 10.0 to 50.0
|
26.21 score on a scale
Interval 10.0 to 50.0
|
|
Change in Positive and Negative Affect Scale Following Overnight Abstinence
Negative Affect
|
15.41 score on a scale
Interval 10.0 to 37.0
|
17.01 score on a scale
Interval 10.0 to 42.0
|
SECONDARY outcome
Timeframe: after overnight abstinence on day 8Cohen 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.
Outcome measures
| Measure |
High-Dose Contraceptive
n=36 Participants
Females, 18-35 years old, non-pregnant, using oral contraceptive for at least the last 3 months before enrollment will be given a high-dose contraceptive.
The "high" progesterone dose is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice a day (7AM and 7PM).
|
Low-Dose Contraceptive
n=34 Participants
Females, 18-35 years old, non-pregnant, using oral contraceptive for at least the last 3 months before enrollment will be given a low-dose contraceptive.
The "low" progesterone dose is seven days of placebo Tri-sprintec + placebo generic Prometrium twice a day (7AM and 7PM).
|
|---|---|---|
|
Change in Cohen Perceived Stress Scale
|
15 score on a scale
Standard Deviation 3.8
|
14 score on a scale
Standard Deviation 4.3
|
Adverse Events
Low-Dose Contraceptive
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
High-Dose Contraceptive
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low-Dose Contraceptive
n=34 participants at risk
Females, 18-35 years old, non-pregnant, using oral contraceptive for at least the last 3 months before enrollment will be given a low-dose contraceptive.
The "low" progesterone dose is seven days of placebo Tri-sprintec + placebo generic Prometrium twice a day (7AM and 7PM).
|
High-Dose Contraceptive
n=36 participants at risk
Females, 18-35 years old, non-pregnant, using oral contraceptive for at least the last 3 months before enrollment will be given a high-dose contraceptive.
The "high" progesterone dose is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice a day (7AM and 7PM).
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
pain
|
5.9%
2/34 • Number of events 2 • AE were collected from oral contraceptive users over 3 months
|
0.00%
0/36 • AE were collected from oral contraceptive users over 3 months
|
|
Pregnancy, puerperium and perinatal conditions
Vomiting
|
2.9%
1/34 • Number of events 1 • AE were collected from oral contraceptive users over 3 months
|
2.8%
1/36 • Number of events 1 • AE were collected from oral contraceptive users over 3 months
|
|
Infections and infestations
Cold and Sinus infection
|
8.8%
3/34 • Number of events 3 • AE were collected from oral contraceptive users over 3 months
|
2.8%
1/36 • Number of events 1 • AE were collected from oral contraceptive users over 3 months
|
|
General disorders
Breast Tenderness or soreness
|
5.9%
2/34 • Number of events 2 • AE were collected from oral contraceptive users over 3 months
|
11.1%
4/36 • Number of events 4 • AE were collected from oral contraceptive users over 3 months
|
|
General disorders
Fatigue
|
0.00%
0/34 • AE were collected from oral contraceptive users over 3 months
|
5.6%
2/36 • Number of events 2 • AE were collected from oral contraceptive users over 3 months
|
|
General disorders
Dizzy lightheaded
|
2.9%
1/34 • Number of events 1 • AE were collected from oral contraceptive users over 3 months
|
0.00%
0/36 • AE were collected from oral contraceptive users over 3 months
|
|
General disorders
Headache
|
20.6%
7/34 • Number of events 7 • AE were collected from oral contraceptive users over 3 months
|
13.9%
5/36 • Number of events 5 • AE were collected from oral contraceptive users over 3 months
|
|
General disorders
Restless legs
|
0.00%
0/34 • AE were collected from oral contraceptive users over 3 months
|
2.8%
1/36 • Number of events 1 • AE were collected from oral contraceptive users over 3 months
|
|
General disorders
Nausea
|
0.00%
0/34 • AE were collected from oral contraceptive users over 3 months
|
5.6%
2/36 • Number of events 2 • AE were collected from oral contraceptive users over 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
5.9%
2/34 • Number of events 2 • AE were collected from oral contraceptive users over 3 months
|
0.00%
0/36 • AE were collected from oral contraceptive users over 3 months
|
|
General disorders
Vomiting
|
2.9%
1/34 • Number of events 1 • AE were collected from oral contraceptive users over 3 months
|
2.8%
1/36 • Number of events 1 • AE were collected from oral contraceptive users over 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place