Trial Outcomes & Findings for Progesterone and Brain Imaging Study (NCT NCT01954966)
NCT ID: NCT01954966
Last Updated: 2022-07-05
Results Overview
GABA concentrations (collected in the Dorsal Anterior Cingulate Cortex \[DACC\]) will be obtained using the non-invasive neuroimaging method of proton magnetic resonance spectroscopy (1H-MRS) both before and after placebo administration and smoking abstinence. In total subjects will undergo 6 1H-MRS scans. The 6 1H-MRS scans take place over a period of approximately 1-2 months. Each paradigm (placebo/progesterone) takes approximately one week, with an approximately two-week wash in between paradigms for men and an approximately 1-month wash in between paradigms for women. The subject will undergo a smoking session on Test Day #1 and Test Day #5, MRS scans are conducted on Test Day #2 (2 scans) and Test Day #5 (1 scan). Minimal data is available for the primary outcome due to substantial issues with the 7T scanner. All subsequent scans were conducted on a 3T scanner which does not have the capacity to collect data on GABA.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
81 participants
Primary outcome timeframe
Test Day #2 and Test Day #5 - 6 total scans over the period of 2-3 months.
Results posted on
2022-07-05
Participant Flow
There were 81 participants who were enrolled in the study, but N = 15 were lost to early follow-up before they could be randomized. Therefore, only N = 66 participants were randomized (N = 34 randomized to receive placebo first, N = 32 randomized to receive progesterone first).
Participant milestones
| Measure |
Placebo First, Progesterone Second
This group was randomized to receive placebo during phase 1 of the crossover trial and progesterone during phase 2 of the crossover trial.
|
Progesterone First, Placebo Second
This group was randomized to receive progesterone during phase 1 of the crossover trial and placebo during phase 2 of the crossover trial.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
32
|
|
Overall Study
Completed Week 1 of Intervention (Drug Assigned to Receive First)
|
30
|
30
|
|
Overall Study
Started Phase 2 After Washout Period (1-2 Week for Males, 1-3 Month for Females)
|
30
|
30
|
|
Overall Study
Completed Week 2 of Intervention (Drug Assigned to Receive Second)
|
24
|
28
|
|
Overall Study
COMPLETED
|
24
|
28
|
|
Overall Study
NOT COMPLETED
|
10
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
N = 1 participant was missing age information in the progesterone first, placebo second randomization group.
Baseline characteristics by cohort
| Measure |
Placebo First, Progesterone Second
n=34 Participants
This group was randomized to receive placebo during phase 1 of the crossover trial and progesterone during phase 2 of the crossover trial.
|
Progesterone First, Placebo Second
n=32 Participants
This group was randomized to receive progesterone during phase 1 of the crossover trial and placebo during phase 2 of the crossover trial.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 9.0 • n=34 Participants • N = 1 participant was missing age information in the progesterone first, placebo second randomization group.
|
37.7 years
STANDARD_DEVIATION 7.6 • n=31 Participants • N = 1 participant was missing age information in the progesterone first, placebo second randomization group.
|
36.6 years
STANDARD_DEVIATION 8.4 • n=65 Participants • N = 1 participant was missing age information in the progesterone first, placebo second randomization group.
|
|
Sex: Female, Male
Female
|
16 Participants
n=34 Participants
|
17 Participants
n=32 Participants
|
33 Participants
n=66 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=34 Participants
|
15 Participants
n=32 Participants
|
33 Participants
n=66 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=34 Participants
|
3 Participants
n=32 Participants
|
5 Participants
n=66 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=34 Participants
|
27 Participants
n=32 Participants
|
58 Participants
n=66 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=34 Participants
|
2 Participants
n=32 Participants
|
3 Participants
n=66 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=34 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=66 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=34 Participants
|
1 Participants
n=32 Participants
|
1 Participants
n=66 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=34 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=66 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=34 Participants
|
22 Participants
n=32 Participants
|
44 Participants
n=66 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=34 Participants
|
5 Participants
n=32 Participants
|
13 Participants
n=66 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=34 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=66 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=34 Participants
|
4 Participants
n=32 Participants
|
8 Participants
n=66 Participants
|
PRIMARY outcome
Timeframe: Test Day #2 and Test Day #5 - 6 total scans over the period of 2-3 months.Population: Some values were missing due to visits for these individuals scheduled after there were issues with the 7T scanner, so data could not be collected for other participants.
GABA concentrations (collected in the Dorsal Anterior Cingulate Cortex \[DACC\]) will be obtained using the non-invasive neuroimaging method of proton magnetic resonance spectroscopy (1H-MRS) both before and after placebo administration and smoking abstinence. In total subjects will undergo 6 1H-MRS scans. The 6 1H-MRS scans take place over a period of approximately 1-2 months. Each paradigm (placebo/progesterone) takes approximately one week, with an approximately two-week wash in between paradigms for men and an approximately 1-month wash in between paradigms for women. The subject will undergo a smoking session on Test Day #1 and Test Day #5, MRS scans are conducted on Test Day #2 (2 scans) and Test Day #5 (1 scan). Minimal data is available for the primary outcome due to substantial issues with the 7T scanner. All subsequent scans were conducted on a 3T scanner which does not have the capacity to collect data on GABA.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=10 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=12 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
GABA Pre and Post Progesterone Administration (Dorsal Anterior Cingulate Cortex [DACC])
Test day 5 (pre-smoking)
|
1.21 mg/dl
Standard Error 0.05
|
1.17 mg/dl
Standard Error 0.05
|
|
GABA Pre and Post Progesterone Administration (Dorsal Anterior Cingulate Cortex [DACC])
Test day 2 (baseline, pre-scan)
|
1.23 mg/dl
Standard Error 0.05
|
1.17 mg/dl
Standard Error 0.04
|
|
GABA Pre and Post Progesterone Administration (Dorsal Anterior Cingulate Cortex [DACC])
Test day 2 (post-scan)
|
1.28 mg/dl
Standard Error 0.05
|
1.24 mg/dl
Standard Error 0.04
|
PRIMARY outcome
Timeframe: Test Day #2 and Test Day #5 - 6 total scans over the period of 2-3 months.Population: Some data was not collected for participants due to issues with the 7T.
GABA concentrations (collected in the Dorsolateral Pre-Frontal Cortex \[DLPFC\]) will be obtained using the non-invasive neuroimaging method of proton magnetic resonance spectroscopy (1H-MRS) both before and after placebo administration and smoking abstinence. In total subjects will undergo 6 1H-MRS scans. The 6 1H-MRS scans take place over a period of approximately 1-2 months. Each paradigm (placebo/progesterone) takes approximately one week, with an approximately two-week wash in between paradigms for men and an approximately 1-month wash in between paradigms for women. The subject will undergo a smoking session on Test Day #1 and Test Day #5, MRS scans are conducted on Test Day #2 (2 scans) and Test Day #5 (1 scan). Minimal data is available for the primary outcome due to substantial issues with the 7T scanner. All subsequent scans were conducted on a 3T scanner which does not have the capacity to collect data on GABA.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=10 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=12 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
GABA Pre and Post Progesterone Administration (Dorsolateral Pre-Frontal Cortex [DLPFC])
Day 2- pre scan
|
1.18 mg/dl
Standard Error 0.13
|
1.20 mg/dl
Standard Error 0.11
|
|
GABA Pre and Post Progesterone Administration (Dorsolateral Pre-Frontal Cortex [DLPFC])
Day 2- post scan
|
1.05 mg/dl
Standard Error 0.13
|
0.98 mg/dl
Standard Error 0.12
|
|
GABA Pre and Post Progesterone Administration (Dorsolateral Pre-Frontal Cortex [DLPFC])
Day 5- after scan, pre smoking
|
1.06 mg/dl
Standard Error 0.11
|
1.11 mg/dl
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Day 1 (pre and post smoking session, day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)Population: Some secondary outcome data is missing because missed visits and dropouts occurred due to the number of visits required for the study. The study team attempted to limit missing data with payment at each visit for contingency management and allowing participants to continue in the study if individual visits were missed.
Withdrawal symptoms will be measured using the Nicotine Withdrawal Symptoms Checklist (NWSC). The scale ranges from a minimum of 0 to a maximum of 28, with higher scores indicating greater withdrawal (more withdrawal symptoms, higher intensity/severity of withdrawal).
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Symptoms During Nicotine Abstinence (NWSC)
Nicotine withdrawal symptoms checklist (NWSC); day 3 abstinence AM
|
7.07 score on a scale
Standard Error 0.60
|
7.62 score on a scale
Standard Error 0.60
|
|
Symptoms During Nicotine Abstinence (NWSC)
Nicotine withdrawal symptoms checklist (NWSC); day 3 abstinence PM
|
6.99 score on a scale
Standard Error 0.60
|
7.88 score on a scale
Standard Error 0.60
|
|
Symptoms During Nicotine Abstinence (NWSC)
Nicotine withdrawal symptoms checklist (NWSC); day 1 pre 1st smoking session
|
6.00 score on a scale
Standard Error 0.59
|
6.15 score on a scale
Standard Error 0.58
|
|
Symptoms During Nicotine Abstinence (NWSC)
Nicotine withdrawal symptoms checklist (NWSC); day 1 post 1st smoking session
|
4.84 score on a scale
Standard Error 0.60
|
4.48 score on a scale
Standard Error 0.59
|
|
Symptoms During Nicotine Abstinence (NWSC)
Nicotine withdrawal symptoms checklist (NWSC); day 2 pre-scan
|
5.67 score on a scale
Standard Error 0.59
|
4.92 score on a scale
Standard Error 0.59
|
|
Symptoms During Nicotine Abstinence (NWSC)
Nicotine withdrawal symptoms checklist (NWSC); day 2 post-scan
|
5.37 score on a scale
Standard Error 0.60
|
5.25 score on a scale
Standard Error 0.60
|
|
Symptoms During Nicotine Abstinence (NWSC)
Nicotine withdrawal symptoms checklist (NWSC); day 4 abstinence AM
|
7.33 score on a scale
Standard Error 0.60
|
7.66 score on a scale
Standard Error 0.60
|
|
Symptoms During Nicotine Abstinence (NWSC)
Nicotine withdrawal symptoms checklist (NWSC); day 4 abstinence PM
|
7.19 score on a scale
Standard Error 0.60
|
7.32 score on a scale
Standard Error 0.61
|
|
Symptoms During Nicotine Abstinence (NWSC)
Nicotine withdrawal symptoms checklist (NWSC); day 5 pre-smoking
|
7.01 score on a scale
Standard Error 0.60
|
7.34 score on a scale
Standard Error 0.62
|
|
Symptoms During Nicotine Abstinence (NWSC)
Nicotine withdrawal symptoms checklist (NWSC); day 5 post-smoking
|
4.60 score on a scale
Standard Error 0.60
|
4.82 score on a scale
Standard Error 0.65
|
SECONDARY outcome
Timeframe: Day 1 (pre and post smoking session, day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Craving will be assessed using the Brief Questionnaire on Smoking Urges (BQSU). It ranges from 7-70 with higher levels indicating higher levels of nicotine craving.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Brief Questionnaire on Smoking Urges (BQSU)
Day 5; after smoking
|
27.64 score on a scale
Standard Error 2.29
|
28.22 score on a scale
Standard Error 2.42
|
|
Brief Questionnaire on Smoking Urges (BQSU)
Day 1; pre-1st smoking session
|
40.89 score on a scale
Standard Error 2.23
|
41.94 score on a scale
Standard Error 2.16
|
|
Brief Questionnaire on Smoking Urges (BQSU)
Day 1; post-1st smoking session
|
30.45 score on a scale
Standard Error 2.33
|
25.77 score on a scale
Standard Error 2.22
|
|
Brief Questionnaire on Smoking Urges (BQSU)
Day 2; pre-1st scan
|
38.47 score on a scale
Standard Error 2.28
|
34.34 score on a scale
Standard Error 2.19
|
|
Brief Questionnaire on Smoking Urges (BQSU)
Day 2; post-2nd scan
|
38.81 score on a scale
Standard Error 2.31
|
37.98 score on a scale
Standard Error 2.26
|
|
Brief Questionnaire on Smoking Urges (BQSU)
Day 3; abstinence AM
|
41.91 score on a scale
Standard Error 2.28
|
41.82 score on a scale
Standard Error 2.26
|
|
Brief Questionnaire on Smoking Urges (BQSU)
Day 3; abstinence PM
|
40.84 score on a scale
Standard Error 2.28
|
42.03 score on a scale
Standard Error 2.25
|
|
Brief Questionnaire on Smoking Urges (BQSU)
Day 4; abstinence AM
|
40.90 score on a scale
Standard Error 2.30
|
40.29 score on a scale
Standard Error 2.26
|
|
Brief Questionnaire on Smoking Urges (BQSU)
Day 4; abstinence PM
|
39.23 score on a scale
Standard Error 2.28
|
37.68 score on a scale
Standard Error 2.30
|
|
Brief Questionnaire on Smoking Urges (BQSU)
Day 5; after scan, pre-smoking
|
41.95 score on a scale
Standard Error 2.26
|
42.38 score on a scale
Standard Error 2.35
|
SECONDARY outcome
Timeframe: Day 1 (pre smoking session, day 3 (PM), day 4 (PM), day 5 (pre smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Craving will also be assessed using the Tiffany Questionnaire for Smoking Urges. It ranges from 32 to 224 with higher scores indicated higher levels of smoking urges/craving.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Tiffany Questionnaire on Smoking Urges (TQSU)
Day 1; pre-1st smoking session
|
143.45 score on a scale
Standard Error 5.13
|
140.31 score on a scale
Standard Error 5.00
|
|
Tiffany Questionnaire on Smoking Urges (TQSU)
Day 4; abstinence PM
|
139.11 score on a scale
Standard Error 5.17
|
135.88 score on a scale
Standard Error 5.36
|
|
Tiffany Questionnaire on Smoking Urges (TQSU)
Day 5; after scan, pre-smoking
|
146.22 score on a scale
Standard Error 5.11
|
141.08 score on a scale
Standard Error 5.36
|
|
Tiffany Questionnaire on Smoking Urges (TQSU)
Day 3; abstinence PM
|
138.46 score on a scale
Standard Error 5.23
|
140.77 score on a scale
Standard Error 5.29
|
SECONDARY outcome
Timeframe: Day 2 (pre and post scan), Day 5 (pre smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Profile of Mood States (POMS) Subscale: Tension-Anxiety. This subscale ranges from 0-28 with higher levels indicating greater tension/anxiety.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Profile of Mood States (POMS) Subscale: Tension-Anxiety
Day 5; after scan, pre-smoking
|
4.85 score on a scale
Standard Error 0.47
|
3.70 score on a scale
Standard Error 0.50
|
|
Profile of Mood States (POMS) Subscale: Tension-Anxiety
Day 2; pre-1st scan
|
2.88 score on a scale
Standard Error 0.46
|
2.57 score on a scale
Standard Error 0.46
|
|
Profile of Mood States (POMS) Subscale: Tension-Anxiety
Day 2; post- 2nd scan
|
3.55 score on a scale
Standard Error 0.47
|
3.11 score on a scale
Standard Error 0.47
|
SECONDARY outcome
Timeframe: Day 2 (pre and post scan), Day 5 (pre smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Profile of Mood States (POMS) Subscale: Depression-Dejection. This subscale ranges from 0-60 with higher levels indicating greater depression/dejection.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Profile of Mood States (POMS) Subscale: Depression-Dejection
Day 2; pre-1st scan
|
1.09 score on a scale
Standard Error 0.34
|
0.64 score on a scale
Standard Error 0.34
|
|
Profile of Mood States (POMS) Subscale: Depression-Dejection
Day 2; post-2nd scan
|
1.30 score on a scale
Standard Error 0.35
|
0.88 score on a scale
Standard Error 0.35
|
|
Profile of Mood States (POMS) Subscale: Depression-Dejection
Day 5; after scan, pre-smoking
|
1.66 score on a scale
Standard Error 0.35
|
1.81 score on a scale
Standard Error 0.37
|
SECONDARY outcome
Timeframe: Day 2 (pre and post scan), Day 5 (pre smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Profile of Mood States (POMS) Subscale: Anger-Hostility. This scale ranges from 0 to 48 with higher levels indicating higher levels of anger/hostility.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Profile of Mood States (POMS) Subscale: Anger-Hostility
Day 2; pre-1st scan
|
0.94 score on a scale
Standard Error 0.36
|
0.83 score on a scale
Standard Error 0.36
|
|
Profile of Mood States (POMS) Subscale: Anger-Hostility
Day 2; post-2nd scan
|
1.55 score on a scale
Standard Error 0.37
|
1.41 score on a scale
Standard Error 0.37
|
|
Profile of Mood States (POMS) Subscale: Anger-Hostility
Day 5; after scan, pre-smoking
|
2.70 score on a scale
Standard Error 0.37
|
2.36 score on a scale
Standard Error 0.39
|
SECONDARY outcome
Timeframe: Day 2 (pre and post scan), Day 5 (pre smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Profile of Mood States (POMS) Subscale: Fatigue. This subscale ranges from 0 to 28 with higher scores indicating higher levels of fatigue.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Profile of Mood States (POMS) Subscale: Fatigue
Day 2; pre-1st scan
|
2.17 score on a scale
Standard Error 0.48
|
1.77 score on a scale
Standard Error 0.49
|
|
Profile of Mood States (POMS) Subscale: Fatigue
Day 2; post-2nd scan
|
2.84 score on a scale
Standard Error 0.50
|
3.63 score on a scale
Standard Error 0.49
|
|
Profile of Mood States (POMS) Subscale: Fatigue
Day 5; after scan, pre-smoking
|
3.66 score on a scale
Standard Error 0.50
|
3.10 score on a scale
Standard Error 0.53
|
SECONDARY outcome
Timeframe: Day 2 (pre and post scan), Day 5 (pre smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Profile of Mood State (POMS) Subscale: Vigor. Subscale ranges from 0 to 32, with higher levels indicating higher levels of vigor.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Profile of Mood State (POMS) Subscale: Vigor
Day 2; pre-1st scan
|
18.71 score on a scale
Standard Error 0.94
|
18.71 score on a scale
Standard Error 0.95
|
|
Profile of Mood State (POMS) Subscale: Vigor
Day 2; post-2nd scan
|
16.74 score on a scale
Standard Error 0.96
|
16.73 score on a scale
Standard Error 0.96
|
|
Profile of Mood State (POMS) Subscale: Vigor
Day 5; after scan, pre-smoking
|
16.71 score on a scale
Standard Error 0.96
|
16.39 score on a scale
Standard Error 0.98
|
SECONDARY outcome
Timeframe: Day 2 (pre and post scan), Day 5 (pre smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Profile of Mood States (POMS) Subscale: Confusion-Bewilderment. Ranges from 0 to 28 with higher levels indicating higher levels of confusion/bewilderment.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Profile of Mood States (POMS) Subscale: Confusion-Bewilderment
Day 2; pre-1st scan
|
2.47 score on a scale
Standard Error 0.35
|
2.31 score on a scale
Standard Error 0.35
|
|
Profile of Mood States (POMS) Subscale: Confusion-Bewilderment
Day 2; post-2nd scan
|
2.95 score on a scale
Standard Error 0.36
|
2.98 score on a scale
Standard Error 0.35
|
|
Profile of Mood States (POMS) Subscale: Confusion-Bewilderment
Day 5; after scan, pre-smoking
|
3.46 score on a scale
Standard Error 0.36
|
2.80 score on a scale
Standard Error 0.37
|
SECONDARY outcome
Timeframe: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Visual Analog Scale (VAS) question: Headache. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Visual Analog Scale (VAS) Question: Headache
Day 2; pre-1st scan
|
6.50 score on a scale
Standard Error 2.55
|
7.59 score on a scale
Standard Error 2.54
|
|
Visual Analog Scale (VAS) Question: Headache
Day 2; post-2nd scan
|
5.74 score on a scale
Standard Error 2.55
|
9.39 score on a scale
Standard Error 2.57
|
|
Visual Analog Scale (VAS) Question: Headache
Day 3; abstinence AM
|
9.15 score on a scale
Standard Error 2.65
|
14.71 score on a scale
Standard Error 2.65
|
|
Visual Analog Scale (VAS) Question: Headache
Day 3; abstinence PM
|
8.86 score on a scale
Standard Error 2.67
|
10.93 score on a scale
Standard Error 2.65
|
|
Visual Analog Scale (VAS) Question: Headache
Day 4; abstinence AM
|
10.88 score on a scale
Standard Error 2.65
|
7.70 score on a scale
Standard Error 2.67
|
|
Visual Analog Scale (VAS) Question: Headache
Day 4; abstinence PM
|
11.83 score on a scale
Standard Error 2.65
|
12.78 score on a scale
Standard Error 2.71
|
|
Visual Analog Scale (VAS) Question: Headache
Day 5; after scan, pre-smoking
|
9.05 score on a scale
Standard Error 2.59
|
13.36 score on a scale
Standard Error 2.71
|
|
Visual Analog Scale (VAS) Question: Headache
Day 5; after smoking
|
11.93 score on a scale
Standard Error 2.59
|
11.67 score on a scale
Standard Error 2.75
|
SECONDARY outcome
Timeframe: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Visual Analog Scale (VAS) question: Hunger. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Visual Analog Scale (VAS) Question: Hunger
Day 4; abstinence PM
|
25.57 score on a scale
Standard Error 3.85
|
29.27 score on a scale
Standard Error 3.93
|
|
Visual Analog Scale (VAS) Question: Hunger
Day 5; after scan, pre-smoking
|
28.22 score on a scale
Standard Error 3.78
|
35.22 score on a scale
Standard Error 3.93
|
|
Visual Analog Scale (VAS) Question: Hunger
Day 5; after smoking
|
28.63 score on a scale
Standard Error 3.78
|
32.61 score on a scale
Standard Error 3.99
|
|
Visual Analog Scale (VAS) Question: Hunger
Day 2; pre-1st scan
|
34.60 score on a scale
Standard Error 3.73
|
40.23 score on a scale
Standard Error 3.70
|
|
Visual Analog Scale (VAS) Question: Hunger
Day 2; post-2nd scan
|
28.63 score on a scale
Standard Error 3.75
|
22.20 score on a scale
Standard Error 3.73
|
|
Visual Analog Scale (VAS) Question: Hunger
Day 3; abstinence AM
|
24.88 score on a scale
Standard Error 3.85
|
33.40 score on a scale
Standard Error 3.85
|
|
Visual Analog Scale (VAS) Question: Hunger
Day 3; abstinence PM
|
27.72 score on a scale
Standard Error 3.87
|
31.95 score on a scale
Standard Error 3.85
|
|
Visual Analog Scale (VAS) Question: Hunger
Day 4; abstinence AM
|
27.94 score on a scale
Standard Error 3.85
|
34.64 score on a scale
Standard Error 3.88
|
SECONDARY outcome
Timeframe: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Visual Analog Scale (VAS) question: Nauseous. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Visual Analog Scale (VAS) Question: Nauseous
Day 3; abstinence AM
|
6.01 score on a scale
Standard Error 2.14
|
10.44 score on a scale
Standard Error 2.14
|
|
Visual Analog Scale (VAS) Question: Nauseous
Day 3; abstinence PM
|
8.07 score on a scale
Standard Error 2.15
|
9.85 score on a scale
Standard Error 2.14
|
|
Visual Analog Scale (VAS) Question: Nauseous
Day 4; abstinence AM
|
6.07 score on a scale
Standard Error 2.14
|
8.22 score on a scale
Standard Error 2.15
|
|
Visual Analog Scale (VAS) Question: Nauseous
Day 2; pre-1st scan
|
5.52 score on a scale
Standard Error 2.07
|
4.92 score on a scale
Standard Error 2.06
|
|
Visual Analog Scale (VAS) Question: Nauseous
Day 2; post-2nd scan
|
6.31 score on a scale
Standard Error 2.07
|
5.43 score on a scale
Standard Error 2.08
|
|
Visual Analog Scale (VAS) Question: Nauseous
Day 4; abstinence PM
|
6.60 score on a scale
Standard Error 2.18
|
10.29 score on a scale
Standard Error 2.18
|
|
Visual Analog Scale (VAS) Question: Nauseous
Day 5; after scan, pre-smoking
|
6.51 score on a scale
Standard Error 2.10
|
10.34 score on a scale
Standard Error 2.18
|
|
Visual Analog Scale (VAS) Question: Nauseous
Day 5; after smoking
|
8.00 score on a scale
Standard Error 2.10
|
11.41 score on a scale
Standard Error 2.22
|
SECONDARY outcome
Timeframe: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Visual Analog Scale (VAS) question: Heartburn. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Visual Analog Scale (VAS) Question: Heartburn.
Day 4; abstinence AM
|
7.31 score on a scale
Standard Error 1.76
|
6.50 score on a scale
Standard Error 1.78
|
|
Visual Analog Scale (VAS) Question: Heartburn.
Day 4; abstinence PM
|
5.51 score on a scale
Standard Error 1.76
|
5.56 score on a scale
Standard Error 1.80
|
|
Visual Analog Scale (VAS) Question: Heartburn.
Day 2; pre-1st scan
|
3.11 score on a scale
Standard Error 1.70
|
2.35 score on a scale
Standard Error 1.69
|
|
Visual Analog Scale (VAS) Question: Heartburn.
Day 2; post-2nd scan
|
4.30 score on a scale
Standard Error 1.70
|
4.06 score on a scale
Standard Error 1.71
|
|
Visual Analog Scale (VAS) Question: Heartburn.
Day 3; abstinence AM
|
5.46 score on a scale
Standard Error 1.76
|
3.27 score on a scale
Standard Error 1.76
|
|
Visual Analog Scale (VAS) Question: Heartburn.
Day 3; abstinence PM
|
6.00 score on a scale
Standard Error 1.78
|
4.55 score on a scale
Standard Error 1.76
|
|
Visual Analog Scale (VAS) Question: Heartburn.
Day 5; after scan, pre-smoking
|
4.33 score on a scale
Standard Error 1.73
|
5.30 score on a scale
Standard Error 1.80
|
|
Visual Analog Scale (VAS) Question: Heartburn.
Day 5; after smoking
|
4.56 score on a scale
Standard Error 1.73
|
6.37 score on a scale
Standard Error 1.83
|
SECONDARY outcome
Timeframe: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Visual Analog Scale (VAS) question: Tired. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Visual Analog Scale (VAS) Question: Tired
Day 4; abstinence PM
|
30.69 score on a scale
Standard Error 3.89
|
28.51 score on a scale
Standard Error 3.97
|
|
Visual Analog Scale (VAS) Question: Tired
Day 5; after scan, pre-smoking
|
33.94 score on a scale
Standard Error 3.82
|
32.06 score on a scale
Standard Error 3.97
|
|
Visual Analog Scale (VAS) Question: Tired
Day 2; pre-1st scan
|
24.15 score on a scale
Standard Error 3.76
|
18.62 score on a scale
Standard Error 3.74
|
|
Visual Analog Scale (VAS) Question: Tired
Day 2; post-2nd scan
|
29.67 score on a scale
Standard Error 3.76
|
40.92 score on a scale
Standard Error 3.79
|
|
Visual Analog Scale (VAS) Question: Tired
Day 5; after smoking
|
31.22 score on a scale
Standard Error 3.82
|
34.79 score on a scale
Standard Error 4.03
|
|
Visual Analog Scale (VAS) Question: Tired
Day 3; abstinence AM
|
21.64 score on a scale
Standard Error 3.89
|
27.24 score on a scale
Standard Error 3.89
|
|
Visual Analog Scale (VAS) Question: Tired
Day 3; abstinence PM
|
30.82 score on a scale
Standard Error 3.91
|
35.53 score on a scale
Standard Error 3.89
|
|
Visual Analog Scale (VAS) Question: Tired
Day 4; abstinence AM
|
31.73 score on a scale
Standard Error 3.89
|
27.99 score on a scale
Standard Error 3.92
|
SECONDARY outcome
Timeframe: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Visual Analog Scale (VAS) question: Irritable. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Visual Analog Scale (VAS) Question: Irritable
Day 2; pre-1st scan
|
7.50 score on a scale
Standard Error 3.42
|
5.71 score on a scale
Standard Error 3.40
|
|
Visual Analog Scale (VAS) Question: Irritable
Day 4; abstinence PM
|
26.50 score on a scale
Standard Error 3.54
|
30.11 score on a scale
Standard Error 3.61
|
|
Visual Analog Scale (VAS) Question: Irritable
Day 5; after scan, pre-smoking
|
23.23 score on a scale
Standard Error 3.47
|
22.96 score on a scale
Standard Error 3.61
|
|
Visual Analog Scale (VAS) Question: Irritable
Day 2; post-2nd scan
|
13.20 score on a scale
Standard Error 3.42
|
13.01 score on a scale
Standard Error 3.44
|
|
Visual Analog Scale (VAS) Question: Irritable
Day 3; abstinence AM
|
24.80 score on a scale
Standard Error 3.54
|
24.56 score on a scale
Standard Error 3.54
|
|
Visual Analog Scale (VAS) Question: Irritable
Day 3; abstinence PM
|
23.97 score on a scale
Standard Error 3.56
|
25.49 score on a scale
Standard Error 3.54
|
|
Visual Analog Scale (VAS) Question: Irritable
Day 4; abstinence AM
|
30.79 score on a scale
Standard Error 3.54
|
29.58 score on a scale
Standard Error 3.56
|
|
Visual Analog Scale (VAS) Question: Irritable
Day 5; after smoking
|
13.45 score on a scale
Standard Error 3.47
|
15.52 score on a scale
Standard Error 3.66
|
SECONDARY outcome
Timeframe: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Visual Analog Scale (VAS) question: Energetic. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Visual Analog Scale (VAS) Question: Energetic
Day 2; pre-1st scan
|
54.86 score on a scale
Standard Error 3.68
|
67.01 score on a scale
Standard Error 3.66
|
|
Visual Analog Scale (VAS) Question: Energetic
Day 2; post-2nd scan
|
55.18 score on a scale
Standard Error 3.68
|
21.03 score on a scale
Standard Error 3.69
|
|
Visual Analog Scale (VAS) Question: Energetic
Day 3; abstinence AM
|
56.14 score on a scale
Standard Error 3.77
|
58.11 score on a scale
Standard Error 3.77
|
|
Visual Analog Scale (VAS) Question: Energetic
Day 3; abstinence PM
|
56.13 score on a scale
Standard Error 3.79
|
50.12 score on a scale
Standard Error 3.77
|
|
Visual Analog Scale (VAS) Question: Energetic
Day 4; abstinence AM
|
55.62 score on a scale
Standard Error 3.77
|
54.89 score on a scale
Standard Error 3.79
|
|
Visual Analog Scale (VAS) Question: Energetic
Day 4; abstinence PM
|
53.45 score on a scale
Standard Error 3.77
|
56.77 score on a scale
Standard Error 3.83
|
|
Visual Analog Scale (VAS) Question: Energetic
Day 5; after scan, pre-smoking
|
51.47 score on a scale
Standard Error 3.72
|
56.64 score on a scale
Standard Error 3.83
|
|
Visual Analog Scale (VAS) Question: Energetic
Day 5; after smoking
|
54.79 score on a scale
Standard Error 3.72
|
54.70 score on a scale
Standard Error 3.87
|
SECONDARY outcome
Timeframe: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Visual Analog Scale (VAS) question: Relaxed. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Visual Analog Scale (VAS) Question: Relaxed
Day 2; pre-1st scan
|
72.66 score on a scale
Standard Error 3.64
|
73.87 score on a scale
Standard Error 3.64
|
|
Visual Analog Scale (VAS) Question: Relaxed
Day 2; post-2nd scan
|
67.77 score on a scale
Standard Error 3.64
|
63.65 score on a scale
Standard Error 3.67
|
|
Visual Analog Scale (VAS) Question: Relaxed
Day 3; abstinence AM
|
63.87 score on a scale
Standard Error 3.75
|
55.85 score on a scale
Standard Error 3.77
|
|
Visual Analog Scale (VAS) Question: Relaxed
Day 3; abstinence PM
|
57.69 score on a scale
Standard Error 3.77
|
54.08 score on a scale
Standard Error 3.77
|
|
Visual Analog Scale (VAS) Question: Relaxed
Day 4; abstinence AM
|
57.83 score on a scale
Standard Error 3.75
|
55.37 score on a scale
Standard Error 3.79
|
|
Visual Analog Scale (VAS) Question: Relaxed
Day 4; abstinence PM
|
63.46 score on a scale
Standard Error 3.75
|
63.45 score on a scale
Standard Error 3.84
|
|
Visual Analog Scale (VAS) Question: Relaxed
Day 5; after scan, pre-smoking
|
62.45 score on a scale
Standard Error 3.68
|
67.65 score on a scale
Standard Error 3.81
|
|
Visual Analog Scale (VAS) Question: Relaxed
Day 5; after smoking
|
67.99 score on a scale
Standard Error 3.86
|
67.55 score on a scale
Standard Error 3.68
|
SECONDARY outcome
Timeframe: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Visual Analog Scale (VAS) question: Headache. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Visual Analog Scale (VAS) Question: Talkative
Day 4; abstinence AM
|
49.67 score on a scale
Standard Error 3.84
|
50.71 score on a scale
Standard Error 3.86
|
|
Visual Analog Scale (VAS) Question: Talkative
Day 4; abstinence PM
|
50.48 score on a scale
Standard Error 3.84
|
49.27 score on a scale
Standard Error 3.90
|
|
Visual Analog Scale (VAS) Question: Talkative
Day 2; pre-1st scan
|
54.17 score on a scale
Standard Error 3.76
|
57.46 score on a scale
Standard Error 3.75
|
|
Visual Analog Scale (VAS) Question: Talkative
Day 2; post-2nd scan
|
50.61 score on a scale
Standard Error 3.76
|
51.46 score on a scale
Standard Error 3.78
|
|
Visual Analog Scale (VAS) Question: Talkative
Day 3; abstinence AM
|
51.43 score on a scale
Standard Error 3.84
|
50.34 score on a scale
Standard Error 3.84
|
|
Visual Analog Scale (VAS) Question: Talkative
Day 3; abstinence PM
|
48.14 score on a scale
Standard Error 3.86
|
47.04 score on a scale
Standard Error 3.84
|
|
Visual Analog Scale (VAS) Question: Talkative
Day 5; after scan, pre-smoking
|
52.74 score on a scale
Standard Error 3.80
|
56.19 score on a scale
Standard Error 3.90
|
|
Visual Analog Scale (VAS) Question: Talkative
Day 5; after smoking
|
54.26 score on a scale
Standard Error 3.80
|
53.12 score on a scale
Standard Error 3.93
|
SECONDARY outcome
Timeframe: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Visual Analog Scale (VAS) question: Happy. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Visual Analog Scale (VAS) Question: Happy
Day 2; pre-1st scan
|
76.62 score on a scale
Standard Error 3.39
|
79.70 score on a scale
Standard Error 3.37
|
|
Visual Analog Scale (VAS) Question: Happy
Day 2; post-2nd scan
|
70.98 score on a scale
Standard Error 3.39
|
71.34 score on a scale
Standard Error 3.40
|
|
Visual Analog Scale (VAS) Question: Happy
Day 3; abstinence AM
|
66.22 score on a scale
Standard Error 3.47
|
64.04 score on a scale
Standard Error 3.47
|
|
Visual Analog Scale (VAS) Question: Happy
Day 3; abstinence PM
|
65.10 score on a scale
Standard Error 3.49
|
61.30 score on a scale
Standard Error 3.47
|
|
Visual Analog Scale (VAS) Question: Happy
Day 4; abstinence AM
|
62.76 score on a scale
Standard Error 3.47
|
60.58 score on a scale
Standard Error 3.49
|
|
Visual Analog Scale (VAS) Question: Happy
Day 4; abstinence PM
|
61.99 score on a scale
Standard Error 3.47
|
63.95 score on a scale
Standard Error 3.52
|
|
Visual Analog Scale (VAS) Question: Happy
Day 5; after scan, pre-smoking
|
66.59 score on a scale
Standard Error 3.42
|
63.46 score on a scale
Standard Error 3.52
|
|
Visual Analog Scale (VAS) Question: Happy
Day 5; after smoking
|
70.07 score on a scale
Standard Error 3.42
|
67.87 score on a scale
Standard Error 3.56
|
SECONDARY outcome
Timeframe: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Visual Analog Scale (VAS) question: Nervous. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Visual Analog Scale (VAS) Question: Nervous
Day 2; pre-1st scan
|
13.24 score on a scale
Standard Error 2.50
|
10.26 score on a scale
Standard Error 2.49
|
|
Visual Analog Scale (VAS) Question: Nervous
Day 2; post-2nd scan
|
10.91 score on a scale
Standard Error 2.50
|
8.46 score on a scale
Standard Error 2.52
|
|
Visual Analog Scale (VAS) Question: Nervous
Day 3; abstinence AM
|
7.19 score on a scale
Standard Error 2.57
|
8.22 score on a scale
Standard Error 2.57
|
|
Visual Analog Scale (VAS) Question: Nervous
Day 3; abstinence PM
|
9.56 score on a scale
Standard Error 2.59
|
9.24 score on a scale
Standard Error 2.57
|
|
Visual Analog Scale (VAS) Question: Nervous
Day 4; abstinence AM
|
9.36 score on a scale
Standard Error 2.57
|
11.37 score on a scale
Standard Error 2.59
|
|
Visual Analog Scale (VAS) Question: Nervous
Day 4; abstinence PM
|
10.83 score on a scale
Standard Error 2.57
|
10.66 score on a scale
Standard Error 2.62
|
|
Visual Analog Scale (VAS) Question: Nervous
Day 5; after scan, pre-smoking
|
10.79 score on a scale
Standard Error 2.53
|
12.15 score on a scale
Standard Error 2.62
|
|
Visual Analog Scale (VAS) Question: Nervous
Day 5; after smoking
|
7.64 score on a scale
Standard Error 2.53
|
11.94 score on a scale
Standard Error 2.65
|
SECONDARY outcome
Timeframe: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Visual Analog Scale (VAS) question: Sad. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Visual Analog Scale (VAS) Question: Sad
Day 2; pre-1st scan
|
3.95 score on a scale
Standard Error 1.87
|
2.09 score on a scale
Standard Error 1.85
|
|
Visual Analog Scale (VAS) Question: Sad
Day 2; post-2nd scan
|
6.77 score on a scale
Standard Error 1.87
|
4.48 score on a scale
Standard Error 1.88
|
|
Visual Analog Scale (VAS) Question: Sad
Day 3; abstinence AM
|
5.67 score on a scale
Standard Error 1.93
|
10.51 score on a scale
Standard Error 1.93
|
|
Visual Analog Scale (VAS) Question: Sad
Day 3; abstinence PM
|
4.36 score on a scale
Standard Error 1.95
|
9.07 score on a scale
Standard Error 1.93
|
|
Visual Analog Scale (VAS) Question: Sad
Day 4; abstinence AM
|
8.54 score on a scale
Standard Error 1.93
|
8.47 score on a scale
Standard Error 1.95
|
|
Visual Analog Scale (VAS) Question: Sad
Day 4; abstinence PM
|
7.32 score on a scale
Standard Error 1.93
|
8.65 score on a scale
Standard Error 1.98
|
|
Visual Analog Scale (VAS) Question: Sad
Day 5; after scan, pre-smoking
|
3.87 score on a scale
Standard Error 1.89
|
12.47 score on a scale
Standard Error 1.98
|
|
Visual Analog Scale (VAS) Question: Sad
Day 5; after smoking
|
2.95 score on a scale
Standard Error 1.89
|
5.92 score on a scale
Standard Error 2.01
|
SECONDARY outcome
Timeframe: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Visual Analog Scale (VAS) question: Calm. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Visual Analog Scale (VAS) Question: Calm
Day 2; pre-1st scan
|
74.35 score on a scale
Standard Error 3.60
|
76.52 score on a scale
Standard Error 3.58
|
|
Visual Analog Scale (VAS) Question: Calm
Day 2; post-2nd scan
|
73.15 score on a scale
Standard Error 3.60
|
69.23 score on a scale
Standard Error 3.62
|
|
Visual Analog Scale (VAS) Question: Calm
Day 3; abstinence AM
|
65.65 score on a scale
Standard Error 3.71
|
61.15 score on a scale
Standard Error 3.71
|
|
Visual Analog Scale (VAS) Question: Calm
Day 3; abstinence PM
|
58.92 score on a scale
Standard Error 3.73
|
52.44 score on a scale
Standard Error 3.71
|
|
Visual Analog Scale (VAS) Question: Calm
Day 4; abstinence AM
|
60.23 score on a scale
Standard Error 3.71
|
57.97 score on a scale
Standard Error 3.73
|
|
Visual Analog Scale (VAS) Question: Calm
Day 4; abstinence PM
|
65.47 score on a scale
Standard Error 3.71
|
62.48 score on a scale
Standard Error 3.78
|
|
Visual Analog Scale (VAS) Question: Calm
Day 5; after scan, pre-smoking
|
67.60 score on a scale
Standard Error 3.78
|
61.02 score on a scale
Standard Error 3.65
|
|
Visual Analog Scale (VAS) Question: Calm
Day 5; after smoking
|
69.27 score on a scale
Standard Error 3.65
|
70.52 score on a scale
Standard Error 3.83
|
SECONDARY outcome
Timeframe: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Visual Analog Scale (VAS) question: Depressed. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Visual Analog Scale (VAS) Question: Depressed
Day 3; abstinence PM
|
4.61 score on a scale
Standard Error 1.58
|
4.58 score on a scale
Standard Error 1.57
|
|
Visual Analog Scale (VAS) Question: Depressed
Day 4; abstinence AM
|
5.51 score on a scale
Standard Error 1.57
|
5.17 score on a scale
Standard Error 1.58
|
|
Visual Analog Scale (VAS) Question: Depressed
Day 2; pre-1st scan
|
3.97 score on a scale
Standard Error 1.52
|
2.87 score on a scale
Standard Error 1.52
|
|
Visual Analog Scale (VAS) Question: Depressed
Day 2; post-2nd scan
|
4.99 score on a scale
Standard Error 1.52
|
5.55 score on a scale
Standard Error 1.53
|
|
Visual Analog Scale (VAS) Question: Depressed
Day 3; abstinence AM
|
6.43 score on a scale
Standard Error 1.57
|
6.85 score on a scale
Standard Error 1.57
|
|
Visual Analog Scale (VAS) Question: Depressed
Day 4; abstinence PM
|
5.67 score on a scale
Standard Error 1.57
|
5.73 score on a scale
Standard Error 1.60
|
|
Visual Analog Scale (VAS) Question: Depressed
Day 5; after scan, pre-smoking
|
2.64 score on a scale
Standard Error 1.54
|
5.26 score on a scale
Standard Error 1.60
|
|
Visual Analog Scale (VAS) Question: Depressed
Day 5; after smoking
|
2.53 score on a scale
Standard Error 1.54
|
4.89 score on a scale
Standard Error 1.63
|
SECONDARY outcome
Timeframe: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Visual Analog Scale (VAS) question: Drowsy. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Visual Analog Scale (VAS) Question: Drowsy
Day 2; pre-1st scan
|
16.63 score on a scale
Standard Error 3.53
|
14.29 score on a scale
Standard Error 3.51
|
|
Visual Analog Scale (VAS) Question: Drowsy
Day 2; post-2nd scan
|
24.25 score on a scale
Standard Error 3.53
|
30.17 score on a scale
Standard Error 3.55
|
|
Visual Analog Scale (VAS) Question: Drowsy
Day 3; abstinence AM
|
17.14 score on a scale
Standard Error 3.65
|
15.43 score on a scale
Standard Error 3.65
|
|
Visual Analog Scale (VAS) Question: Drowsy
Day 3; abstinence PM
|
24.71 score on a scale
Standard Error 3.67
|
24.36 score on a scale
Standard Error 3.65
|
|
Visual Analog Scale (VAS) Question: Drowsy
Day 4; abstinence AM
|
19.56 score on a scale
Standard Error 3.65
|
18.32 score on a scale
Standard Error 3.67
|
|
Visual Analog Scale (VAS) Question: Drowsy
Day 4; abstinence PM
|
19.84 score on a scale
Standard Error 3.65
|
20.50 score on a scale
Standard Error 3.72
|
|
Visual Analog Scale (VAS) Question: Drowsy
Day 5; after scan, pre-smoking
|
23.01 score on a scale
Standard Error 3.58
|
21.01 score on a scale
Standard Error 3.72
|
|
Visual Analog Scale (VAS) Question: Drowsy
Day 5; after smoking
|
20.45 score on a scale
Standard Error 3.58
|
21.45 score on a scale
Standard Error 3.78
|
SECONDARY outcome
Timeframe: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Visual Analog Scale (VAS) question: Anxious. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Visual Analog Scale (VAS) Question: Anxious
Day 5; after scan, pre-smoking
|
17.81 score on a scale
Standard Error 3.33
|
19.05 score on a scale
Standard Error 3.44
|
|
Visual Analog Scale (VAS) Question: Anxious
Day 5; after smoking
|
16.26 score on a scale
Standard Error 3.33
|
15.30 score on a scale
Standard Error 3.48
|
|
Visual Analog Scale (VAS) Question: Anxious
Day 2; pre-1st scan
|
16.69 score on a scale
Standard Error 3.30
|
15.62 score on a scale
Standard Error 3.28
|
|
Visual Analog Scale (VAS) Question: Anxious
Day 2; post-2nd scan
|
15.02 score on a scale
Standard Error 3.30
|
12.65 score on a scale
Standard Error 3.31
|
|
Visual Analog Scale (VAS) Question: Anxious
Day 3; abstinence AM
|
20.20 score on a scale
Standard Error 3.38
|
17.38 score on a scale
Standard Error 3.38
|
|
Visual Analog Scale (VAS) Question: Anxious
Day 3; abstinence PM
|
16.38 score on a scale
Standard Error 3.40
|
20.23 score on a scale
Standard Error 3.38
|
|
Visual Analog Scale (VAS) Question: Anxious
Day 4; abstinence AM
|
18.46 score on a scale
Standard Error 3.38
|
15.08 score on a scale
Standard Error 3.40
|
|
Visual Analog Scale (VAS) Question: Anxious
Day 4; abstinence PM
|
15.88 score on a scale
Standard Error 3.38
|
15.63 score on a scale
Standard Error 3.44
|
SECONDARY outcome
Timeframe: Day 1 (pre and post smoking session, day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Positive and Negative Affect Schedule (PANAS) Negative Affect Score. Ranges from 10-50 with higher scores representing higher levels of negative affect.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Positive and Negative Affect Schedule (PANAS) Negative Affect
Day 1; pre-1st smoking session
|
11.94 score on a scale
Standard Error 0.45
|
11.43 score on a scale
Standard Error 0.44
|
|
Positive and Negative Affect Schedule (PANAS) Negative Affect
Day 1; post-1st smoking session
|
10.64 score on a scale
Standard Error 0.46
|
10.57 score on a scale
Standard Error 0.45
|
|
Positive and Negative Affect Schedule (PANAS) Negative Affect
Day 3; abstinence AM
|
12.31 score on a scale
Standard Error 0.46
|
13.01 score on a scale
Standard Error 0.46
|
|
Positive and Negative Affect Schedule (PANAS) Negative Affect
Day 3; abstinence PM
|
13.07 score on a scale
Standard Error 0.45
|
12.89 score on a scale
Standard Error 0.45
|
|
Positive and Negative Affect Schedule (PANAS) Negative Affect
Day 4; abstinence AM
|
12.51 score on a scale
Standard Error 0.45
|
13.06 score on a scale
Standard Error 0.46
|
|
Positive and Negative Affect Schedule (PANAS) Negative Affect
Day 5; after scan, pre-smoking
|
12.55 score on a scale
Standard Error 0.45
|
12.18 score on a scale
Standard Error 0.47
|
|
Positive and Negative Affect Schedule (PANAS) Negative Affect
Day 5; after smoking
|
11.41 score on a scale
Standard Error 0.47
|
11.94 score on a scale
Standard Error 0.48
|
|
Positive and Negative Affect Schedule (PANAS) Negative Affect
Day 2; pre-1st scan
|
11.25 score on a scale
Standard Error 0.45
|
11.03 score on a scale
Standard Error 0.44
|
|
Positive and Negative Affect Schedule (PANAS) Negative Affect
Day 2; post-2nd scan
|
11.59 score on a scale
Standard Error 0.46
|
11.49 score on a scale
Standard Error 0.45
|
|
Positive and Negative Affect Schedule (PANAS) Negative Affect
Day 4; abstinence PM
|
12.90 score on a scale
Standard Error 0.45
|
13.16 score on a scale
Standard Error 0.46
|
SECONDARY outcome
Timeframe: Day 1 (pre and post smoking session, day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Positive and Negative Affect Schedule (PANAS) Positive Affect Score. Ranges from 10-50 with higher scores representing higher levels of positive affect.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Positive and Negative Affect Schedule (PANAS) Positive Affect
Day 3; abstinence AM
|
32.57 score on a scale
Standard Error 1.25
|
33.30 score on a scale
Standard Error 1.25
|
|
Positive and Negative Affect Schedule (PANAS) Positive Affect
Day 4; abstinence PM
|
33.25 score on a scale
Standard Error 1.25
|
32.61 score on a scale
Standard Error 1.26
|
|
Positive and Negative Affect Schedule (PANAS) Positive Affect
Day 5; after scan, pre-smoking
|
33.45 score on a scale
Standard Error 1.25
|
32.53 score on a scale
Standard Error 1.27
|
|
Positive and Negative Affect Schedule (PANAS) Positive Affect
Day 5; after smoking
|
33.10 score on a scale
Standard Error 1.25
|
33.76 score on a scale
Standard Error 1.27
|
|
Positive and Negative Affect Schedule (PANAS) Positive Affect
Day 1; pre-1st smoking session
|
37.10 score on a scale
Standard Error 1.24
|
37.23 score on a scale
Standard Error 1.23
|
|
Positive and Negative Affect Schedule (PANAS) Positive Affect
Day 1; post-1st smoking session
|
35.72 score on a scale
Standard Error 1.25
|
36.11 score on a scale
Standard Error 1.24
|
|
Positive and Negative Affect Schedule (PANAS) Positive Affect
Day 2; pre-1st scan
|
36.08 score on a scale
Standard Error 1.24
|
36.55 score on a scale
Standard Error 1.23
|
|
Positive and Negative Affect Schedule (PANAS) Positive Affect
Day 2; post-2nd scan
|
33.51 score on a scale
Standard Error 1.25
|
34.17 score on a scale
Standard Error 1.25
|
|
Positive and Negative Affect Schedule (PANAS) Positive Affect
Day 3; abstinence PM
|
32.34 score on a scale
Standard Error 1.25
|
32.81 score on a scale
Standard Error 1.25
|
|
Positive and Negative Affect Schedule (PANAS) Positive Affect
Day 4; abstinence AM
|
32.56 score on a scale
Standard Error 1.25
|
32.03 score on a scale
Standard Error 1.25
|
SECONDARY outcome
Timeframe: Day 1 (pre smoking session), Day 5 (post smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Nicotine Effects Questionnaire (NEQ) question: feels strength of nicotine. Score ranges from 0 to 100 with higher levels indicating feeling stronger effects of nicotine after smoking.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Nicotine Effects Questionnaire (NEQ) Question: Feels Strength of Nicotine
Day 1; pre-1st smoking session
|
71.45 score on a scale
Standard Error 3.55
|
71.01 score on a scale
Standard Error 3.51
|
|
Nicotine Effects Questionnaire (NEQ) Question: Feels Strength of Nicotine
Day 5; after smoking
|
74.87 score on a scale
Standard Error 3.60
|
75.25 score on a scale
Standard Error 3.79
|
SECONDARY outcome
Timeframe: Day 1 (pre smoking session), Day 5 (post smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
NEQ question: feels good effects of nicotine. Score ranges from 0 to 100 with higher levels indicating feeling more good effects of nicotine after smoking.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Nicotine Effects Questionnaire (NEQ) Question: Feels Good Effects of Nicotine
Day 5; after smoking
|
67.84 score on a scale
Standard Error 3.80
|
64.72 score on a scale
Standard Error 3.99
|
|
Nicotine Effects Questionnaire (NEQ) Question: Feels Good Effects of Nicotine
Day 1; pre-1st smoking session
|
67.72 score on a scale
Standard Error 3.75
|
67.84 score on a scale
Standard Error 3.71
|
SECONDARY outcome
Timeframe: Day 1 (pre smoking session), Day 5 (post smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Nicotine Effects Questionnaire (NEQ) question: feels bad effects of nicotine. Score ranges from 0 to 100 with higher levels indicating feeling more bad effects of nicotine after smoking.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Nicotine Effects Questionnaire (NEQ) Question: Feels Bad Effects of Nicotine
Day 1; pre-1st smoking session
|
26.25 score on a scale
Standard Error 3.91
|
25.92 score on a scale
Standard Error 3.86
|
|
Nicotine Effects Questionnaire (NEQ) Question: Feels Bad Effects of Nicotine
Day 5; after smoking
|
25.39 score on a scale
Standard Error 3.96
|
28.70 score on a scale
Standard Error 4.19
|
SECONDARY outcome
Timeframe: Day 1 (pre smoking session), Day 5 (post smoking session)Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
Nicotine Effects Questionnaire (NEQ) question: feels head rush. Score ranges from 0 to 100 with higher levels indicating feeling stronger/more intense head rush after smoking.
Outcome measures
| Measure |
Progesterone 200 mg Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
|
Progesterone 200 mg Look-alike Capsules
n=66 Participants
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.
Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
|---|---|---|
|
Nicotine Effects Questionnaire (NEQ) Question: Head Rush
Day 1; pre-1st smoking session
|
30.58 score on a scale
Standard Error 4.65
|
29.38 score on a scale
Standard Error 4.59
|
|
Nicotine Effects Questionnaire (NEQ) Question: Head Rush
Day 5; after smoking
|
40.23 score on a scale
Standard Error 4.71
|
42.48 score on a scale
Standard Error 5.01
|
Adverse Events
Progesterone 200 mg Look-alike Capsules
Serious events: 0 serious events
Other events: 54 other events
Deaths: 0 deaths
Progesterone 200 mg Capsules
Serious events: 0 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Progesterone 200 mg Look-alike Capsules
n=66 participants at risk
This arm includes all phases when participants were received placebo (phase 1/week 1 for participants randomized to receive placebo first; phase 2/week 2 for participants randomized to receive placebo second)
|
Progesterone 200 mg Capsules
n=66 participants at risk
This arm includes all phases when participants were received progesterone (phase 1/week 1 for participants randomized to receive progesterone first; phase 2/week 2 for participants randomized to receive progesterone second)
|
|---|---|---|
|
Nervous system disorders
Headache
|
24.2%
16/66 • Number of events 18 • Adverse event data was collected during the duration of the study (2-3 months from first visit in phase 1 to final visit in phase 2 of crossover design)
|
18.2%
12/66 • Number of events 13 • Adverse event data was collected during the duration of the study (2-3 months from first visit in phase 1 to final visit in phase 2 of crossover design)
|
|
Nervous system disorders
Dizziness
|
6.1%
4/66 • Number of events 4 • Adverse event data was collected during the duration of the study (2-3 months from first visit in phase 1 to final visit in phase 2 of crossover design)
|
4.5%
3/66 • Number of events 3 • Adverse event data was collected during the duration of the study (2-3 months from first visit in phase 1 to final visit in phase 2 of crossover design)
|
|
Gastrointestinal disorders
Nausea
|
10.6%
7/66 • Number of events 7 • Adverse event data was collected during the duration of the study (2-3 months from first visit in phase 1 to final visit in phase 2 of crossover design)
|
9.1%
6/66 • Number of events 6 • Adverse event data was collected during the duration of the study (2-3 months from first visit in phase 1 to final visit in phase 2 of crossover design)
|
|
Psychiatric disorders
Irritability
|
45.5%
30/66 • Number of events 39 • Adverse event data was collected during the duration of the study (2-3 months from first visit in phase 1 to final visit in phase 2 of crossover design)
|
40.9%
27/66 • Number of events 37 • Adverse event data was collected during the duration of the study (2-3 months from first visit in phase 1 to final visit in phase 2 of crossover design)
|
|
Psychiatric disorders
Insomnia
|
12.1%
8/66 • Number of events 10 • Adverse event data was collected during the duration of the study (2-3 months from first visit in phase 1 to final visit in phase 2 of crossover design)
|
4.5%
3/66 • Number of events 3 • Adverse event data was collected during the duration of the study (2-3 months from first visit in phase 1 to final visit in phase 2 of crossover design)
|
|
Psychiatric disorders
Hypersomnia
|
4.5%
3/66 • Number of events 3 • Adverse event data was collected during the duration of the study (2-3 months from first visit in phase 1 to final visit in phase 2 of crossover design)
|
7.6%
5/66 • Number of events 9 • Adverse event data was collected during the duration of the study (2-3 months from first visit in phase 1 to final visit in phase 2 of crossover design)
|
|
Nervous system disorders
Lightheadedness
|
3.0%
2/66 • Number of events 2 • Adverse event data was collected during the duration of the study (2-3 months from first visit in phase 1 to final visit in phase 2 of crossover design)
|
1.5%
1/66 • Number of events 1 • Adverse event data was collected during the duration of the study (2-3 months from first visit in phase 1 to final visit in phase 2 of crossover design)
|
|
General disorders
Other adverse event
|
71.2%
47/66 • Number of events 117 • Adverse event data was collected during the duration of the study (2-3 months from first visit in phase 1 to final visit in phase 2 of crossover design)
|
71.2%
47/66 • Number of events 107 • Adverse event data was collected during the duration of the study (2-3 months from first visit in phase 1 to final visit in phase 2 of crossover design)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place