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| ID | Type | Description | Link |
|---|---|---|---|
| P50DA033942-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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Data suggest that progesterone may improve smoking cessation outcomes perhaps by reducing impulsive behavior. However, the clinical literature on this topic is lacking. Therefore, in Project I we are proposing a double-blind randomized controlled trial to assess the role of exogenous progesterone on impulsivity and smoking cessation in a sample of males and females who are motivated to quit smoking.
Subjects will be stratified by sex and then randomly assigned to active progesterone (PRO) or placebo (PBO).
Telephone screening and visit invitation leads to the consent process and in-person screening including medical-psychiatric evaluation for inclusion/exclusion, then randomization and medication induction, stable medication with medication reduction and final evaluation for secondary outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo - subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling. |
|
| Progesterone | Experimental | The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). All subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Placebo - subjects will take 200 mg twice daily orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Week 4 | 7-day point prevalence abstinence from smoking defined as having no slips (i.e., a puff or more from a lit cigarette) in the seven days prior to week 4 | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Weeks 8 and 12 | 7-day point prevalence abstinence from smoking defined as having no slips (i.e., a puff or more from a lit cigarette) in the seven days prior to weeks 8 and 12 | Weeks 8 and 12 |
| Number of Participants With Prolonged Abstinence From Smoking at Weeks 4, 8 and 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon S. Allen, M.D. | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Delaware Clinical Research Unit, University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo-Males | Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling. |
| FG001 | Progesterone-Males | Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling. |
| FG002 | Placebo-Females | Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling. |
| FG003 | Progesterone-Females | Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo-Males | Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling. |
| BG001 | Progesterone-Males |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Week 4 | 7-day point prevalence abstinence from smoking defined as having no slips (i.e., a puff or more from a lit cigarette) in the seven days prior to week 4 | Posted | Count of Participants | Participants | Week 4 |
|
Adverse events were collected between enrollment and study completion (or study dropout) which ever came first; an average of 16 weeks .
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo-Males | Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Vascular disorders | Non-systematic Assessment |
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Generalizability is limited as our sample included only premenopausal women. The sample size was too small to directly compare sex differences between men and women. Participants were only followed for 12 weeks.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sharon Allen | University of Minnesota | 612-624-0446 | allen001@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 24, 2017 | Oct 8, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Progesterone | Drug | The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). All subjects will take 200 mg twice daily orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. |
|
|
| Smoking Cessation Behavioral Counseling | Other | Subjects will receive weekly smoking cessation behavioral counseling. |
|
Prolonged abstinence defined as having less than seven consecutive slips without a 24-hour period between any two slips prior to weeks 4, 8 and 12 |
| Weeks 4, 8 and 12 |
| Number of Participants With Continuous Abstinence From Smoking at Week 12 | continuous abstinence defined as having no slips at all prior to week 12 | Week 12 |
| Number of Participants With Cotinine <50 ng/mL at Weeks 4, 8 and 12 | urine cotinine <50 ng/mL at weeks 4, 8 and 12 | Weeks 4, 8 and 12 |
| Number of Participants With Breath Carbon Monoxide ≤5 Ppm at Weeks 4, 8 and 12 | breath carbon monoxide ≤5 ppm at weeks 4, 8 and 12 | Weeks 4, 8 and 12 |
| Average Number of Days to Relapse | Days to relapse defined as the number of days from quit date to the first day with a slip | Days 1 through 84 |
Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling. |
| BG002 | Placebo-Females | Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling. |
| BG003 | Progesterone-Females | Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG002 | Placebo-Females | Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling. |
| OG003 | Progesterone-Females | Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling. |
|
|
| Secondary | Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Weeks 8 and 12 | 7-day point prevalence abstinence from smoking defined as having no slips (i.e., a puff or more from a lit cigarette) in the seven days prior to weeks 8 and 12 | Posted | Count of Participants | Participants | Weeks 8 and 12 |
|
|
|
| Secondary | Number of Participants With Prolonged Abstinence From Smoking at Weeks 4, 8 and 12 | Prolonged abstinence defined as having less than seven consecutive slips without a 24-hour period between any two slips prior to weeks 4, 8 and 12 | Posted | Count of Participants | Participants | Weeks 4, 8 and 12 |
|
|
|
| Secondary | Number of Participants With Continuous Abstinence From Smoking at Week 12 | continuous abstinence defined as having no slips at all prior to week 12 | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| Secondary | Number of Participants With Cotinine <50 ng/mL at Weeks 4, 8 and 12 | urine cotinine <50 ng/mL at weeks 4, 8 and 12 | Posted | Count of Participants | Participants | Weeks 4, 8 and 12 |
|
|
|
| Secondary | Number of Participants With Breath Carbon Monoxide ≤5 Ppm at Weeks 4, 8 and 12 | breath carbon monoxide ≤5 ppm at weeks 4, 8 and 12 | Posted | Count of Participants | Participants | Weeks 4, 8 and 12 |
|
|
|
| Secondary | Average Number of Days to Relapse | Days to relapse defined as the number of days from quit date to the first day with a slip | Posted | Mean | Standard Deviation | days | Days 1 through 84 |
|
|
|
| 0 |
| 57 |
| 0 |
| 57 |
| 0 |
| 57 |
| EG001 | Progesterone-Males | Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling. | 0 | 56 | 1 | 56 | 0 | 56 |
| EG002 | Placebo-Females | Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling. | 0 | 52 | 0 | 52 | 0 | 52 |
| EG003 | Progesterone-Females | Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling. | 0 | 51 | 0 | 51 | 0 | 51 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| Week 12 |
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| Week 8 |
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| Week 12 |
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| Week 8 |
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| Week 12 |
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| Week 8 |
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| Week 12 |
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