Progesterone and Brain Imaging Study
Từ khóa
trừu tượng
ngày
| Xác minh lần cuối: | 06/30/2020 |
| Đệ trình đầu tiên: | 11/05/2012 |
| Đăng ký ước tính đã được gửi: | 09/25/2013 |
| Đăng lần đầu: | 10/06/2013 |
| Cập nhật lần cuối được gửi: | 07/14/2020 |
| Cập nhật lần cuối đã đăng: | 07/15/2020 |
| Ngày bắt đầu nghiên cứu thực tế: | 10/31/2010 |
| Ngày hoàn thành chính ước tính: | 06/30/2021 |
| Ngày hoàn thành nghiên cứu ước tính: | 11/30/2021 |
Tình trạng hoặc bệnh tật
Can thiệp / điều trị
Drug: Progesterone 200 mg capsules
Drug: Progesterone 200 mg look-alike capsules
Giai đoạn
Nhóm cánh tay
| Cánh tay | Can thiệp / điều trị |
|---|---|
| Active Comparator: Progesterone 200 mg capsules Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. | Drug: Progesterone 200 mg capsules 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. |
| Placebo Comparator: Progesterone 200 mg look-alike capsules 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. | Drug: Progesterone 200 mg look-alike capsules 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. |
Đủ tiêu chuẩn
| Tuổi đủ điều kiện để học | 18 Years Đến 18 Years |
| Giới tính đủ điều kiện để nghiên cứu | All |
| Chấp nhận tình nguyện viên lành mạnh | Đúng |
| Tiêu chí | Inclusion Criteria: - Female and male smokers, aged 18 to 50 years; - History of smoking greater than or equal to 10 cigarettes daily for the past year, as per self-report (periods of smoking abstinence within the last year will be exclusionary at PI discretion); - Not seeking treatment at the time of the study for nicotine dependence; - Have a Fagerstrom Test for Nicotine Dependence (FTND) score of at least 3 and a Carbon Monoxide (CO) level greater than or equal to 11 ppm; - Clean urine drug screen (marijuana is permissible); - In good health as verified by medical history; - For women, not pregnant as determined by pregnancy screening, nor breast feeding. Exclusion Criteria: - History of major medical illness: including liver diseases, abnormal vaginal bleeding, suspected or known malignancy; thrombophlebitis; deep vein thrombosis; pulmonary embolus; clotting or bleeding disorders; heart disease; diabetes; history of stroke or other medical conditions that the physician investigator deems as contraindicated for the patient to be in the study; - Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent (within previous year) psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, generalized anxiety disorder, post-traumatic stress disorder and panic disorder; - Lifetime history of schizophrenia or other psychotic disorder; - Lifetime substance dependence disorder, excepting nicotine, alcohol and marijuana, as per SCID interview - Substance use disorders within the previous 2 years, excepting nicotine, as per SCID interview - Regular use of any other tobacco products than cigarettes, including smokeless tobacco and nicotine products; - Known allergy to progesterone or peanuts (vehicle for micronized progesterone). |
Kết quả
Các biện pháp kết quả chính
1. Change from Baseline in Occipital Cortex GABA Pre and Post Placebo Administration [Test Day #2 and Test Day #5 - 6 total scans over the period of 2-3 months.]
Các biện pháp kết quả thứ cấp
1. Symptoms during nicotine abstinence [Baseline, on the day of scans, at each abstinence screening visit (4 times over a 2 day period between Test Day #2 and Test Day #5).]
2. Change from Baseline in Occipital Cortex GABA Pre and Post Progesterone Administration [Test Day #2 and Test Day #5 - 6 total scans over the period of 2-3 months.]
