The main goals of these pilot studies are to obtain pharmacokinetic data for progesterone treatment in female nicotine and cocaine users and to investigate the safety and tolerability of progesterone treatment in conjunction with cocaine administration. The first study will be an open trial in which six female smokers who are in the early follicular phase of their menstrual cycle will be enrolled. Subjects will be given a single mg dose of micronized progesterone and multiple blood samples will be obtained to measure the plasma levels of progesterone. For the second study, cocaine dependent women who are in the early follicular phase of their menstrual cycle will have 2 experimental sessions. Subjects will be administered a single dose of micronized progesterone (200 mg), or placebo on each of two experimental sessions. Starting 2.5 hours after progesterone or placebe treatment, three doses of smoked cocaine (0.4 mg/kg) will be administered. We hypothesize that administration of 200 mg of progesterone will achieve plasma progesterone concentrations similar to those found in the luteal phase of the menstrual cycle, 3-30 ng/ml.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000400-33
Application #
6440666
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2000-12-01
Project End
2001-11-30
Budget Start
Budget End
Support Year
33
Fiscal Year
2001
Total Cost
Indirect Cost
Name
University of Minnesota Twin Cities
Department
Type
DUNS #
168559177
City
Minneapolis
State
MN
Country
United States
Zip Code
55455
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