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Progesterone Treatment in Female Smokers - 12

Tobacco Use Disorder Clinical Trial

Official title:
Progesterone Treatment in Female Smokers

Clinical Trial Summary

The purpose of this study is to investigate progesterone effects in female smokers

Clinical Trial Description

Limited research has been done on the effects of gender and menstrual cycle in response to drugs of abuse in humans. The main goal of this pilot study is to investigate the safety and tolerability of progesterone treatment in female nicotine users. In addition, plasma progesterone levels reached with a single 200 mg dose of progesterone treatment will be measured. The study will be a double-blind placebo controlled, crossover trial in which 12 female smokers who are in the early follicular phase of their menstrual cycle will be enrolled. Druing the experimental sessions, subjects will be given a single 200 mg dose of micronized progesterone or placebo and multiple blood samples will be obtained to measure the plasma levels of progesterone. Starting 2 hours after progesterone or placebo treatment, subjects will have a self-administration period that will last around 2.5 hours. 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. ;

Study Design

Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00000295
Study type Interventional
Source National Institute on Drug Abuse (NIDA)
Contact
Status Completed
Phase Phase 2
Start date April 1999
Completion date December 2001
View Details
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