Smoking, Sex Hormones, and Pregnancy

Contraception Clinical Trial

Official title: Smoking, Sex Hormones, and Pregnancy

Status Completed

Clinical Trial Summary

The investigators aim to (1) examine the association between levels of progesterone (Prog), allopregnanolone (Allo), and the estradiol/progesterone (E2/P) ratios with smoking-related symptomatology during ad libitum smoking and (2) determine the association between Prog, Allo, and E2/P with the changes in smoking-related symptomatology and response to nicotine following overnight abstinence

Clinical Trial Description

The sample population will consist of oral contraceptive users, both "low" and "high" dose levels of exogenous progesterone with a consistent dose of exogenous estrogen. Participants will complete data collection procedures including providing saliva (cortisol to measure stress), urine (cotinine and 3-Hydroxycotinine to measure nicotine exposure), and blood (progesterone, allopregnanolone, and estradiol) samples, as well as ecological momentary assessments (EMA) daily for seven-days. Participants will also complete a 3-hour smoking topography lab session after overnight abstinence and a 4.5-hour nicotine nasal spray lab session after a 14-hour abstinence. These sessions will contain a nicotine challenge via smoking a cigarette or nasal spray with timed-series physiological, subjective, and behavioral responses. ;

Related Conditions & MeSH terms

• Contraception
• Nicotine Dependence
• Tobacco Use Disorder

• NCT number: NCT01811225
• Study type: Interventional
• Source: University of Minnesota
• Status: Completed
• Phase: Phase 2
• Start date: December 2012
• Completion date: June 2017