drugset / Trial / NCT01589068

Effects of Progesterone on IV Nicotine Induced Changes on BOLD fMRI Signal, Hormones and Subjective Ratings of Stimulant Drugs

NCT01589068

Withdrawn Mclean Hospital
Non-randomizedParallel-groupDouble-blindOther

Summary

The proposed clinical studies will analyze the interactions between progesterone, nicotine, fMRI measures of patterns of brain activity, covariance with endocrine hormones, mood and cardiovascular measures. It is hypothesized that the administration of progesterone at a dose that mimics luteal phase levels in normal cycling women will diminish the positive subjective effects of nicotine, as has been consistently observed for cocaine. This novel approach could have direct implications for facilitating smoking cessation treatment in women of reproductive age

Timeline

Start
2007-01
Primary completion
2015-12-01
Completion
2015-12-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nicotine Unknown 0.0142857 mg/kg Intravenous
Comparator Nicotine Unknown 0.0214286 mg/kg Intravenous
Comparator Nicotine Unknown 0.0285714 mg/kg Intravenous
Comparator Progesterone Other / unclassified 200 mg Oral

Indications