drugset / Trial / NCT01589068
Effects of Progesterone on IV Nicotine Induced Changes on BOLD fMRI Signal, Hormones and Subjective Ratings of Stimulant Drugs
Withdrawn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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |