drugset / Trial / NCT01576874

The Gender-Sex Hormone Interface With Craving & Stress-Related Changes in Smoking

NCT01576874 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of the overall parent study is to determine the impact of gender and hormones (estradiol, progesterone, testosterone and cortisol) on responses to stress and smoking cues presented in daily, "real-world" cue presentations compared to a final cue session in a lab. In addition, in the portion of the study that incorporates clinical trials elements and is reported here, the study will examine the impact of a single dose of oxytocin (chemical produced in the body) versus placebo (inactive substance) on reactivity to a stress procedure (Trier Social Stress Task) in smokers. The overall parent study involves a cue presentation technology known as "CREMA" (Cue Reactivity Ecologic Momentary Assessment) which delivers four daily cue presentations to you on a handheld device during your everyday routine. Additionally, the study involves daily collection of saliva samples for hormonal testing. These daily procedures will provide information about the role of cues and hormones in daily life. The clinical trial portion of the study (reported here) consists of measures collected within the laboratory.

Timeline

Start
2012-06
Primary completion
2017-05
Completion
2017-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxytocin Peptide 40 iu Intranasal

Indications