CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 144 enrolled
Drug / intervention
Oxytocin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01576874
NCT01576874N/ACompleted

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

Kevin Gray, MD·interventional·Posted Apr 13, 2012·Updated Jul 1, 2020

In Brief

A clinical study evaluating Oxytocin and placebo for Nicotine Dependence. Completed, enrolled 144 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 13, 2012
Enrollment StartJun 1, 2012
Primary CompletionMay 1, 2017
Study CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 14.2 years ago

Interventions

Oxytocindrug

40 IUs of oxytocin administered intranasally one time

placebodrug

placebo administered intranasally one time