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

What Was Tested

The trial (not phased) is built around Oxytocin.

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.

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.

It had two arms (groups): oxytocin (experimental) and placebo (placebo comparator).

Participants will be administered 40 IUs of oxytocin nasal spray at one study visit.

Participants will be administered 40 IUs of placebo nasal spray at one study visit.

The registry classes the interventions as drug.

More on the Plan

The burden of illness is disproportionately borne by female smokers, who are less responsive to cessation interventions than males.

The relationships between stress, craving, and smoking behavior are recognized as key factors underlying gender differences in nicotine dependence, but must be better understood and characterized to yield avenues for interventions addressing this critical health disparity.

If, as hypothesized, gender, sex hormones, and oxytocin administration influence the relationships between stress, craving, and smoking behavior, the findings could substantially address a key gender-related health disparity.

Such knowledge could also inform the development of gender-specific interventions to enhance female smokers' response to cessation treatments.

Who Took Part

144 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Females and males age 18 - 45 who smoke at least an average of 5 cigarettes per day for at least past 6 months. Females must be post menarche and pre-menopausal, have a regular menstrual cycle between 25 and 35 days, and, if recently pregnant, be at least three months post-delivery/breast feeding. Participants must submit a carbon monoxide sample of ≥ 5 ppm at their screening visit.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: any serious or unstable medical or psychiatric disorder that may, in the judgment of the study physician, interfere with study completion; participants must not meet criteria for ptsd; any medication (e.g., propranolol) that may interfere with psychophysiological (e.g., heart rate) monitoring.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2012-06 with completion listed for 2017-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Craving Response to Trier Social Stress Task.

It also tracked 2 secondary outcomes, for example Stress Response to Trier Social Stress Task and Cortisol Response to Trier Social Stress Task.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 144 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, all human trials.