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

Completed · Not applicable · Has a placebo group

Conditions studied: Nicotine Dependence

In brief

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.

Key facts

Study ID

NCT01576874

Run by

Kevin Gray, MD

People needed

144

Starts

2012-06-01

Expected to finish

2017-06-01

Last updated by the study team

2020-07-01

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Current substance dependence other than nicotine and caffeine use, in the past month
• Use of other tobacco products
• Females must not be pregnant, breast feeding, status post hysterectomy or bilateral oophorectomy, or taking birth control or hormone replacement medication that would affect the menstrual cycle
• Males must not be status post orchiectomy

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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