The Gender-Sex Hormone Interface With Craving & Stress-Related Changes in Smoking
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

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.
    

Detailed description: 
      Despite considerable advances in treatment development, cigarette smoking remains the leading
      cause of preventable death in the United States, and most smokers engaged in treatment are
      unsuccessful in quitting. 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.

      In prior and ongoing SCOR studies, our research team has demonstrated gender and menstrual
      cycle/sex hormone influences on reactivity to laboratory-presented cues. Building from these
      laboratory findings, we propose taking two important next steps: (1) evaluating the
      experience of craving in the "real world" natural environment of female and male smokers, and
      (2) examining the impact of a safe and novel pharmacological intervention (oxytocin) on
      stress reactivity in female and male smokers.

      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. Therefore, the knowledge to be gained from the proposed study may yield
      significant public health benefits.
    

Intervention name(s): Oxytocin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 IUs of oxytocin administered intranasally one time; placebo administered intranasally one time
Other intervention name(s): syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nicotine dependence; hormones