The Gender-Sex Hormone Interface With Craving & Stress-Related Changes in Smoking (SCOR-III)
|ClinicalTrials.gov Identifier: NCT01576874|
Recruitment Status : Completed
First Posted : April 13, 2012
Last Update Posted : January 31, 2018
The purpose of this 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, the study will examine the impact of a single dose of oxytocin (chemical produced in the body) versus placebo (inactive substance) on stress in males and females.
This 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.
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Dependence||Drug: Oxytocin Drug: placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Gender-Sex Hormone Interface With Craving & Stress-Related Changes in Smoking|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||June 2017|
Participants will be administered 40 IUs of oxytocin nasal spray at one study visit.
40 IUs of oxytocin administered intranasally one time
Other Name: syntocinon
Placebo Comparator: placebo
Participants will be administered 40 IUs of placebo nasal spray at one study visit.
placebo administered intranasally one time
- craving to smoking cues [ Time Frame: daily up to 14 days ]
- estrogen to progesterone ratio among female smokers [ Time Frame: daily up to 14 days ]salivary hormone levels and craving in response to the CREMA picture cues will be assessed over 14 days
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01576874
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Michael Saladin, PhD||Medical University of South Carolina|
|Principal Investigator:||Kevin M Gray, MD||Medical University of South Carolina|