The Gender-Sex Hormone Interface With Craving & Stress-Related Changes in Smoking (SCOR-III)
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Purpose
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 | Intervention |
|---|---|
|
Nicotine Dependence |
Drug: Oxytocin Drug: placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Gender-Sex Hormone Interface With Craving & Stress-Related Changes in Smoking |
- craving to smoking cues [ Time Frame: daily up to 14 days ] [ Designated as safety issue: No ]
- estrogen to progesterone ratio among female smokers [ Time Frame: daily up to 14 days ] [ Designated as safety issue: No ]salivary hormone levels and craving in response to the CREMA picture cues will be assessed over 14 days
| Estimated Enrollment: | 180 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | June 2017 |
| Estimated Primary Completion Date: | March 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: oxytocin
Participants will be administered 40 IUs of oxytocin nasal spray at one study visit.
|
Drug: Oxytocin
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.
|
Drug: placebo
placebo administered intranasally one time
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Females and males age 18 - 45 who smoke at least an average of 10 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
Exclusion Criteria:
- 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 use disorders 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
Contacts and Locations| Contact: Christine Horne | 843-792-5807 | |
| Contact: Ashley McCullough | 843-792-5842 |
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Christine Horne 843-792-5807 | |
| Principal Investigator: Michael Saladin, PhD | |
| Principal Investigator: Kevin M Gray, MD | |
| Principal Investigator: | Michael Saladin, PhD | Medical University of South Carolina |
| Principal Investigator: | Kevin M Gray, MD | Medical University of South Carolina |
More Information
No publications provided
| Responsible Party: | Kevin Gray, Associate Professor, Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT01576874 History of Changes |
| Other Study ID Numbers: | Pro00016931 |
| Study First Received: | April 10, 2012 |
| Last Updated: | March 26, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Medical University of South Carolina:
|
nicotine dependence hormones |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Substance-Related Disorders Mental Disorders Hormones Oxytocin Hormones, Hormone Substitutes, and Hormone Antagonists |
Physiological Effects of Drugs Pharmacologic Actions Oxytocics Reproductive Control Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013