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The Gender-Sex Hormone Interface With Craving & Stress-Related Changes in Smoking (SCOR-III)

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ClinicalTrials.gov Identifier: NCT01576874
Recruitment Status : Completed
First Posted : April 13, 2012
Last Update Posted : January 31, 2018
Information provided by (Responsible Party):
Kevin Gray, Medical University of South Carolina

Brief Summary:

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
Nicotine Dependence Drug: Oxytocin Drug: placebo

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Gender-Sex Hormone Interface With Craving & Stress-Related Changes in Smoking
Study Start Date : June 2012
Primary Completion Date : May 2017
Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones Smoking
Drug Information available for: Oxytocin
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. craving to smoking cues [ Time Frame: daily up to 14 days ]

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Females and males age 18 - 45 who smoke at least an average of 5 cigarettes per day for at least past 6 months
  2. 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
  3. Participants must submit a carbon monoxide sample of ≥ 5 ppm at their screening visit

Exclusion Criteria:

  1. Any serious or unstable medical or psychiatric disorder that may, in the judgment of the study physician, interfere with study completion
  2. Participants must not meet criteria for PTSD
  3. Any medication (e.g., propranolol) that may interfere with psychophysiological (e.g., heart rate) monitoring
  4. Current substance dependence other than nicotine and caffeine use, in the past month
  5. Use of other tobacco products
  6. 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
  7. Males must not be status post orchiectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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
Sponsors and Collaborators
Kevin Gray
Principal Investigator: Michael Saladin, PhD Medical University of South Carolina
Principal Investigator: Kevin M Gray, MD Medical University of South Carolina

Responsible Party: Kevin Gray, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01576874     History of Changes
Other Study ID Numbers: Pro00016931
First Posted: April 13, 2012    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

Keywords provided by Kevin Gray, Medical University of South Carolina:
nicotine dependence

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents