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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Medical University of South Carolina
Sponsor:
Information provided by (Responsible Party):
Kevin Gray, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01576874
First received: April 10, 2012
Last updated: March 24, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • craving to smoking cues [ Time Frame: daily up to 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576874

Contacts
Contact: Christine Horne 843-792-5807
Contact: Lori Ann Ueberroth 843-792-8220

Locations
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         
Sponsors and Collaborators
Kevin Gray
Investigators
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 24, 2014
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
Chemically-Induced 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 August 21, 2014