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Clinical Trials/NCT02098434
NCT02098434
Completed
Not Applicable

Implication of Ovarian Hormones in the Neural Correlates of Stress Induced Drug Craving

Medical University of South Carolina1 site in 1 country29 target enrollmentOctober 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cocaine Dependence
Sponsor
Medical University of South Carolina
Enrollment
29
Locations
1
Primary Endpoint
Blood oxygen level dependent (BOLD)signal activation in limbic brain regions
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The study is investigating the impact of progesterone and estrogen on brain areas that are involved with stress response and drug craving. The study will involve 40 women who will participate in the Montreal Imaging Stress Task (MIST) while undergoing fMRI scanning procedures. Half of the women will complete the procedures during the luteal phase of the menstrual cycle; the other half will complete procedures during the follicular phase. Subjective and physiological measures (cortisol levels) will be used to measure stress and craving response. Hypothesis 1A is that all women will exhibit increased craving, stress response, salivary cortisol and BNST and limbic nuclei activation in response to the MIST task. Hypothesis 1B is that these increased responses will be higher for women in the luteal phase than for women in the follicular phase of the menstrual cycle.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
July 2013
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Blood oxygen level dependent (BOLD)signal activation in limbic brain regions

Time Frame: Scan visit, before and after MIST (day 1)

Exposure to the MIST task will increase activation in these brain areas as measured by fMRI scanning procedures, and the increase will be more pronounced for women in the luteal rather than follicular phase of the menstrual cycle.

Secondary Outcomes

  • Stress response on 0-10 Likert scale(Scan visit, before and after MIST (day 1))
  • Subjective craving on 0-10 Likert scale(Scan visit, before and after MIST (day 1))

Study Sites (1)

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