Ovarian Hormones and Stress Induced Drug Craving

Not Applicable

Completed

• Conditions: Cocaine Dependence
• Interventions: Behavioral: Montreal Imaging Stress Task

• Registration Number: NCT02098434
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2012-10-22
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Study First Submitted QC: 2014-03-27
• Study First Posted: 2014-03-28
• Status Verified: 2014-11
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Montreal Imaging Stress Task	Montreal Imaging Stress Task	Math task to induce stress response

Primary Outcome Measures

Name	Time	Method
Blood oxygen level dependent (BOLD)signal activation in limbic brain regions	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 Outcome Measures

Name	Time	Method
Stress response on 0-10 Likert scale	Scan visit, before and after MIST (day 1)	Participants are asked to rate stress on a 10-point Likert scale. It is hypothesized that subjective ratings will increase following the MIST task, and that the increase will be more pronounced for women in the luteal rather than follicular phase of the menstrual cycle.
Subjective craving on 0-10 Likert scale	Scan visit, before and after MIST (day 1)	Participants are asked to rate craving on a 10-point Likert scale. It is hypothesized that craving greater after completion of the MIST than before the MIST task, and that the increase will be more pronounced for women in the luteal rather than follicular phase of the menstrual cycle.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States