Ovarian Hormones and Stress Induced Drug Craving

NCT02098434 | Completed DMC

• 1 other identifier: 19884
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Dependence

Outcome Measures

Primary Outcomes (1)

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

  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.

  Scan visit, before and after MIST (day 1)

Secondary Outcomes (2)

• 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)

Other Outcomes (1)

• Salivary cortisol levels

  Scan visit, before and after MIST (day 1)

Study Arms (1)

Montreal Imaging Stress Task

EXPERIMENTAL

Math task to induce stress response

Behavioral: Montreal Imaging Stress Task

Interventions

Montreal Imaging Stress Task BEHAVIORAL

Math task developed to induce a stress response in a laboratory setting

Also known as: MIST

Montreal Imaging Stress Task

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Pre-menopausal. Individuals who are no longer menstruating regularly will not be included as we are examining ovarian hormone status on stress reactivity.
• Right-handed
• Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
• Subjects must consent to remain abstinent from all drugs of abuse (except nicotine) for a three-day period immediately prior to the CTRC admission. Participants must have a negative breathalyzer, urine drug screen.
• Subjects must consent to outpatient admission to the CTRC.
• Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease including diabetes, as these conditions may affect HPA axis function.
• Subjects with any liver function test of greater than two times normal, as compromised liver function can interfere with HPA axis activity.
• Subjects with Addison's disease, Cushing's disease or other diseases of the adrenal cortex likely to affect HPA axis function.
• Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may interfere with HPA function.
• Subjects receiving synthetic glucocorticoid therapy, any exogenous steroid therapy, or treatment with other agents, that interfere with HPA axis function within one month of the time of testing.
• Subjects taking opiates, opiate antagonists, or benzodiazepines. (Subjects who have been maintained on SSRI's, anticonvulsants, or antipsychotics (for sleep only) for more than 8 weeks or longer are NOT excluded).
• Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
• Subjects with any acute illness or fever as this may affect HPA axis activity. Individuals who otherwise meet study criteria will be rescheduled for evaluation for participation.
• Subjects who are \> 30% over ideal weight or have a BMI greater than 35 will be considered for study participation based on the clinical judgment of study staff.
• Subjects who are unwilling to maintain abstinence from alcohol and other drugs of abuse (except nicotine) for three days prior to the stress task procedure.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2012
• First Posted: March 28, 2014
• Study Start: October 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: May 7, 2018

Record last verified: 2014-11

Locations

US (1)