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Ovarian Hormones and Stress Induced Drug Craving

Primary Purpose

Cocaine Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Montreal Imaging Stress Task
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cocaine Dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

GGeneral Inclusion / Exclusion Criteria Inclusion Criteria

  1. Pre-menopausal. Individuals who are no longer menstruating regularly will not be included as we are examining ovarian hormone status on stress reactivity.
  2. Right-handed
  3. Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
  4. 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.
  5. Subjects must consent to outpatient admission to the CTRC.

Exclusion Criteria

  1. 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.
  2. Subjects with any liver function test of greater than two times normal, as compromised liver function can interfere with HPA axis activity.
  3. Subjects with Addison's disease, Cushing's disease or other diseases of the adrenal cortex likely to affect HPA axis function.
  4. Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may interfere with HPA function.
  5. 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.
  6. 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).
  7. Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
  8. 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.
  9. 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.
  10. 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.
  11. Persons with ferrous metal implants or pacemaker since fMRI will be used.
  12. Subjects that are claustrophobic.
  13. Males.
  14. Women taking birth control pills, or Depo Provera (medroxyprogesterone acetate).

Inclusion Criteria Cocaine-Dependent Women a. Women meeting criteria for cocaine-dependence in the previous three months (current).

Exclusion Criteria Cocaine-Dependent Women

a. Subjects meeting DSM-IV criteria for current dependence (within 2 months) on substances other than cocaine. Nicotine dependence can affect HPA function therefore it would be ideal to exclude subjects with nicotine use. Because of the comorbidity of cocaine and nicotine dependence, this would seriously compromise the feasibility of recruitment. Alcohol has also been known to affect HPA function, however to enhance recruitment efforts, individuals with alcohol dependence or abuse will be included in the study if they do not require medically supervised detoxification.

Inclusion Criteria Non-Dependent Healthy Control Women a. As above. Exclusion Criteria Non-Dependent Healthy Control Women

a. Women meeting DSM-IV criteria for past or current substance dependence (other than nicotine).

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Montreal Imaging Stress Task

Arm Description

Math task to induce stress response

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Stress response on 0-10 Likert scale
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
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.

Full Information

First Posted
October 22, 2012
Last Updated
May 2, 2018
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT02098434
Brief Title
Ovarian Hormones and Stress Induced Drug Craving
Official Title
Implication of Ovarian Hormones in the Neural Correlates of Stress Induced Drug Craving
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Montreal Imaging Stress Task
Arm Type
Experimental
Arm Description
Math task to induce stress response
Intervention Type
Behavioral
Intervention Name(s)
Montreal Imaging Stress Task
Other Intervention Name(s)
MIST
Intervention Description
Math task developed to induce a stress response in a laboratory setting
Primary Outcome Measure Information:
Title
Blood oxygen level dependent (BOLD)signal activation in limbic brain regions
Description
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.
Time Frame
Scan visit, before and after MIST (day 1)
Secondary Outcome Measure Information:
Title
Stress response on 0-10 Likert scale
Description
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.
Time Frame
Scan visit, before and after MIST (day 1)
Title
Subjective craving on 0-10 Likert scale
Description
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.
Time Frame
Scan visit, before and after MIST (day 1)
Other Pre-specified Outcome Measures:
Title
Salivary cortisol levels
Description
Salivary samples will be collected throughout scanning procedures to determine salivary cortisol levels. It is hypothesized that cortisol levels 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.
Time Frame
Scan visit, before and after MIST (day 1)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
GGeneral Inclusion / Exclusion Criteria Inclusion Criteria 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. Exclusion Criteria 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. Persons with ferrous metal implants or pacemaker since fMRI will be used. Subjects that are claustrophobic. Males. Women taking birth control pills, or Depo Provera (medroxyprogesterone acetate). Inclusion Criteria Cocaine-Dependent Women a. Women meeting criteria for cocaine-dependence in the previous three months (current). Exclusion Criteria Cocaine-Dependent Women a. Subjects meeting DSM-IV criteria for current dependence (within 2 months) on substances other than cocaine. Nicotine dependence can affect HPA function therefore it would be ideal to exclude subjects with nicotine use. Because of the comorbidity of cocaine and nicotine dependence, this would seriously compromise the feasibility of recruitment. Alcohol has also been known to affect HPA function, however to enhance recruitment efforts, individuals with alcohol dependence or abuse will be included in the study if they do not require medically supervised detoxification. Inclusion Criteria Non-Dependent Healthy Control Women a. As above. Exclusion Criteria Non-Dependent Healthy Control Women a. Women meeting DSM-IV criteria for past or current substance dependence (other than nicotine).
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

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