Ovarian Hormones and Stress Induced Drug Craving
Status: | Completed |
---|---|
Conditions: | Psychiatric, Pulmonary |
Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 5/9/2018 |
Start Date: | October 2010 |
End Date: | July 2013 |
Implication of Ovarian Hormones in the Neural Correlates of Stress Induced Drug Craving
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.
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.
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).
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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