Status:
COMPLETED
Gender and Neural Substrates of Stress and Craving
Lead Sponsor:
Medical University of South Carolina
Conditions:
Cocaine Dependence
Eligibility:
All Genders
18-65 years
Brief Summary
Cocaine dependence is an insidious disease underscored by a powerful proclivity to relapse despite an individual's ability to recognize the deleterious consequences of continued drug use. To date, the...
Eligibility Criteria
Inclusion
- Age 18-65
- Right-handed
- Males and females meeting criteria for cocaine dependence (DSM-IV), within the past three months (current).
- 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 GCRC admission. 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.
- Participants must have a negative breathalyzer, urine drug screen.
- Subjects must consent to outpatient admission to the GCRC
Exclusion
- 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 with current major depressive disorder or post-traumatic stress disorder as these disorders are associated with characteristic changes in HPA axis 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).
- 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 30 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 two days prior to the stress task procedure.
- Persons with ferrous metal implants or pacemaker since fMRI will be used.
- Subjects that are claustrophobic
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00756925
Start Date
February 1 2009
End Date
August 1 2010
Last Update
May 7 2018
Active Locations (1)
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1
Clinical Neurosciences Division-Medical University of South Carolina
Charleston, South Carolina, United States, 29425