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| Sponsor: | Medical University of South Carolina |
|---|---|
| Information provided by: | Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT00756925 |
Purpose
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, there are only a limited number of treatments, and no FDA approved medications for the treatment of cocaine dependence. Attempts to find reliable and successful treatments for cocaine dependence may be marred by gender differences in brain chemistry, structure, and function that are manifested as drug craving and relapse. For example, cues, drug exposure, and stress promote relapse, yet females appear be more susceptible to stress induced relapse, while males may be more susceptible to cue induced relapse. Therefore identifying the neural substrates involved in processing the valence of internal and external stimuli may provide further insight into cocaine dependence and provide more effective therapeutic strategies aimed at preventing relapse.
Corticotropin releasing hormone (CRH) is a pharmacological activator of the hypothalamic pituitary adrenal (HPA) axis, and has been implicated in stress induced drug relapse. Corticotropin releasing hormone receptors are located at extrahypothalamic brain nuclei that have been implicated in determining the significance of both internal (somatic) and external (environmental) stimuli. The primary directive of this pilot project is to utilize functional magnetic resonance imaging (fMRI) to identify possible brain nuclei associated with with stress induced drug craving in cocaine dependent females.
| Condition | Intervention |
|---|---|
|
Cocaine Dependence |
Drug: Acthrel |
| Study Type: | Observational |
| Study Design: | Case Control, Prospective |
| Official Title: | Exploring Gender Differences in the Neural Substrates of Stress Induced Drug Craving |
| Estimated Enrollment: | 20 |
| Study Start Date: | February 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Cocaine dependent females
|
Drug: Acthrel
1 ug/kg, i.v., 1 minute
|
|
2
Cocaine dependent males
|
Drug: Acthrel
1 ug/kg, i.v., 1 minute
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
A total of 20 cocaine dependent subjects (10 cocaine dependent females and 10 cocaine dependent males) will be enrolled in the study. Inclusion/exclusion criteria are listed in Section E, Human Subjects. Cocaine subjects will be matched for age and nicotine dependence. Women taking birth control pills, or Depo Provera (medroxyprogesterone acetate) will be excluded from study participation.
Subjects will be recruited through the use of flyers, advertisements on the MUSC website, MUSC broadcast messages, advertisement in local newspapers and weeklies, and similar ongoing studies within the Clinical Neuroscience Division.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Megan M Moran-Santa Maria, PhD | 843-792-8187 | moranm@musc.edu |
| United States, South Carolina | |
| Clinical Neurosciences Division-Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Megan M Moran-Santa Maria, Ph.D. | |
| Principal Investigator: Megan M Moran-Santa Maria, Ph.D. | |
More Information
| Responsible Party: | Medical University of South Carolina ( Megan Moran-Santa Maria ) |
| Study ID Numbers: | HR18441 |
| Study First Received: | September 18, 2008 |
| Last Updated: | September 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00756925 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
CRH cocaine functional magnetic resonance imaging gender differences |
|
Cocaine-Related Disorders Mental Disorders Substance-Related Disorders Disorders of Environmental Origin |