Cocaine DependenceNCT00756925
Gender and Neural Substrates of Stress and Craving
An observational study of Cocaine Dependence, run by Medical University of South Carolina at 1 site in United States.
Trial 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, there are only a limited number of treatments, and no FDA approved medications for the treatment of cocaine dependence. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- Acthrel
- Type of treatment
- Injection or infusion
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Neurosciences Division-Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Exploring Gender Differences in the Neural Substrates of Stress Induced Drug Craving
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.
- Conditions
- Cocaine Dependence
- Being tested
- Acthrel
- Keywords
- CRH, cocaine, functional magnetic resonance imaging, gender differences
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActhrelDrug
1 ug/kg, i.v., 1 minute
| Study group | Role | What they receive |
|---|---|---|
| 1 | Cocaine dependent females Receives: Drug: Acthrel | |
| 2 | Cocaine dependent males Receives: Drug: Acthrel |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startFeb 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan Moran-Santa Maria, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756925
- Sponsor's protocol ID
- HR18441
- Status last verified
- May 2018
- First submitted
- 18 Sep 2008
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Gender Differences in the Neural Substrates of Stress Induced Drug Craving
- ClinicalTrials.gov ID
- NCT00756925
- Acronym / sponsor ID
- HR18441
- Conditions
- Cocaine Dependence
- Keywords
- CRH, cocaine, functional magnetic resonance imaging, gender differences
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 22 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: ActhrelCocaine dependent females |
| 2 | – | Drug: ActhrelCocaine dependent males |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acthrel1 ug/kg, i.v., 1 minute | Drug | 1, 2 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cocaine Dependence, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2018.