Cocaine DependenceNCT00969943
Gender Differences in Response to Cues in Cocaine Dependence
An observational study of Cocaine Dependence, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether men and women respond differently to seeing items related to cocaine use or to remembering stressful events. Four groups of individuals will be recruited to participate in this study: men with cocaine dependence, women with cocaine dependence, men without cocaine… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine Dependence
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Aug 2007
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: There will be four primary sources of recruitment for cocaine dependent subjects: (1) patients referred from the Center for Drug and Alcohol Programs (CDAP) intake coordinator, (2) individuals presenting to CDAP for either inpatient or outpatient treatment, (3) individuals presenting to the Charleston Center for inpatient or outpatient treatment, (4) and individuals presenting to the Dorchester Alcohol and Drug Commission (DADC) for treatment. Control subjects will be recruited from the Charleston community
Who may be able to join
- 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 two-day period immediately prior to the GCRC admission. In cases where lab results, subject self-report, or staff observation suggests that a patient has used alcohol or drugs within two days of hospital admission, the patient will be admitted at the discretion of on-call study staff. Nicotine dependence can affect HPA function (Baron et al., 1995) therefore it would be ideal to exclude subjects with nicotine use from all four groups. Because of the high comorbidity of alcohol use and cocaine dependence, individuals with alcohol abuse or dependence will be included. Approximately equal numbers of nicotine-dependent individuals will be recruited into each of the study groups. Alcohol use for two days prior to testing will be discouraged, and nicotine use immediately prior to the testing session will be controlled.
- Subjects must consent to random assignment.
- Subjects must consent to outpatient admission at the GCRC and two overnight admissions at the Medical University Hospital.
- Subjects must consent to a one-week and one-month follow-up visit after the GCRC admission.
Who cannot join
- Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control. Because oral contraceptives may affect HPA axis function, the number of women on various types of oral contraceptives (triphasic vs static) and women on depot progesterone will be balanced between groups
- Women with premenstrual dysphoric disorder as this may impact on the response to the stress test procedure (Woods et al., 1994).
- 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 (LFTs) of greater than two times normal, as compromised liver function can interfere with HPA axis activity (Williams \& Dluhy, 1987).
- 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.
Show all 13Show fewer
- 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.
- Women who gave birth to a child within the past 6 months of initial screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
MUSC-Clinical Neurosciences Division
Charleston, South Carolina, 29425
About this study
The purpose of this study is to evaluate whether men and women respond differently to seeing items related to cocaine use or to remembering stressful events. Four groups of individuals will be recruited to participate in this study: men with cocaine dependence, women with cocaine dependence, men without cocaine dependence, and women without cocaine dependence.
Hypothesis #1: Cocaine-dependent women will demonstrate smaller increases in neuroendocrine, but greater increases in heart rate and more cocaine craving and subjective distress when exposed to stress as compared to cocaine-dependent men and non cocaine-dependent men and women.
Read more
Hypothesis #2: Cocaine-dependent men will demonstrate greater increases in neuroendocrine, but greater increases in heart rate and more cocaine craving and subjective distress when exposed to cocaine-related cues as compared to cocaine-dependent women and non cocaine-dependent men and women.
Hypothesis #3: Cocaine-dependent women will demonstrate greater increases in heart rate and more cocaine craving and subjective distress when exposed to stress inducing stimuli as compared to their own responses to a cocaine-related cue.
Hypothesis #4: The neuroendocrine response to a stress hormone (corticotropin releasing hormone; CRH) will be greater in cocaine-dependent women as compared to cocaine-dependent men.
- Conditions
- Cocaine Dependence
- Keywords
- HPA axis
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Cocaine-dependent Men | Not described | |
| Cocaine-dependent Women | Not described | |
| Control Men | Not described | |
| Control Women | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startMar 2003
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Brady, MD, PhD, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969943
- Sponsor's protocol ID
- 10598
- Status last verified
- May 2018
- First submitted
- 1 Sep 2009
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Brady KT, McRae AL, Moran-Santa Maria MM, DeSantis SM, Simpson AN, Waldrop AE, Back SE, Kreek MJ. Response to corticotropin-releasing hormone infusion in cocaine-dependent individuals. Arch Gen Psychiatry. 2009 Apr;66(4):422-30. doi: 10.1001/archgenpsychiatry.2009.9.
PubMed 19349312
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
- Gender Differences in Response to Cues in Cocaine Dependence
- ClinicalTrials.gov ID
- NCT00969943
- Acronym / sponsor ID
- 10598
- Conditions
- Cocaine Dependence
- Keywords
- HPA axis
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Mar 2003 (actual)
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 2 Sep 2009 (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.
The purpose of this study is to evaluate whether men and women respond differently to seeing items related to cocaine use or to remembering stressful events. Four groups of individuals will be recruited to participate in this study: men with cocaine dependence, women with cocaine dependence, men without cocaine dependence, and women without cocaine dependence.
Hypothesis #1: Cocaine-dependent women will demonstrate smaller increases in neuroendocrine, but greater increases in heart rate and more cocaine craving and subjective distress when exposed to stress as compared to cocaine-dependent men and non cocaine-dependent men and women.
Hypothesis #2: Cocaine-dependent men will demonstrate greater increases in neuroendocrine, but greater increases in heart rate and more cocaine craving and subjective distress when exposed to cocaine-related cues as compared to cocaine-dependent women and non cocaine-dependent men and women.
Hypothesis #3: Cocaine-dependent women will demonstrate greater increases in heart rate and more cocaine craving and subjective distress when exposed to stress inducing stimuli as compared to their own responses to a cocaine-related cue.
Hypothesis #4: The neuroendocrine response to a stress hormone (corticotropin releasing hormone; CRH) will be greater in cocaine-dependent women as compared to cocaine-dependent men.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cocaine-dependent Men | – | – |
| Cocaine-dependent Women | – | – |
| Control Men | – | – |
| Control Women | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- There will be four primary sources of recruitment for cocaine dependent subjects: (1) patients referred from the Center for Drug and Alcohol Programs (CDAP) intake coordinator, (2) individuals presenting to CDAP for either inpatient or outpatient treatment, (3) individuals presenting to the Charleston Center for inpatient or outpatient treatment, (4) and individuals presenting to the Dorchester Alcohol and Drug Commission (DADC) for treatment. Control subjects will be recruited from the Charleston community
Key inclusion criteria (5 listed)
- 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 two-day period immediately prior to the GCRC admission. In cases where lab results, subject self-report, or staff observation suggests that a patient has used alcohol or drugs within two days of hospital admission, the patient will be admitted at the discretion of on-call study staff. Nicotine dependence can affect HPA function (Baron et al., 1995) therefore it would be ideal to exclude subjects with nicotine use from all four groups. Because of the high comorbidity of alcohol use and cocaine dependence, individuals with alcohol abuse or dependence will be included. Approximately equal numbers of nicotine-dependent individuals will be recruited into each of the study groups. Alcohol use for two days prior to testing will be discouraged, and nicotine use immediately prior to the testing session will be controlled.
- Subjects must consent to random assignment.
- Subjects must consent to outpatient admission at the GCRC and two overnight admissions at the Medical University Hospital.
- Subjects must consent to a one-week and one-month follow-up visit after the GCRC admission.
Key exclusion criteria (13 listed)
- Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control. Because oral contraceptives may affect HPA axis function, the number of women on various types of oral contraceptives (triphasic vs static) and women on depot progesterone will be balanced between groups
- Women with premenstrual dysphoric disorder as this may impact on the response to the stress test procedure (Woods et al., 1994).
- 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 (LFTs) of greater than two times normal, as compromised liver function can interfere with HPA axis activity (Williams \& Dluhy, 1987).
- Subjects with Addison's disease, Cushing's disease or other diseases of the adrenal cortex likely to affect 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.
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.
- Results publication: PubMed 19349312Brady KT, McRae AL, Moran-Santa Maria MM, DeSantis SM, Simpson AN, Waldrop AE, Back SE, Kreek MJ. Response to corticotropin-releasing hormone infusion in cocaine-dependent individuals. Arch Gen Psychiatry. 2009 Apr;66(4):422-30. doi: 10.1001/archgenpsychiatry.2009.9.
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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 5 inclusion and 13 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?
On the ClinicalTrials.gov record for NCT00969943, which also lists 1 linked publication.
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.