- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00535002
The Effect of Yohimbine on Cocaine Cue Reactivity
SCOR on Sex and Gender Factors Affecting Women's Health
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina-GCRC
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 CTRC admission. Nicotine dependence can affect HPA function (Baron et al., 1995) therefore it would be ideal to exclude subjects with nicotine use. Because of the high comorbidity of cocaine and nicotine dependence, this would seriously compromise the feasibility of recruitment. Individuals with alcohol dependence will be excluded. However because of the high comorbidity of alcohol use and cocaine dependence, individuals with alcohol abuse will be included. Also, due to the high comorbidity of cocaine and marijuana dependence, and limited evidence that marijuana use affects HPA function, subjects with marijuana dependence will be included.
- Subjects with ADHD will be included. Because ADHD is commonly characterized by impulsivity, ADHD severity ratings will be determined and controlled for in data analysis.
- Subjects must consent to random assignment.
- Subjects must consent to outpatient admission to the CTRC and two overnight admissions to the Medical University Hospital.
Exclusion Criteria:
- Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
- Women with premenstrual dysphoric disorder as this may impact on the response to the stress test procedure (Woods et al., 1994).
- Women receiving depot medroxyprogesterone acetate as a form of birth control.
- 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 physiological/subjective responses.
- Subjects with Addison's disease, Cushing's disease or other diseases of the adrenal cortex likely to affect hormonal/neuroendocrine status.
- Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may interfere with subjective measurements.
- Subjects with current major depressive disorder or post-traumatic stress disorder as these disorders are associated with characteristic changes in stress response.
- Subjects with panic disorder, as yohimbine may precipitate panic attacks.
- Subjects receiving synthetic glucocorticoid therapy, any exogenous steroid therapy, or treatment with other agents that interfere with hormonal measurements within one month of test session.
- Subjects taking any psychotropic medications,antidepressants, opiates or opiate antagonists because these may affect test response. Subjects taking SSRI's will be included.
- Subjects with any acute illness or fever. Individuals who otherwise meet study criteria will be rescheduled for evaluation for participation.
- Subjects who are obese (BMI>35) as this may interfere with hormonal status.
- Subjects who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (except nicotine) for three days prior to the stress task procedure.
- Subjects meeting DSM-IV criteria for substance dependence (other than nicotine, alcohol, marijuana or cocaine as appropriate) within the past 60 days.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Cocaine Females, Yohimbine then Placebo
Cocaine dependent females, received yohimbine day 1 and placebo day 2
|
Participants were pre-treated with either yohimbine or placebo.
|
Other: Cocaine Females, Placebo the Yohimbine
Cocaine dependent females, received placebo day 1 and yohimbine day 2
|
Participants were pre-treated with either yohimbine or placebo.
|
Other: Cocaine Males, Yohimbine then Placebo
Cocaine dependent males, received yohimbine day 1 and placebo day 2
|
Participants were pre-treated with either yohimbine or placebo.
|
Other: Cocaine Males, Placebo thenYohimbine
Cocaine dependent males, received placebo day 1 and yohimbine day 2
|
Participants were pre-treated with either yohimbine or placebo.
|
Other: Control Females, Yohimbine then Placebo
Non-dependent females, received yohimbine day 1 and placebo day 2
|
Participants were pre-treated with either yohimbine or placebo.
|
Other: Control Females, Placebo then Yohimbine
Non-dependent females, received placebo day 1 and yohimbine day 2
|
Participants were pre-treated with either yohimbine or placebo.
|
Other: Control Males, Yohimbine then Placebo
Non-dependent males, received yohimbine day 1 and placebo day 2
|
Participants were pre-treated with either yohimbine or placebo.
|
Other: Control Males, Placebo then Yohimbine
Non-dependent males, received placebo day 1 and yohimbine day 2
|
Participants were pre-treated with either yohimbine or placebo.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cocaine Craving
Time Frame: Post cocaine cue exposure
|
Cocaine-dependent participants were pre-treated with either yohimbine or placebo provided subjective ratings of cocaine craving immediately following cocaine cue exposure. The scale used was the Within Sessions Ratings Scales (Childress AR, McLellan AT, O'Brien CP (1986) Conditioned responses in a methadone population. A comparison of laboratory, clinic, and natural settings. Journal of Substance Abuse Treatment 3:173-179.) Craving was rated on a scale of 0-10 with 0 being Not At All and 10 being Extremely. |
Post cocaine cue exposure
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Cocaine-Related Disorders
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Urological Agents
- Adrenergic alpha-Antagonists
- Mydriatics
- Adrenergic alpha-2 Receptor Antagonists
- Yohimbine
Other Study ID Numbers
- P50DA016511-1
- P50DA016511 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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