- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00613015
Stress and Medication Effects on Cocaine Cue Reactivity
Interdisciplinary Medication Development for Multiple Risk Factors in Relapse.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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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) during the GCRC admission.
Because of the high comorbidity of alcohol and marijuana use and cocaine dependence, individuals meeting dependence for alcohol and marijuana will be included. Individuals requiring medical detox from alcohol will be excluded.
Subjects must consent to random assignment to stress vs. no stress and drug treatment conditions.
Exclusion Criteria:
Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control. Modafinil inhibits metabolism of steroidal contraceptives via CYP3A4 and can reduce the effectiveness of this type of birth control, female subjects must use one of the following methods of birth control: barrier methods (diaphragm or condoms with spermicide or both), surgical sterilization, use of an intra-uterine contraceptive device, or complete abstinence from sexual intercourse.
Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular (including but not limited to left ventricular hypertrophy (unless a cardiologist deems that it is not clinically significant), mitral valve prolapse, left bundle branch block, myocardial infarction, and angina), 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 and Dluhy 1987) and may affect drug metabolism.
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 any psychotropic medications, opiates or opiate antagonists because these may affect HPA axis function.Participants taking SSRI's will be included.
Subjects required to take medications that could adversely interact with study medications, including, but not limited to, azole type antifungals, cyclosporine, warfarin, theophylline, or carbamazepine. Any medications that induce or inhibit CYP3A4 pathways are excluded, as modafinil is metabolized through this enzyme system.
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 grossly obese (BMI > 39), as this may interfere with HPA axis function.
Subjects who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (except nicotine) prior to the stress task procedure.
Subjects meeting DSM-IV criteria for substance dependence (other than nicotine, cocaine, alcohol or marijuana) within the past 60 days.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Modafinil/Stress
Participants received placebo for 2 days.
modafinil on the third day and participated in the TRIER social stress task on the third day.
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Experimental: Modafinil/no stress
Participants received placebo for 2 days.
modafinil on the third day and did not participate in the TRIER social stress task on the third day.
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Experimental: Guanfacine/stress
Participants received guanfacine for 3 days and participated in the TRIER social stress task on the third day.
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Experimental: Guanfacine/no stress
Participants received guanfacine for 3 days and did not participate in the TRIER social stress task on the third day.
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Placebo Comparator: Placebo/Stress
Participants received placebo for 3 days and participated in the TRIER social stress task on the third day.
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Placebo Comparator: Placebo/no stress
Participants received placebo for 3 days and did not participate in the TRIER social stress task on the third day.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cocaine Craving
Time Frame: Post Trier social stress task + Cocaine Cue 2:30 pm
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Participants were randomized to the modafinil, guanfacine, or placebo treatment group.
Participants were then randomized to participate in the TRIER social stress task or to read magazines for 15 minutes.
Following the task, participants were exposed to neutral cues for 2 minutes and cocaine cues for 2 minutes.
Immediately following the cocaine cue exposure, participants were asked to rate cocaine craving on a 10-point Likert scale, with 0 being Not at All and 10 being Extremely.
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Post Trier social stress task + Cocaine Cue 2:30 pm
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cortisol- 2:30 pm, Immediately Following Trier Social Stress Task + Cocaine Cue Exposure
Time Frame: Immediately following trier + cocaine cue exposure
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Participants were randomized to receive to the modafinil, guanfacine, or placebo treatment group.
Participants were then randomized to complete a TRIER social stress task or read magazines for 15 minutes.
Following the task, participants were exposed to neutral cues for two minutes and control cues for two minutes.
Immediately following exposure to the cocaine cue, saliva samples were collected to measure cortisol levels.
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Immediately following trier + cocaine cue exposure
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ronald E See, Ph.D., Medical University of South Carolina
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 Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Central Nervous System Stimulants
- Wakefulness-Promoting Agents
- Modafinil
- Guanfacine
Other Study ID Numbers
- R01DA021690 (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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