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Sponsored by: |
Boston University |
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Information provided by: | Boston University |
ClinicalTrials.gov Identifier: | NCT00322309 |
This research study is being done to to look at the safety of the medication Mirtazapine (Remeron) in people who have cocaine dependence and depression.
Hypotheses I. Cocaine usage will be less in the mirtazapine treatment group (MG) than in the control group (CG). II. A greater increase in Clinician Global Impression (CGI) score will be observed in the MG than in the CG. Secondary Hypotheses: I. A greater decrease in Hamilton Rating Scale for Depression (HAM-D) and Hamilton Rating Scale for Anxiety (HAM-A) scores will be observed in the MG than in the CG. II. A greater decrease in HIV risk behaviors will be observed in the MG than in the CG. III. A greater improvement in sleep structure will be observed in the MG than in the CG. IV. The proportion of subjects experiencing severe adverse drug reactions that necessitate termination from the study by one of the study clinicians will not differ between the MG and CG. V. Retention will be greater in MG than in CG.
Condition | Intervention | Phase |
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Cocaine Dependence Depression |
Drug: Mirtazapine (Remeron) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | The Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects |
Estimated Enrollment: | 64 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Mirtazapine: Experimental |
Drug: Mirtazapine (Remeron)
Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg
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Cocaine dependence is a significant public health problem associated with serious medical, psychiatric, social and economic consequences. It is generally accepted that the euphoria associated with cocaine use is a result of its action on reward pathways via antagonist properties at the dopamine transporter site; cocaine also inhibits reuptake of serotonin and norepinephrine. These actions are thought to underlie cocaine's potent reinforcing properties. With prolonged use, cocaine may deplete these neurotransmitters, affect postsynaptic receptor density, and elicit an overall dysregulation of these neurotransmitter systems. These longer term consequences may account for the post-cocaine depressive symptoms often claimed by cocaine users to contribute to relapse. Treatment for cocaine dependence at the present is primarily psychosocial/behavioral. Currently there is no pharmacological agent approved for treatment of cocaine dependence in conjunction with psychosocial interventions. Several drugs currently approved for other indications are presently under consideration for treatment of cocaine dependence based on their known mechanisms and sites of action. Current approaches include strategies to (1) block the effects of cocaine, (2) substitutes for cocaine, (3) reduce craving or enhance the addict's ability to manage his/her response to craving, and (4) treat underlying conditions (or consequences of cocaine use) that may predispose toward dependence.
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Maryam Afshar, MD | 617-414-1990 | maryam.afshar@bmc.org |
United States, Massachusetts | |
Boston University | Recruiting |
Boston, Massachusetts, United States, 02118 | |
Sub-Investigator: Sarid-Segal, MD |
Principal Investigator: | Maryam Afshar, MD | Boston University |
Responsible Party: | Boston University ( Maryam Afshar, MD ) |
Study ID Numbers: | H-22530 |
Study First Received: | May 3, 2006 |
Last Updated: | March 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00322309 History of Changes |
Health Authority: | United States: Institutional Review Board |
Cocaine Substance Abuse |
Dopamine Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Psychotropic Drugs Disorders of Environmental Origin Anesthetics Mirtazapine Dopamine Mental Disorders Vasoconstrictor Agents Substance-Related Disorders Cocaine Antidepressive Agents Cocaine-Related Disorders Depression |
Central Nervous System Depressants Adrenergic alpha-Antagonists Cardiovascular Agents Depressive Disorder Anesthetics, Local Behavioral Symptoms Antidepressive Agents, Tricyclic Histamine Histamine Antagonists Histamine H1 Antagonists Histamine phosphate Adrenergic Antagonists Dopamine Agents Peripheral Nervous System Agents |
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Disorders of Environmental Origin Anesthetics Mirtazapine Mental Disorders Sensory System Agents Therapeutic Uses Vasoconstrictor Agents Substance-Related Disorders |
Cocaine Antidepressive Agents Cocaine-Related Disorders Depression Histamine Agents Central Nervous System Depressants Adrenergic alpha-Antagonists Cardiovascular Agents Pharmacologic Actions Anesthetics, Local Behavioral Symptoms Antidepressive Agents, Tricyclic Histamine Antagonists Histamine H1 Antagonists Adrenergic Antagonists |