Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322309
Status:
COMPLETED
Last Update Posted:
2017-04-20
First Post:
2006-05-03
Brief Title:
Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects
Sponsor:
Boston University
Organization:
Boston University
Study Overview
Official Title:
The Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is being done 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
Detailed Description:
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 cocaines 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 psychosocialbehavioral 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 addicts ability to manage hisher response to craving and 4 treat underlying conditions or consequences of cocaine use that may predispose toward dependence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None