Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00249444
Status:
COMPLETED
Last Update Posted:
2017-10-25
First Post:
2005-11-03
Brief Title:
Mirtazapine for Treating Cocaine Dependent Individuals Who Also Suffer From Depression
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
A Placebo Controlled Trial of Mirtazapine for Patients With Depression and Cocaine Dependence
Status:
COMPLETED
Status Verified Date:
2017-09
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:
Many substance dependent individuals also suffer from depression Past research suggests that antidepressant medication is helpful in treating such individuals This study will determine the effectiveness of mirtazapine an antidepressant medication in treating cocaine dependent individuals who also suffer from depression This study includes free treatment for cocaine dependence that includes medication and a behavioral intervention
Detailed Description:
Cocaine abuse and depression often occur together Individuals suffering from both are usually not able to quit abusing cocaine Past research conducted on alcohol dependent individuals also suffering from depression showed that these individuals were able to successfully quit drinking with the addition of an antidepressant medication Mirtazapine is a medication currently used to treat depression This study will evaluate the efficacy of mirtazapine used in combination with behavioral therapy in treating cocaine dependent individuals who also suffer from depression
Participants in this 8-week trial will be randomly assigned to receive either mirtazapine or placebo Prior to starting medication treatment participants will undergo an initial 2-week phase consisting of psychosocial and behavioral therapy The purpose of this lead-in phase is to achieve initial reduction or abstinence in cocaine use while observing cocaine withdrawal symptoms and mood changes associated with depression During these first 2 weeks participants will attend three study visits each week at which time they will participate in motivational interviews and cognitive behavioral relapse prevention therapy During this phase participants who successfully remain abstinent from cocaine use will be rewarded with high-value monetary vouchers
Upon completing the lead-in phase participants will be randomly assigned to receive either mirtazapine or placebo Participants will attend study visits twice each week for 8 weeks Mood and drug use will be evaluated at each study visit Cognitive behavioral relapse prevention therapy will continue throughout the study In addition participants will earn low-value monetary vouchers contingent on cocaine abstinence
At the end of Week 8 participants will enter the lead-out phase At this time those participants whose mood has significantly improved will be able to continue treatment for an additional 8 weeks Participants whose mood has not shown improvement will be tapered off their assigned medication treatment and will be offered treatment with an alternative medication Following completion of the lead-out phase all participants will be referred for continuing care in the community
Participants in this 8-week trial will be randomly assigned to receive either mirtazapine or placebo Prior to starting medication treatment participants will undergo an initial 2-week phase consisting of psychosocial and behavioral therapy The purpose of this lead-in phase is to achieve initial reduction or abstinence in cocaine use while observing cocaine withdrawal symptoms and mood changes associated with depression During these first 2 weeks participants will attend three study visits each week at which time they will participate in motivational interviews and cognitive behavioral relapse prevention therapy During this phase participants who successfully remain abstinent from cocaine use will be rewarded with high-value monetary vouchers
Upon completing the lead-in phase participants will be randomly assigned to receive either mirtazapine or placebo Participants will attend study visits twice each week for 8 weeks Mood and drug use will be evaluated at each study visit Cognitive behavioral relapse prevention therapy will continue throughout the study In addition participants will earn low-value monetary vouchers contingent on cocaine abstinence
At the end of Week 8 participants will enter the lead-out phase At this time those participants whose mood has significantly improved will be able to continue treatment for an additional 8 weeks Participants whose mood has not shown improvement will be tapered off their assigned medication treatment and will be offered treatment with an alternative medication Following completion of the lead-out phase all participants will be referred for continuing care in the community
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DPMC | OTHER | NIDA | httpsreporternihgovquickSearchP50DA009236-13 |
| P50DA009236 | NIH | None | None |
| P50DA009236-13 | NIH | None | None |