Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00249483
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2005-11-03
Brief Title:
Venlafaxine to Reduce Cocaine Dependence in Depressed Individuals
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Placebo-Controlled Venlafaxine Treatment for Depressed Cocaine Abusers
Status:
COMPLETED
Status Verified Date:
2017-07
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:
Preliminary research has shown that venlafaxine a medication currently used for treating depression may also discourage cocaine use in depressed individuals This study will evaluate the effectiveness of venlafaxine in reducing cocaine use and alleviating depression in individuals addicted to cocaine
Detailed Description:
Individuals addicted to cocaine often experience feelings of restlessness irritability and anxiety They also often report feeling depressed when not using cocaine and they tend to resume cocaine use to alleviate symptoms of depression Venlafaxine is a medication that is currently used to treat depression and anxiety disorders Preliminary research has shown that venlafaxine reduces depression improves mood and simultaneously reduces cocaine use in cocaine addicts Further research is needed to confirm the benefits of venlafaxine for cocaine addicts The purpose of this study is to evaluate the effectiveness of venlafaxine in reducing cocaine use cocaine craving and depression in individuals who are addicted to cocaine and diagnosed with depression
This study will begin with a 1-week lead-in phase during which all participants will receive placebo medication Participants whose depression levels decrease will not continue in the treatment phase of the study but will be eligible for cocaine relapse therapy and medication if deemed necessary by the treating psychiatrist Participants who remain depressed following the lead-in phase will be randomly assigned to receive either venlafaxine or placebo for 12 weeks Participants assigned to venlafaxine will initially receive a daily dose of 375 mg After 4 days the dose will be increased to 75 mg each week thereafter the dose will be increased by another 75 mg up to a maximum of 300 mg per day dependent on side effects and positive responses Study visits will take place twice a week At each visit medication side effects and depression levels will be assessed cocaine levels will be monitored with urine tests and self-reports will be completed Blood will be drawn once per month for laboratory tests Participants will also attend a therapy session once a week and they will meet with a psychiatrist every other week for assessments Participants who show a decrease in depression during the 12 weeks of treatment will continue for an additional 12 weeks to further monitor cocaine use and depression levels
This study will begin with a 1-week lead-in phase during which all participants will receive placebo medication Participants whose depression levels decrease will not continue in the treatment phase of the study but will be eligible for cocaine relapse therapy and medication if deemed necessary by the treating psychiatrist Participants who remain depressed following the lead-in phase will be randomly assigned to receive either venlafaxine or placebo for 12 weeks Participants assigned to venlafaxine will initially receive a daily dose of 375 mg After 4 days the dose will be increased to 75 mg each week thereafter the dose will be increased by another 75 mg up to a maximum of 300 mg per day dependent on side effects and positive responses Study visits will take place twice a week At each visit medication side effects and depression levels will be assessed cocaine levels will be monitored with urine tests and self-reports will be completed Blood will be drawn once per month for laboratory tests Participants will also attend a therapy session once a week and they will meet with a psychiatrist every other week for assessments Participants who show a decrease in depression during the 12 weeks of treatment will continue for an additional 12 weeks to further monitor cocaine use and depression levels
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 |
|---|---|---|---|
| P50DA009236 | NIH | None | httpsreporternihgovquickSearchP50DA009236 |