Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00218556
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-09-20
Brief Title:
Preventing Depression in Methadone Maintenance Patients Receiving Hepatitis C Treatment - 1
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Preventing Depression in MMT Patients on Interferon
Status:
COMPLETED
Status Verified Date:
2015-10
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:
The purpose of this study is develop and test a cognitive-behavioral intervention to prevent depression in methadone maintenance patients receiving medical treatment for hepatitis C
Detailed Description:
The purpose of this study is to develop a CBT-D intervention tailored to meet the needs of MMT patients undergoing antiviral treatment for hepatitis C In the first phase of this project Year 1 we will develop and pilot the intervention with 20 patients In the second phase of the project Years 2 and 3 we will conduct a preliminary randomized trial with 60 MMT patients to examine the efficacy of the CBT-D intervention relative to standard care condition SC
We expect that relative to the SC condition participants randomized to the CBT-D condition will have decreased likelihood of depression-related antiviral treatment failure will report lower levels of depressive symptoms will complete more IFN injections will have lower HCV RNA levels and will have fewer illicit drug use days If the efficacy of this intervention can be established in this trial and in subsequent clinical trials MMT patients who elect to undergo antiviral therapy will have a valuable adjunct or alternative to the use of antidepressants to prevent depression If found to be efficacious this intervention will maximize the receipt of IFN treatment by MMT patients thereby aiding in the prevention of liver failure hepatocellular carcinoma and liver-related death among those with HCV
We expect that relative to the SC condition participants randomized to the CBT-D condition will have decreased likelihood of depression-related antiviral treatment failure will report lower levels of depressive symptoms will complete more IFN injections will have lower HCV RNA levels and will have fewer illicit drug use days If the efficacy of this intervention can be established in this trial and in subsequent clinical trials MMT patients who elect to undergo antiviral therapy will have a valuable adjunct or alternative to the use of antidepressants to prevent depression If found to be efficacious this intervention will maximize the receipt of IFN treatment by MMT patients thereby aiding in the prevention of liver failure hepatocellular carcinoma and liver-related death among those with HCV
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 |
|---|---|---|---|
| R01-16797-1 | None | None | None |