Skip to main content
OpenTrials
Completed

NCT Number: NCT00218556

Preventing Depression in Methadone Maintenance Patients Receiving Hepatitis C Treatment - 1

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Currently undergoing HCV treatment at RIH
  • Enrolled in MMT for at least 6 months

Exclusion criteria

  • Current major depressive episode
  • Current suicidality
  • Currently taking antidepressant medication
  • Received HCV treatment in past

Treatment and study plan

Cognitive behavioral treatment for depression

Behavioral

Cognitive behavioral intervention to prevent depressive symptoms during treatment for hepatitis C

Primary outcomes

  1. depression-related antiviral treatment failure

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Collaborators

  • Rhode Island Hospital

Registry information

Official study title

Preventing Depression in MMT Patients on Interferon

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 22, 2005
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.