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Preventing Depression in Methadone Maintenance Patients Receiving Hepatitis C Treatment - 1
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), September 2005
First Received: September 20, 2005   Last Updated: November 3, 2005   History of Changes
Sponsors and Collaborators: National Institute on Drug Abuse (NIDA)
Rhode Island Hospital
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00218556
  Purpose

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.


Condition Intervention
Depressive Disorder, Major
Hepatitis C
Behavioral: Depressive Disorder, Major

Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Preventing Depression in MMT Patients on Interferon

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • depression-related antiviral treatment failure

Estimated Enrollment: 80
Study Start Date: January 2004
Estimated Study Completion Date: June 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00218556

Locations
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Susan E Ramsey, Ph.D.     401-444-7831     sramsey@lifespan.org    
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Principal Investigator: Susan E Ramsey, Ph.D. Rhode Island Hospital
  More Information

No publications provided

Study ID Numbers: NIDA-16797-1, R01-16797-1
Study First Received: September 20, 2005
Last Updated: November 3, 2005
ClinicalTrials.gov Identifier: NCT00218556     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Liver Diseases
Depression
Interferons
Hepatitis, Viral, Human
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms
Hepatitis
Virus Diseases
Methadone
Digestive System Diseases
Mental Disorders
Mood Disorders
Hepatitis C

Additional relevant MeSH terms:
RNA Virus Infections
Liver Diseases
Depression
Flaviviridae Infections
Hepatitis, Viral, Human
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms
Hepatitis
Virus Diseases
Digestive System Diseases
Mental Disorders
Mood Disorders
Hepatitis C

ClinicalTrials.gov processed this record on September 01, 2009