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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Rhode Island Hospital
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00218556
First received: September 20, 2005
Last updated: November 3, 2005
Last verified: September 2005
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
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

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

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

ClinicalTrials.gov processed this record on April 14, 2014