Skills Based Counseling for Adherence and Depression in HIV+ Methadone Patients - 1 - Full Text View

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00218634

Purpose

Patients with HIV, depression, and opioid-dependence are at high risk for poor health outcomes. This is a two-arm randomized controlled trial of cognitive-behavioral therapy for depression and HIV medication adherence in patients with opioid dependence who are receiving methadone maintenance treatment. The project is based on our pilot work with close attention to NIDA guidelines for a staged approach to treatment development and testing (Rounsaville et al., 2001).

Depression is highly comorbid with both HIV infection and with opioid dependence. Depression and substance abuse are both associated with poor adherence to antiretroviral medications. Patients with HIV, depression, and opioid dependence are at high risk for poor health outcomes. Cognitive-behavioral therapy is the most widely studied and efficacious psychosocial intervention for depression; and research by the PI and others has shown that cognitive-behavioral interventions have been successful in promoting adherence to HIV medications.

Condition	Intervention
Adherence Behavior Therapy Depression Heroin Dependence Methadone Motivational Interviewing Substance-Related Disorders	Behavioral: Adherence

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	CBT for Depression & Adherence in HIV Methadone Patients

Resource links provided by NLM:

MedlinePlus related topics: Depression Drug Abuse HIV/AIDS Heroin

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources

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

Primary Outcome Measures:

Medication compliance

Secondary Outcome Measures:

Medication compliance
Depression
HIV viral load and CD4 count

Estimated Enrollment:	100
Study Start Date:	February 2005
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Detailed Description:

Symptoms of depression (i.e. low motivation, poor concentration, loss of interest, sad mood, suicidal ideation) that occur in the context of substance abuse or dependence can interfere with self-care behaviors necessary for maintaining HIV care, as well as interfere with potential benefit from an intervention that focuses on adherence alone. We hypothesize that teaching skills to cope with depression will improve the outcome from an adherence intervention to promote healthier living with HIV, in HIV+ opioid dependent individuals in methadone maintenance treatment.

Overview of Research Plan. Patients who are HIV positive and who are receiving methadone maintenance for opioid dependence will be randomized to treatment with either: (1) CBT, a combination of CBT for depression and HIV medication adherence, including a single session intervention for HIV medication adherence (Life-Steps, Safren et al., 2001) in conjunction with physician feedback regarding baseline study assessments or (2) the single session intervention for HIV medication adherence (Life-Steps, Safren et al., 2001) in conjunction with physician feedback regarding baseline study assessments. Participants will be followed for one-year post-randomization.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HIV seropositive
Currently enrolled in methadone maintenance treatment for at least one month
Current major or subsyndromal depression (subsyndromal depression is defined by major depression that does not meet full diagnostic criteria but with a CGI-S of 2 (mildly ill))
Is prescribed antiretroviral therapy for HIV and therefore under the care of a primary care provider.
Between the ages of 18 and 65.

Exclusion Criteria:

Active untreated, unstable, major mental illness (i.e., untreated psychosis or mania), or other Axis I psychiatric disorders (other than depression) that would interfere with the ability to participate (i.e. CGI-severity >6)
Unable or unwilling to provide informed consent.
Currently in cognitive behavioral therapy for depression.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218634

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Steven Safren, Ph.D.

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Steven Safren, MGH
ClinicalTrials.gov Identifier:	NCT00218634 History of Changes
Other Study ID Numbers:	NIDA-18603-1, R01-18603-1
Study First Received:	September 20, 2005
Last Updated:	January 7, 2010
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Depression
Depressive Disorder
Heroin Dependence
Substance-Related Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Opioid-Related Disorders
Methadone
Analgesics, Opioid
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012