Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
National Institute on Drug Abuse (NIDA) |
---|---|
Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00218634 |
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: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | CBT for Depression & Adherence in HIV Methadone Patients |
Estimated Enrollment: | 100 |
Study Start Date: | February 2005 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
CGI-severity >6)
Contact: Pamela R Handelsman, B.A. | (617)643-2147 | phandelsman@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Pamela R Handelsman, BA 617-643-2147 phandelsman@partners.org | |
Contact: Nafisseh Soroudi, Ph.D. 617 726 7458 nsoroudi@partners.org |
Principal Investigator: | Steven Safren, Ph.D. | Massachusetts General Hospital |
Study ID Numbers: | NIDA-18603-1, R01-18603-1 |
Study First Received: | September 20, 2005 |
Last Updated: | December 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00218634 History of Changes |
Health Authority: | United States: Federal Government |
Methadone Depression Mental Disorders Heroin Dependence HIV Infections Acquired Immunodeficiency Syndrome |
Mood Disorders Substance-Related Disorders Disorders of Environmental Origin Opioid-Related Disorders Depressive Disorder Behavioral Symptoms |
Depression Mental Disorders Heroin Dependence Mood Disorders Substance-Related Disorders |
Disorders of Environmental Origin Opioid-Related Disorders Depressive Disorder Behavioral Symptoms |