Cognitive Behavioral Therapy Combined With Antidepressants to Reduce HIV Risk and Drug Relapse Among Depressed Intravenous Drug Users
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This study will evaluate the effectiveness of combining cognitive behavioral therapy (CBT) and antidepressants in reducing HIV risk behavior and drug relapse rates in depressed intravenous drug users.
Condition | Intervention | Phase |
---|---|---|
HIV Infections Depression Substance-Related Disorders |
Behavioral: Cognitive Behavioral Therapy Behavioral: Psychopharmacology |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Antidepressant Treatment to Reduce HIV Risk Among IDUs |
- HIV risk behavior; measured at Month 9
- Depression severity; measured at Month 9
Estimated Enrollment: | 175 |
Study Start Date: | September 1999 |
Study Completion Date: | February 2003 |
Depression is common among injection drug users (IDUs); it is estimated that up to 50% of IDUs meet the diagnostic criteria for major depressive disorder, a severe form of depression. The combination of drug abuse and depression increases the likelihood of engaging in HIV high-risk behaviors such as unprotected sex and the use of unhygienic needles to inject drugs. Research has shown that IDUs who receive treatment for depression have lower rates of drug relapse and are less likely to engage in high-risk sexual behavior compared to IDUs who have not received treatment for depression. Combination treatment, which includes cognitive behavioral therapy (CBT) and antidepressant medication, has been shown to be the most effective treatment for depression. This study will evaluate the effectiveness of combination treatment in reducing HIV risk behaviors and drug relapse rates in cocaine or opiate addicted IDUs with a diagnosis of depression.
In this 9-month study, participants will be randomly assigned to either a combination treatment group or an assessment only group that will receive no treatment. Participants assigned to combination treatment will receive the antidepressant Celexa, and will attend 8 CBT sessions and 7 psychopharmacology sessions. Each CBT session will last about 60 minutes and each psychopharmacology session will last about 15 minutes. If a participant does not respond well to Celexa, Wellbutrin or Effexor may be taken instead. Participants in both groups will attend 4 study visits during which they will complete standardized psychological questionnaires and interviews to assess depression levels, drug use, and high-risk sexual behaviors. Blood will be drawn at baseline and Month 9 for HIV testing.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Meets DSM-IV criteria for major depression, dysthymia, substance-induced major depression, or major depression plus dysthymia
- Score of greater than 14 on the Hamilton Depression Rating Scale
- Involved in HIV risk behaviors
- Current opiate or cocaine use
- Basic proficiency in English
Exclusion Criteria:
- Current suicidal risk or ideation
- Current psychotic symptoms
- Simultaneous medical disorder that might make psychopharmacological treatment medically inadvisable
- History of bipolar disorder, schizophrenia, schizo-affective disorder, schizophreniform disorder, or paranoid disorder
- Currently taking other medications for depression
United States, Rhode Island | |
Rhode Island Hospital | |
Providence, Rhode Island, United States, 02903 |
Principal Investigator: | Michael Stein, MD | Rhode Island Hospital |
Study Director: | Penelope Dennehy, MD | Rhode Island Hospital |
Publications:
Responsible Party: | Michael Stein, M.D./Principal Investigator, RI Hospital |
ClinicalTrials.gov Identifier: | NCT00183768 History of Changes |
Other Study ID Numbers: | R01 MH61141, DAHBR AZ-M |
Study First Received: | September 14, 2005 |
Last Updated: | December 17, 2007 |
Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
Cognitive Behavioral Treatment For Depression Antidepressant Psychopharmacology HIV Risk Behavior Injection Drug Use |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Depression Depressive Disorder Substance-Related Disorders Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Behavioral Symptoms Mood Disorders Mental Disorders Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 05, 2013