Antidepressant Medication for Reducing HIV Risk Behavior in Depressed Intravenous Drug Users
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This study will evaluate the effectiveness of antidepressant medication treatment in reducing HIV risk behaviors in intravenous drug users with depression.
Condition | Intervention | Phase |
---|---|---|
Depression Substance-Related Disorders HIV Infections |
Drug: Antidepressant Medication |
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: | Maintaining HIV Risk Reduction Among Needle Exchangers |
- Maintenance of HIV risk-free drug behavior (measured at Month 12)
- Reduction in depressive symptoms (measured at Month 12)
Estimated Enrollment: | 265 |
Study Start Date: | September 2000 |
Study Completion Date: | September 2004 |
Depression and injection drug use often come hand-in-hand. This is especially true in populations with limited access to mental health care and with a high risk of illness and HIV transmission. Depressed injection drug users in these populations usually continue their drug use for extended periods of time, thereby further promoting the spread of HIV. This cycle has created a significant public health problem. It is necessary to explore new approaches to facilitate and maintain long-term behavior changes within this population. This study will evaluate the effectiveness of treatment with antidepressant medications in reducing HIV risk behaviors in depressed intravenous drug users.
Participants in this open label study will be randomly assigned to receive either antidepressant treatment or no treatment. Participants in the treatment group will meet with a psychiatrist monthly for 12 months. Based on psychiatric evaluations and participants' medical histories, doctors will prescribe an appropriate antidepressant medication or a combination of medications. Participants in the treatment group may also receive referrals for other services if necessary. Participants assigned to receive no treatment will be contacted at Months 3 and 9 to verify their contact information; they will also receive any necessary referrals. All participants will partake in interviews at baseline and Months 6 and 12 to assess changes in HIV risk behavior and depressive symptoms.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- DSM-IV diagnosis of major depression, dysthymia, substance-induced major depression, or major depression plus dysthymia
- Score of greater than 14 on the Hamilton Rating Scale for Depression
- Current opiate or cocaine use
- History of injection equipment sharing
- English-speaking
Exclusion Criteria:
- History of injection equipment sharing within 6 months of study entry
- Currently at risk for suicide
- Currently experiencing symptoms of psychosis
- Currently taking any other psychotropic medication
- Diagnosed with bipolar disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, or paranoid disorder
- Informed that treatment with antidepressant medications is medically inadvisable
- Pregnant
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: | NCT00228007 History of Changes |
Other Study ID Numbers: | R01 MH62719, DAHBR AZ-Q |
Study First Received: | September 26, 2005 |
Last Updated: | December 17, 2007 |
Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
Injection Drug Use HIV Risk Behavior HIV Seronegativity |
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