Antidepressant Medication for Reducing HIV Risk Behavior in Depressed Intravenous Drug Users
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ClinicalTrials.gov Identifier: NCT00228007 |
Recruitment Status
:
Completed
First Posted
: September 28, 2005
Last Update Posted
: August 22, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Depression Substance-Related Disorders HIV Infections | Drug: Antidepressant Medication | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 265 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Maintaining HIV Risk Reduction Among Needle Exchangers |
Study Start Date : | September 2000 |
Actual Study Completion Date : | September 2004 |

- Maintenance of HIV risk-free drug behavior (measured at Month 12)
- Reduction in depressive symptoms (measured at Month 12)

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00228007
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: |
R01MH062719 ( U.S. NIH Grant/Contract ) DAHBR AZ-Q |
First Posted: | September 28, 2005 Key Record Dates |
Last Update Posted: | August 22, 2013 |
Last Verified: | August 2013 |
Keywords provided by Butler Hospital:
Injection Drug Use HIV Risk Behavior HIV Seronegativity |
Additional relevant MeSH terms:
HIV Infections 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 Chemically-Induced Disorders Mental Disorders Antidepressive Agents Psychotropic Drugs |