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Clinical Trials/NCT00228007
NCT00228007
Completed
Phase 3

Maintaining HIV Risk Reduction Among Needle Exchangers

Butler Hospital1 site in 1 country265 target enrollmentSeptember 2000

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Depression
Sponsor
Butler Hospital
Enrollment
265
Locations
1
Primary Endpoint
Maintenance of HIV risk-free drug behavior (measured at Month 12)
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

This study will evaluate the effectiveness of antidepressant medication treatment in reducing HIV risk behaviors in intravenous drug users with depression.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 2000
End Date
September 2004
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Maintenance of HIV risk-free drug behavior (measured at Month 12)

Secondary Outcomes

  • Reduction in depressive symptoms (measured at Month 12)

Study Sites (1)

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