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Antidepressant Medication for Reducing HIV Risk Behavior in Depressed Intravenous Drug Users

Butler Hospital logo

Butler Hospital

Status and phase

Completed
Phase 3

Conditions

Substance-Related Disorders
Depression
HIV Infections

Treatments

Drug: Antidepressant Medication

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00228007
DAHBR AZ-Q
R01MH062719 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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