Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00228007
Recruitment Status : Completed
First Posted : September 28, 2005
Last Update Posted : August 22, 2013
National Institute of Mental Health (NIMH)
Information provided by:
Butler Hospital

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

Condition or disease Intervention/treatment Phase
Depression Substance-Related Disorders HIV Infections Drug: Antidepressant Medication Phase 3

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Maintenance of HIV risk-free drug behavior (measured at Month 12)

Secondary Outcome Measures :
  1. Reduction in depressive symptoms (measured at Month 12)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00228007

Layout table for location information
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Butler Hospital
National Institute of Mental Health (NIMH)
Layout table for investigator information
Principal Investigator: Michael Stein, MD Rhode Island Hospital
Study Director: Penelope Dennehy, MD Rhode Island Hospital

Layout table for additonal information
Responsible Party: Michael Stein, M.D./Principal Investigator, RI Hospital Identifier: NCT00228007     History of Changes
Other Study ID Numbers: R01MH062719 ( U.S. NIH Grant/Contract )
R01MH062719 ( U.S. NIH Grant/Contract )
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:
Layout table for MeSH terms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs