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

September 26, 2005
September 28, 2005
August 22, 2013
September 2000
Not Provided
Maintenance of HIV risk-free drug behavior (measured at Month 12)
Maintenance of HIV risk free drug behavior; measured at Month 12
Complete list of historical versions of study NCT00228007 on Archive Site
Reduction in depressive symptoms (measured at Month 12)
Reduction in depressive symptoms; measured at Month 12
Not Provided
Not Provided
Antidepressant Medication for Reducing HIV Risk Behavior in Depressed Intravenous Drug Users
Maintaining HIV Risk Reduction Among Needle Exchangers
This study will evaluate the effectiveness of antidepressant medication treatment in reducing HIV risk behaviors in intravenous drug users with depression.

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.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Depression
  • Substance-Related Disorders
  • HIV Infections
Drug: Antidepressant Medication
Not Provided
Hayaki J, Stein MD, Lassor JA, Herman DS, Anderson BJ. Adversity among drug users: relationship to impulsivity. Drug Alcohol Depend. 2005 Apr 4;78(1):65-71.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2004
Not Provided

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
R01MH062719( U.S. NIH Grant/Contract )
R01MH062719 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Not Provided
Michael Stein, M.D./Principal Investigator, RI Hospital
Butler Hospital
National Institute of Mental Health (NIMH)
Principal Investigator: Michael Stein, MD Rhode Island Hospital
Study Director: Penelope Dennehy, MD Rhode Island Hospital
Butler Hospital
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP