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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Butler Hospital
ClinicalTrials.gov Identifier:
NCT00228007
First received: September 26, 2005
Last updated: August 20, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Depression
Substance-Related Disorders
HIV Infections
Drug: Antidepressant Medication
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Maintaining HIV Risk Reduction Among Needle Exchangers

Resource links provided by NLM:


Further study details as provided by Butler Hospital:

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

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

Estimated Enrollment: 265
Study Start Date: September 2000
Study Completion Date: September 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00228007

Locations
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Butler Hospital
Investigators
Principal Investigator: Michael Stein, MD Rhode Island Hospital
Study Director: Penelope Dennehy, MD Rhode Island Hospital
  More Information

Publications:
Responsible Party: Michael Stein, M.D./Principal Investigator, RI Hospital
ClinicalTrials.gov Identifier: NCT00228007     History of Changes
Other Study ID Numbers: R01 MH62719, R01MH062719, DAHBR AZ-Q
Study First Received: September 26, 2005
Last Updated: August 20, 2013
Health Authority: United States: Federal Government

Keywords provided by Butler Hospital:
Injection Drug Use
HIV Risk Behavior
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Depression
Depressive Disorder
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
Slow Virus Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014