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

Primary Purpose

Depression, Substance-Related Disorders, HIV Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Antidepressant Medication
Sponsored by
Butler Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Injection Drug Use, HIV Risk Behavior, HIV Seronegativity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Rhode Island Hospital

Outcomes

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)

Full Information

First Posted
September 26, 2005
Last Updated
August 20, 2013
Sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00228007
Brief Title
Antidepressant Medication for Reducing HIV Risk Behavior in Depressed Intravenous Drug Users
Official Title
Maintaining HIV Risk Reduction Among Needle Exchangers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Substance-Related Disorders, HIV Infections
Keywords
Injection Drug Use, HIV Risk Behavior, HIV Seronegativity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
265 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Antidepressant Medication
Primary Outcome Measure Information:
Title
Maintenance of HIV risk-free drug behavior (measured at Month 12)
Secondary Outcome Measure Information:
Title
Reduction in depressive symptoms (measured at Month 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 Pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Stein, MD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Penelope Dennehy, MD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15769559
Citation
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. doi: 10.1016/j.drugalcdep.2004.09.002.
Results Reference
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Antidepressant Medication for Reducing HIV Risk Behavior in Depressed Intravenous Drug Users

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