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

Depression Clinical Trial

Official title:

Maintaining HIV Risk Reduction Among Needle Exchangers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00228007
• Other study ID #: R01MH062719
• Secondary ID: R01MH062719DAHBR
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2005
• Last updated: August 20, 2013
• Start date: September 2000
• Est. completion date: September 2004

Study information

• Verified date: August 2013
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• HIV Infections
• Substance-Related Disorders

Intervention

Drug:
• Antidepressant Medication

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maintenance of HIV risk-free drug behavior (measured at Month 12)
Secondary	Reduction in depressive symptoms (measured at Month 12)