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

NCT ID: NCT00228007

Last Updated: 2013-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 265 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-30
• Study Completion Date: 2004-09-30

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.

Conditions

Depression; Substance-Related Disorders; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Antidepressant Medication

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Butler Hospital

OTHER

Sponsor Role: lead

Responsible Party

RI Hospital

Principal Investigators

Michael Stein, MD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Penelope Dennehy, MD

Role: STUDY_DIRECTOR

Rhode Island Hospital

Locations

Rhode Island Hospital

Providence, Rhode Island, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15769559 (View on PubMed)

Other Identifiers

R01MH062719

Identifier Type: NIH

Identifier Source: secondary_id

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DAHBR AZ-Q

Identifier Type: -

Identifier Source: secondary_id

R01MH062719

Identifier Type: NIH

Identifier Source: org_study_id

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