Clinical trial NCT00228007: Antidepressant Medication for Reducing HIV Risk Behavior in Depressed Intravenous Drug Users
Official title: Maintaining HIV Risk Reduction Among Needle Exchangers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Substance-Related Disorders
HIV Infections
Keywords: Injection Drug Use
HIV Risk Behavior
HIV Seronegativity
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-28
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Maintenance of HIV risk-free drug behavior (measured at Month 12)
Secondary outcomes:
measure: Reduction in depressive symptoms (measured at Month 12)
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Michael Stein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rhode Island Hospital
name: Penelope Dennehy, MD
role: STUDY_DIRECTOR
References:
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.