Cognitive Behavioral Therapy Combined With Antidepressants to Reduce HIV Risk and Drug Relapse Among Depressed Intravenous Drug Users
Antidepressant Treatment to Reduce HIV Risk Among IDUs
2 other identifiers
interventional
175
1 country
1
Brief Summary
This study will evaluate the effectiveness of combining cognitive behavioral therapy (CBT) and antidepressants in reducing HIV risk behavior and drug relapse rates in depressed intravenous drug users.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hiv-infections
Started Sep 1999
Typical duration for phase_3 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedAugust 22, 2013
August 1, 2013
September 14, 2005
August 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HIV risk behavior; measured at Month 9
Secondary Outcomes (1)
Depression severity; measured at Month 9
Interventions
Eligibility Criteria
You may qualify if:
- Meets DSM-IV criteria for major depression, dysthymia, substance-induced major depression, or major depression plus dysthymia
- Score of greater than 14 on the Hamilton Depression Rating Scale
- Involved in HIV risk behaviors
- Current opiate or cocaine use
- Basic proficiency in English
You may not qualify if:
- Current suicidal risk or ideation
- Current psychotic symptoms
- Simultaneous medical disorder that might make psychopharmacological treatment medically inadvisable
- History of bipolar disorder, schizophrenia, schizo-affective disorder, schizophreniform disorder, or paranoid disorder
- Currently taking other medications for depression
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Butler Hospitallead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Related Publications (3)
Stein MD, Herman DS, Solomon DA, Anthony JL, Anderson BJ, Ramsey SE, Miller IW. Adherence to treatment of depression in active injection drug users: the minerva study. J Subst Abuse Treat. 2004 Mar;26(2):87-93. doi: 10.1016/S0740-5472(03)00160-0.
PMID: 15050085RESULTStein MD, Solomon DA, Herman DS, Anthony JL, Ramsey SE, Anderson BJ, Miller IW. Pharmacotherapy plus psychotherapy for treatment of depression in active injection drug users. Arch Gen Psychiatry. 2004 Feb;61(2):152-9. doi: 10.1001/archpsyc.61.2.152.
PMID: 14757591RESULTStein MD, Solomon DA, Herman DS, Anderson BJ, Miller I. Depression severity and drug injection HIV risk behaviors. Am J Psychiatry. 2003 Sep;160(9):1659-62. doi: 10.1176/appi.ajp.160.9.1659.
PMID: 12944342RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Stein, MD
Rhode Island Hospital
- STUDY DIRECTOR
Penelope Dennehy, MD
Rhode Island Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 16, 2005
Study Start
September 1, 1999
Study Completion
February 1, 2003
Last Updated
August 22, 2013
Record last verified: 2013-08