Cognitive Behavioral Therapy Combined With Antidepressants to Reduce HIV Risk and Drug Relapse Among Depressed Intravenous Drug Users

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00183768
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : August 22, 2013
National Institute of Mental Health (NIMH)
Information provided by:
Butler Hospital

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.

Condition or disease Intervention/treatment Phase
HIV Infections Depression Substance-Related Disorders Behavioral: Cognitive Behavioral Therapy Behavioral: Psychopharmacology Phase 3

Detailed Description:

Depression is common among injection drug users (IDUs); it is estimated that up to 50% of IDUs meet the diagnostic criteria for major depressive disorder, a severe form of depression. The combination of drug abuse and depression increases the likelihood of engaging in HIV high-risk behaviors such as unprotected sex and the use of unhygienic needles to inject drugs. Research has shown that IDUs who receive treatment for depression have lower rates of drug relapse and are less likely to engage in high-risk sexual behavior compared to IDUs who have not received treatment for depression. Combination treatment, which includes cognitive behavioral therapy (CBT) and antidepressant medication, has been shown to be the most effective treatment for depression. This study will evaluate the effectiveness of combination treatment in reducing HIV risk behaviors and drug relapse rates in cocaine or opiate addicted IDUs with a diagnosis of depression.

In this 9-month study, participants will be randomly assigned to either a combination treatment group or an assessment only group that will receive no treatment. Participants assigned to combination treatment will receive the antidepressant Celexa, and will attend 8 CBT sessions and 7 psychopharmacology sessions. Each CBT session will last about 60 minutes and each psychopharmacology session will last about 15 minutes. If a participant does not respond well to Celexa, Wellbutrin or Effexor may be taken instead. Participants in both groups will attend 4 study visits during which they will complete standardized psychological questionnaires and interviews to assess depression levels, drug use, and high-risk sexual behaviors. Blood will be drawn at baseline and Month 9 for HIV testing.

Study Type : Interventional  (Clinical Trial)
Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antidepressant Treatment to Reduce HIV Risk Among IDUs
Study Start Date : September 1999
Actual Study Completion Date : February 2003

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. HIV risk behavior; measured at Month 9

Secondary Outcome Measures :
  1. Depression severity; measured at Month 9

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00183768

United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Butler Hospital
National Institute of Mental Health (NIMH)
Principal Investigator: Michael Stein, MD Rhode Island Hospital
Study Director: Penelope Dennehy, MD Rhode Island Hospital

Publications of Results:
Responsible Party: Michael Stein, M.D./Principal Investigator, RI Hospital Identifier: NCT00183768     History of Changes
Other Study ID Numbers: R01MH061141 ( U.S. NIH Grant/Contract )
R01MH061141 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: August 22, 2013
Last Verified: August 2013

Keywords provided by Butler Hospital:
Cognitive Behavioral Treatment For Depression
Antidepressant Psychopharmacology
HIV Risk Behavior
Injection Drug Use

Additional relevant MeSH terms:
HIV Infections
Substance-Related Disorders
Behavioral Symptoms
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Chemically-Induced Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs