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Cognitive Behavioral Therapy Combined With Antidepressants to Reduce HIV Risk and Drug Relapse Among Depressed Intravenous Drug Users
This study has been completed.
First Received: September 14, 2005   Last Updated: December 17, 2007   History of Changes
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00183768
  Purpose

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 Intervention Phase
HIV Infections
Depression
Substance-Related Disorders
Behavioral: Cognitive Behavioral Therapy
Behavioral: Psychopharmacology
Phase III

MedlinePlus related topics: AIDS Antidepressants Depression
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Antidepressant Treatment to Reduce HIV Risk Among IDUs

Further study details as provided by National Institute of Mental Health (NIMH):

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

Secondary Outcome Measures:
  • Depression severity; measured at Month 9

Estimated Enrollment: 175
Study Start Date: September 1999
Study Completion Date: February 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00183768

Locations
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Investigators
Principal Investigator: Michael Stein, MD Rhode Island Hospital
Study Director: Penelope Dennehy, MD Rhode Island Hospital
  More Information

Publications:
Responsible Party: RI Hospital ( Michael Stein, M.D./Principal Investigator )
Study ID Numbers: R01 MH61141, DAHBR AZ-M
Study First Received: September 14, 2005
Last Updated: December 17, 2007
ClinicalTrials.gov Identifier: NCT00183768     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Cognitive Behavioral Treatment For Depression
Antidepressant Psychopharmacology
HIV Risk Behavior
Injection Drug Use

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Depression
Acquired Immunodeficiency Syndrome
Psychotropic Drugs
Disorders of Environmental Origin
Depressive Disorder
Immunologic Deficiency Syndromes
Behavioral Symptoms
Virus Diseases
HIV Infections
Mental Disorders
Sexually Transmitted Diseases
Substance-Related Disorders
Mood Disorders
Retroviridae Infections
Antidepressive Agents

Additional relevant MeSH terms:
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Depression
Immune System Diseases
Acquired Immunodeficiency Syndrome
Psychotropic Drugs
Disorders of Environmental Origin
Infection
Depressive Disorder
Pharmacologic Actions
Immunologic Deficiency Syndromes
Behavioral Symptoms
Virus Diseases
Mental Disorders
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Mood Disorders
Substance-Related Disorders
Lentivirus Infections
Central Nervous System Agents
Retroviridae Infections
Antidepressive Agents

ClinicalTrials.gov processed this record on May 07, 2009