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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Butler Hospital
ClinicalTrials.gov Identifier:
NCT00183768
First received: September 14, 2005
Last updated: August 20, 2013
Last verified: August 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Antidepressant Treatment to Reduce HIV Risk Among IDUs

Resource links provided by NLM:


Further study details as provided by Butler Hospital:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Butler Hospital
Investigators
Principal Investigator: Michael Stein, MD Rhode Island Hospital
Study Director: Penelope Dennehy, MD Rhode Island Hospital
  More Information

Publications:
Responsible Party: Michael Stein, M.D./Principal Investigator, RI Hospital
ClinicalTrials.gov Identifier: NCT00183768     History of Changes
Other Study ID Numbers: R01 MH61141, R01MH061141, DAHBR AZ-M
Study First Received: September 14, 2005
Last Updated: August 20, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on August 28, 2014