Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

September 14, 2005
August 20, 2013
September 1999
Not Provided
HIV risk behavior; measured at Month 9
Same as current
Complete list of historical versions of study NCT00183768 on ClinicalTrials.gov Archive Site
Depression severity; measured at Month 9
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Depression
  • Substance-Related Disorders
  • Behavioral: Cognitive Behavioral Therapy
  • Behavioral: Psychopharmacology
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
175
February 2003
Not Provided

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00183768
R01 MH61141, R01MH061141, DAHBR AZ-M
Not Provided
Michael Stein, M.D./Principal Investigator, RI Hospital
Butler Hospital
National Institute of Mental Health (NIMH)
Principal Investigator: Michael Stein, MD Rhode Island Hospital
Study Director: Penelope Dennehy, MD Rhode Island Hospital
Butler Hospital
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP