Cognitive Behavioral Therapy Combined With Antidepressants to Reduce HIV Risk and Drug Relapse Among Depressed Intravenous Drug Users
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | September 14, 2005 | ||||||||
| Last Updated Date | December 17, 2007 | ||||||||
| Start Date ICMJE | September 1999 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
HIV risk behavior; measured at Month 9 | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00183768 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Depression severity; measured at Month 9 | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Cognitive Behavioral Therapy Combined With Antidepressants to Reduce HIV Risk and Drug Relapse Among Depressed Intravenous Drug Users | ||||||||
| Official Title ICMJE | Antidepressant Treatment to Reduce HIV Risk Among IDUs | ||||||||
| 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. |
||||||||
| 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 ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE |
|
||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * |
|
||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 175 | ||||||||
| Completion Date | February 2003 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00183768 | ||||||||
| Other Study ID Numbers ICMJE | R01 MH61141, DAHBR AZ-M | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Michael Stein, M.D./Principal Investigator, RI Hospital | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | December 2007 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||