Cognitive Behavioral Stress Management for HIV+ Drug Abusers
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ClinicalTrials.gov Identifier: NCT00722644 |
Recruitment Status
:
Completed
First Posted
: July 25, 2008
Last Update Posted
: January 11, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV/AIDS Drug Abuse Alcohol Abuse | Behavioral: Cognitive Behavioral Stress Management | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 450 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single |
Primary Purpose: | Treatment |
Official Title: | Cognitive Behavioral Treatment of HIV+ Drug Abusers |
Study Start Date : | September 1999 |
Study Completion Date : | August 2007 |
- To evaluate if CBSM-RDA produces therapeutic improvement in distress and quality of life indices to a greater extent than HPC.
- SPECIFIC AIM 2: To evaluate if CBSM-RDA reduces drug abuse relapse to a greater extent than HPC.
- SPECIFIC AIM 3: To evaluate if CBSM-RDA reduces unsafe sex to a greater extent than HPC.
- SPECIFIC AIM 4: To evaluate if CBSM-RDA enhances CART adherence to a greater extent than HPC.
- SPECIFIC AIM 5: To evaluate if CBSM-RDA enhances health status to a greater extent than HPC.
- SPECIFIC AIM 6: To evaluate the extent to which key variables may mediate the relationships between our intervention and endpoints.
- SPECIFIC AIM 7: To evaluate the extent to which key variables moderate the relationships between our intervention and endpoints.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
- >18, but <60 years of age
- fluency in spoken English which is required to complete assessments and to participate in the intervention groups;
- acknowledgement of HIV seropositivity and willingness to be tested to confirm this serostatus;
- currently not cognitively impaired since cognitive impairment may compromise the ability to comprehend and participate in the assessment and intervention;
- currently not showing symptoms of a major psychiatric disorder/ including psychosis, or a high risk for suicidality since these conditions might compromise ability to comprehend and participate in the assessment and intervention; and
- classification as a "Recovering Drug Abusers" (RDAs; 30 days free of substances, 1-36 months recovery from alcohol and other drugs).

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 ClinicalTrials.gov identifier (NCT number): NCT00722644
Principal Investigator: | Robert M. Malow, PhD | Florida International University |
ClinicalTrials.gov Identifier: | NCT00722644 History of Changes |
Other Study ID Numbers: |
DA13802 |
First Posted: | July 25, 2008 Key Record Dates |
Last Update Posted: | January 11, 2017 |
Last Verified: | July 2008 |
Keywords provided by National Institute on Drug Abuse (NIDA):
HIV Medication Adherence Stress Management CD4/Viral Loads Cognitive Behavioral Treatment |
Additional relevant MeSH terms:
Alcoholism Substance-Related Disorders Alcohol-Related Disorders Chemically-Induced Disorders Mental Disorders |