Brief Introductory Therapy for Opioid Dependence
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ClinicalTrials.gov Identifier: NCT00406484 |
Recruitment Status
:
Completed
First Posted
: December 4, 2006
Last Update Posted
: January 16, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Opiate Dependence HIV Infections | Behavioral: Standard drug counseling Behavioral: BDRC | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 51 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Brief Introductory Therapy for Opioid Dependence |
Study Start Date : | September 2004 |
Actual Primary Completion Date : | September 2009 |
Actual Study Completion Date : | September 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Behavioral Drug and HIV Risk Reduction Counseling (BDRC)
|
Behavioral: BDRC
Behavioral Drug and HIV Risk Reduction Counseling, individual once or twice weekly sessions
|
Active Comparator: 2
Standard drug counseling
|
Behavioral: Standard drug counseling
Individual drug counseling
|
- Maximum number of consecutive weeks of opiate abstinence achieved during treatment [ Time Frame: 12 weeks ]
- Overall proportion of opiate negative urines tests in each treatment group [ Time Frame: 12 weeks ]
- Reduction in HIV risk behaviors [ Time Frame: 12 weeks ]
- Improvements in social, employment, legal, medical and psychiatric functioning [ Time Frame: 12 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- opioid dependence
Exclusion Criteria:
- suicide or homicide risk
- psychiatric disorder requiring medication treatment
- life threatening or unstable medical problems

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): NCT00406484
United States, Connecticut | |
Methadone Research Unit, The APT Foundation, Inc. | |
New Haven, Connecticut, United States, 06519 | |
Yale University School of Medicine | |
New Haven, Connecticut, United States, 06519 |
Principal Investigator: | Marek C Chawarski, Ph.D. | Yale University |
Responsible Party: | Marek Cezary Chawarski, Associate Professor, Yale University |
ClinicalTrials.gov Identifier: | NCT00406484 History of Changes |
Other Study ID Numbers: |
2R01DA013108-04 ( U.S. NIH Grant/Contract ) |
First Posted: | December 4, 2006 Key Record Dates |
Last Update Posted: | January 16, 2014 |
Last Verified: | January 2014 |
Keywords provided by Marek Cezary Chawarski, Yale University:
Methadone Counseling HIV risk reduction HIV Seronegativity |
Additional relevant MeSH terms:
HIV Infections Opioid-Related Disorders Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |