HIV Counseling Intervention for Methadone-Maintained Patients - 2
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ClinicalTrials.gov Identifier: NCT00061100 |
Recruitment Status
:
Completed
First Posted
: May 22, 2003
Last Update Posted
: April 1, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Opioid-Related Disorders | Behavioral: Behavior Therapy-RISE Behavioral: Standard prevention Education | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | HIV Counseling Intervention for Methadone-Maintained Patients |
Study Start Date : | October 1999 |
Actual Primary Completion Date : | October 2003 |
Actual Study Completion Date : | October 2003 |

Arm | Intervention/treatment |
---|---|
Experimental: RISE intervention
Targeted RISE intervention- Behavior therapy Rise
|
Behavioral: Behavior Therapy-RISE
manually-guided HIV intervention RISE: Reduce high risk Intravenous drug use and unsafe Sexual Encounter
|
Active Comparator: Standard Education
Education intervention. Standard prevention education
|
Behavioral: Standard prevention Education
standard psychosocial Education for HIV/hepatitis prevention
|
- AIDS risk behavior based on the Risk Behavior Assessment [ Time Frame: assessed monthly during 2 months of study or length of participation ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Must meet DSM-IV criteria for opiate dependence and currently in methadone maintenance treatment
- Able to give informed consent and capable of complying with study procedures
- Women who are of childbearing age and/or pregnant may be included
- Individuals who are HIV-positive or have Acquired Immunodeficiency Syndrome may be included
- Patients who demonstrate moderate to high HIV risk behaviors will be included
- Patients with low to no HIV risk behaviors will be excluded
- Patients receiving a stable dose of methadone for three weeks will be included
Exclusion Criteria:
- Currently meets DSM-IV criteria for current Axis I psychiatric disorders (other than ADHD or substance abuse) which requires medical intervention, i.e., active suicide ideation, active psychosis, anxiety disorders, depression requiring hospitalization
- Patients who have exhibited suicidal or homicidal behavior within the past two years
- HIV positive patients must have knowledge of their status for a minimum of three weeks

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): NCT00061100
United States, New York | |
Research Foundation for Mental Hygiene, Inc. | |
New York, New York, United States, 10032 |
Principal Investigator: | Frances R Levin, M.D. | Research Foundation for Mental Hygiene, Inc. |
Responsible Party: | New York State Psychiatric Institute |
ClinicalTrials.gov Identifier: | NCT00061100 History of Changes |
Other Study ID Numbers: |
#3884 R01DA011444 ( U.S. NIH Grant/Contract ) 3884 ( Other Identifier: NYSPI IRB ) |
First Posted: | May 22, 2003 Key Record Dates |
Last Update Posted: | April 1, 2015 |
Last Verified: | March 2015 |
Keywords provided by New York State Psychiatric Institute:
HIV methadone maintenance |
Additional relevant MeSH terms:
Opioid-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Methadone Analgesics, Opioid Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Antitussive Agents Respiratory System Agents |