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HIV Counseling Intervention for Methadone-Maintained Patients - 2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00061100
Recruitment Status : Completed
First Posted : May 22, 2003
Last Update Posted : April 1, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate HIV counseling intervention for Methadone-Maintained Patients.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Behavioral: Behavior Therapy-RISE Behavioral: Standard prevention Education Phase 1

Detailed Description:
The purpose of this proposal is to evaluate, in methadone-maintained patients the association between an ADHD diagnosis and high-risk HIV/Hepatitis behavior. In addition, the investigators would like to determine whether a new manually-guided HIV intervention; RISE: Reduce high risk Intravenous drug use and unsafe Sexual Encounters is superior to standard HIV/Hepatitis psycho-education.

Study Design

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
Primary Completion Date : October 2003
Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. AIDS risk behavior based on the Risk Behavior Assessment [ Time Frame: assessed monthly during 2 months of study or length of participation ]

Eligibility Criteria

Information from the National Library of Medicine

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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
Contacts and Locations

Information from the National Library of Medicine

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
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Principal Investigator: Frances R Levin, M.D. Research Foundation for Mental Hygiene, Inc.
More Information

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:
methadone maintenance

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents