HIV Counseling Intervention for Methadone-Maintained Patients - 2
This study has been completed.
Sponsor:
New York State Psychiatric Institute
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00061100
First received: May 21, 2003
Last updated: March 30, 2015
Last verified: March 2015
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to evaluate HIV counseling intervention for Methadone-Maintained Patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Opioid-Related Disorders |
Behavioral: Behavior Therapy-RISE Behavioral: Standard prevention Education |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | HIV Counseling Intervention for Methadone-Maintained Patients |
Resource links provided by NLM:
Further study details as provided by New York State Psychiatric Institute:
Primary Outcome Measures:
- AIDS risk behavior based on the Risk Behavior Assessment [ Time Frame: assessed monthly during 2 months of study or length of participation ] [ Designated as safety issue: No ]
| Enrollment: | 50 |
| Study Start Date: | October 1999 |
| Study Completion Date: | October 2003 |
| Primary Completion Date: | October 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00061100
Please refer to this study by its ClinicalTrials.gov identifier: NCT00061100
Locations
| 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)
Investigators
| 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 3884 |
| Study First Received: | May 21, 2003 |
| Last Updated: | March 30, 2015 |
| Health Authority: | United States: Federal Government |
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 |
ClinicalTrials.gov processed this record on September 27, 2016