Back to resultsA Laboratory Model for Heroin Abuse Medications - 8
Primary Purpose
Heroin Dependence, Opioid-Related Disorders, Substance-Related Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
opiates
Sponsored by
About this trial
This is an interventional treatment trial for Heroin Dependence focused on measuring heroin, opioid disorders, substance related disorders
Eligibility Criteria
Inclusion Criterion DSM IV criteria for opioid dependence No major mood, psychotic, or anxiety disorder Physically healthy Able to perform study procedures 21-45 years of age Current use of i.v. heroin in amounts/frequencies Not seeking treatment for opioid dependence Exclusion Criterion DSM IV criteria for dependence on drugs other Participants requesting treatment Participants on parole or probation Pregnancy or lactation Birth, miscarriage or abortion with 6 months Recent history of or current significant violent behavior Current major Axis I psychopathology, other than heroin dependence ( e.g., mood disorder with functional impairment or suicide risk, schizophrenia), which might interfere with ability to participate in the study Hepatitis with SGOT or SGPT > 3 times normal Significant suicide risk Current or history of chronic pain Sensitivity, allergy, or contraindication to opioids
Sites / Locations
- Columbia University
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Opiates
Arm Description
Opiate-dependent individuals who were currently not seeking treatment for their drug use, completed the 6-week protocol.
Outcomes
Primary Outcome Measures
Amount drug self-administered
All of the participants received all of the drugs tested; drugs and doses were administered in non-systematic order. Participants were instructed to choose between the dose that they had received during the sample session or another reward..
Secondary Outcome Measures
Subjective responses
Four questionnaires were used to assess subjective effects
Full Information
NCT ID
NCT00000273
First Posted
September 20, 1999
Last Updated
July 3, 2017
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00000273
Brief Title
A Laboratory Model for Heroin Abuse Medications - 8
Official Title
A Laboratory Model for Heroin Abuse Medications
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
August 1995 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effects of treatment medications (methadone, buprenorphine, LAAM, naltrexone, naltrexone microcapsules, and methoclocinnamox) on I.V. and smoked heroin self-administration."
Detailed Description
Abuse of prescription opioid medications has increased dramatically in the U.S. during the past decade, as indicated by a variety of epidemiological sources. However, few studies have systematically examined the relative reinforcing effects of commonly abused opioid medications. The current inpatient study was designed to compare the effects of intravenously delivered fentanyl , oxycodone, morphine, buprenorphine and heroin in morphine-maintained heroin abusers. All of the participants received all of the drugs tested; drugs and doses were administered in non-systematic order.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heroin Dependence, Opioid-Related Disorders, Substance-Related Disorders
Keywords
heroin, opioid disorders, substance related disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Opiates
Arm Type
Experimental
Arm Description
Opiate-dependent individuals who were currently not seeking treatment for their drug use, completed the 6-week protocol.
Intervention Type
Drug
Intervention Name(s)
opiates
Other Intervention Name(s)
morphine, fentanyl, buprenorphine, oxycodone, methadone
Intervention Description
prescription opioids
Primary Outcome Measure Information:
Title
Amount drug self-administered
Description
All of the participants received all of the drugs tested; drugs and doses were administered in non-systematic order. Participants were instructed to choose between the dose that they had received during the sample session or another reward..
Time Frame
90 minutes
Secondary Outcome Measure Information:
Title
Subjective responses
Description
Four questionnaires were used to assess subjective effects
Time Frame
90 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criterion
DSM IV criteria for opioid dependence
No major mood, psychotic, or anxiety disorder
Physically healthy
Able to perform study procedures
21-45 years of age
Current use of i.v. heroin in amounts/frequencies
Not seeking treatment for opioid dependence
Exclusion Criterion
DSM IV criteria for dependence on drugs other
Participants requesting treatment
Participants on parole or probation
Pregnancy or lactation
Birth, miscarriage or abortion with 6 months
Recent history of or current significant violent behavior
Current major Axis I psychopathology, other than heroin dependence ( e.g., mood disorder with functional impairment or suicide risk, schizophrenia), which might interfere with ability to participate in the study
Hepatitis with SGOT or SGPT > 3 times normal
Significant suicide risk
Current or history of chronic pain
Sensitivity, allergy, or contraindication to opioids
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert Kleber, M.D.
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17581533
Citation
Comer SD, Sullivan MA, Whittington RA, Vosburg SK, Kowalczyk WJ. Abuse liability of prescription opioids compared to heroin in morphine-maintained heroin abusers. Neuropsychopharmacology. 2008 Apr;33(5):1179-91. doi: 10.1038/sj.npp.1301479. Epub 2007 Jun 20.
Results Reference
result
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