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A Laboratory Model for Heroin Abuse Medications - 8

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00000273
First received: September 20, 1999
Last updated: July 3, 2017
Last verified: June 2017
  Purpose
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."

Condition Intervention Phase
Heroin Dependence Opioid-Related Disorders Substance-Related Disorders Drug: opiates Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Laboratory Model for Heroin Abuse Medications

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Amount drug self-administered [ Time Frame: 90 minutes ]
    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 [ Time Frame: 90 min ]
    Four questionnaires were used to assess subjective effects


Enrollment: 8
Study Start Date: August 1995
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Opiates
Opiate-dependent individuals who were currently not seeking treatment for their drug use, completed the 6-week protocol.
Drug: opiates
prescription opioids
Other Names:
  • morphine
  • fentanyl
  • buprenorphine
  • oxycodone
  • methadone

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.
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criterion

  1. DSM IV criteria for opioid dependence
  2. No major mood, psychotic, or anxiety disorder
  3. Physically healthy
  4. Able to perform study procedures
  5. 21-45 years of age
  6. Current use of i.v. heroin in amounts/frequencies
  7. Not seeking treatment for opioid dependence

Exclusion Criterion

  1. DSM IV criteria for dependence on drugs other
  2. Participants requesting treatment
  3. Participants on parole or probation
  4. Pregnancy or lactation
  5. Birth, miscarriage or abortion with 6 months
  6. Recent history of or current significant violent behavior
  7. 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
  8. Hepatitis with SGOT or SGPT > 3 times normal
  9. Significant suicide risk
  10. Current or history of chronic pain
  11. Sensitivity, allergy, or contraindication to opioids
  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: NCT00000273

Locations
United States, New York
Columbia University
New York, New York, United States, 10032
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Herbert Kleber, M.D. New York State Psychiatric Institute
  More Information

Publications:
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00000273     History of Changes
Other Study ID Numbers: #4857/5982R
5P50DA009236-18 ( U.S. NIH Grant/Contract )
Study First Received: September 20, 1999
Last Updated: July 3, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by New York State Psychiatric Institute:
heroin, opioid disorders, substance related disorders

Additional relevant MeSH terms:
Disease
Substance-Related Disorders
Opioid-Related Disorders
Heroin Dependence
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Opiate Alkaloids
Heroin
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists

ClinicalTrials.gov processed this record on September 21, 2017