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A Laboratory Model for Heroin Abuse Medications - 8

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ClinicalTrials.gov Identifier: NCT00000273
Recruitment Status : Completed
First Posted : September 21, 1999
Last Update Posted : July 5, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute

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."

Condition or disease Intervention/treatment Phase
Heroin Dependence Opioid-Related Disorders Substance-Related Disorders Drug: opiates Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Laboratory Model for Heroin Abuse Medications
Study Start Date : August 1995
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. Subjective responses [ Time Frame: 90 min ]
    Four questionnaires were used to assess subjective effects



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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

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): 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

Publications of Results:
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 )
First Posted: September 21, 1999    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: June 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