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OpenTrials
Completed

NCT Number: NCT00000273

A Laboratory Model for Heroin Abuse Medications - 8

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."

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Columbia University, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Opiates

Drug

prescription opioids

Other names: morphine, fentanyl, buprenorphine, oxycodone, methadone

Primary outcomes

  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 outcomes

  1. Subjective responses

    Time frame: 90 min

    Four questionnaires were used to assess subjective effects

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

A Laboratory Model for Heroin Abuse Medications

Important dates

Study start
1995
Primary completion
2005
Study completion
2005
First posted
Sep 21, 1999
Registry last updated
Jul 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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