A Laboratory Model for Heroin Abuse Medications - 8

A Laboratory Model for Heroin Abuse Medications

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."

Study Overview

• Status: Completed
• Conditions: Substance-Related Disorders; Opioid-Related Disorders; Heroin Dependence
• Intervention / Treatment: Drug: opiates

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
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University
    • New York, New York, United States, 10032
      • New York State Psychiatric Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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; oxycodone; buprenorphine; methadone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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..	90 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective responses	Four questionnaires were used to assess subjective effects	90 min

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: National Institute on Drug Abuse (NIDA)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 1995
• Primary Completion (Actual): November 1, 2005
• Study Completion (Actual): November 1, 2005

Study Registration Dates

• First Submitted: September 20, 1999
• First Submitted That Met QC Criteria: September 20, 1999
• First Posted (Estimate): September 21, 1999

Study Record Updates

• Last Update Posted (Actual): July 5, 2017
• Last Update Submitted That Met QC Criteria: July 3, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: heroin, opioid disorders, substance related disorders
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Narcotic-Related Disorders; Substance-Related Disorders; Disease; Opioid-Related Disorders; Heroin Dependence; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Narcotic Antagonists; Respiratory System Agents; Antitussive Agents; Fentanyl; Buprenorphine; Morphine; Oxycodone; Methadone
• Other Study ID Numbers: #4857/5982R; 5P50DA009236-18 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No