A Laboratory Model for Heroin Abuse Medications - 8

Substance-Related Disorders Clinical Trial

Official title:

A Laboratory Model for Heroin Abuse Medications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000273
• Other study ID #: #4857/5982R
• Secondary ID: 5P50DA009236-18
• Status: Completed
• Phase: Phase 2
• First received: September 20, 1999
• Last updated: July 3, 2017
• Start date: August 1995
• Est. completion date: November 2005

Study information

• Verified date: June 2017
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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."

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Heroin Dependence
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

Drug:
• opiates
prescription opioids

Locations

Country	Name	City	State
United States	Columbia University	New York	New York
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Epub 2007 Jun 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Subjective responses	Four questionnaires were used to assess subjective effects	90 min