A Laboratory Model for Heroin Abuse Medications - 8

Sponsor

New York State Psychiatric Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00000273

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Locations

Arm

123

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Laboratory Model for Heroin Abuse Medications

Study Start Date :

Aug 1, 1995

Actual Primary Completion Date :

Nov 1, 2005

Actual Study Completion Date :

Nov 1, 2005

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Amount drug self-administered [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 [90 min]
Four questionnaires were used to assess subjective effects

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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