A Laboratory Model for Heroin Abuse Medications - 8

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Laboratory Model for Heroin Abuse Medications

Conditions
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Heroin Dependence, Opioid-Related Disorders, Substance-Related Disorders

Intervention / Treatment
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* Drug: opiates


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opiates<br>Opiate-dependent individuals who were currently not seeking treatment for their drug use, completed the 6-week protocol. | Drug: opiates<br>* prescription opioids<br>* Other names: methadone;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heroin, opioid disorders, substance related disorders