Clinical trial NCT00000273: A Laboratory Model for Heroin Abuse Medications - 8
Official title: A Laboratory Model for Heroin Abuse Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Keywords: heroin, opioid disorders, substance related disorders
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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."

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.

Eligibility criteria: 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

Primary outcomes:
measure: Amount drug self-administered
timeFrame: 90 minutes
Secondary outcomes:
measure: Subjective responses
timeFrame: 90 min
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Herbert Kleber, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.