Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-1 - 4
Information source: National Institute on Drug Abuse (NIDA)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heroin Dependence; Opioid-Related Disorders
Intervention: Opioid-Related Disorders (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute on Drug Abuse (NIDA) Official(s) and/or principal investigator(s):
Leslie Amass, Ph.D., Principal Investigator, Affiliation: University of Colorado at Denver and Health Sciences Center
Summary
The purpose of this study is to assess the abuse liability and examine the reinforcing
effects of intravenous buprenorphine and buprenorphine/naloxone combinations in
buprenorphine-naloxone maintained volunteers
Clinical Details
Official title: Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-1
Study design: Treatment, Double-Blind, Placebo Control
Primary outcome: Subjective dose estimateObserved withdrawal rating Opioid agonist rating Opioid antagonist rating Pupil diameter Analog rating scale for drug effects Drug effect characteristics Drug/Money Preferences
Detailed description:
Ongoing study - results not available at this time
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Individuals must be at least 18 yrs of age, currently opioid dependent and meet FDA critera
for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may
also be present. Individuals must be healthy despite drug dependency and have a history of
IV opioid use.
Exclusion Criteria:
Individuals with evidence of anti active DSM-IV Axis I psychiatric disorder (e. g.
psychosis, manic-depressive illness, organic psychiatric disorders), significant medical
illness (e. g. liver or cardiovascular disease) or pregnant female subjects are excluded
from study participation.
Locations and Contacts
University of Colorado Health Sciences Center, Denver, Colorado 80206, United States
Additional Information
Starting date: April 1999
Last updated: November 3, 2005
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