Isoflurane at Subanesthetic Concentrations - 6

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00000254
First received: September 20, 1999
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To test the hypothesis that isoflurane at subanesthetic concentrations does not reduce cold-water immersion pain in healthy volunteers.


Condition Intervention Phase
Opioid-Related Disorders
Substance-Related Disorders
Drug: 40% Nitrous oxide
Other: Sham comparator
Drug: 0.2% isoflurane
Drug: 0.4% isoflurane
Drug: 0.6% isoflurane
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Isoflurane at Subanesthetic Concentrations

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Pain response [ Time Frame: Post inhalation ] [ Designated as safety issue: No ]
    Effects of inhaled isoflurane on pain from immersion of subject's arm in ice cold water. Nitrous oxide (40%) was used as a positive control to confirm sensitivity of the pain assay.


Enrollment: 10
Study Start Date: January 1995
Study Completion Date: September 1995
Primary Completion Date: September 1995 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: 0% isoflurane Drug: 40% Nitrous oxide
Used as pain assay positive control
Other: Sham comparator
0% isoflurane in oxygen
Active Comparator: 0.2% isoflurane Drug: 40% Nitrous oxide
Used as pain assay positive control
Drug: 0.2% isoflurane
Active Comparator: 0.4% isoflurane Drug: 40% Nitrous oxide
Used as pain assay positive control
Drug: 0.4% isoflurane
Active Comparator: 0.6% isoflurane Drug: 40% Nitrous oxide
Used as pain assay positive control
Drug: 0.6% isoflurane

  Eligibility

Ages Eligible for Study:   21 Years to 34 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00000254

Locations
United States, Illinois
University of Chicago, Anesthesia & Critical Care
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: James Zacny, Ph.D. University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00000254     History of Changes
Other Study ID Numbers: NIDA-08391-6, R01DA008391, R01-08391-6
Study First Received: September 20, 1999
Last Updated: July 23, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Isoflurane
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014