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Isoflurane at Subanesthetic Concentrations - 6

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000254
First Posted: September 21, 1999
Last Update Posted: May 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Chicago
  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
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 34 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria
Please contact site for information.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000254


Locations
United States, Illinois
University of Chicago, Anesthesia & Critical Care
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: James Zacny, Ph.D. University of Chicago
  More Information

Publications:
Anesthesiology, 1995, 83: A287

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00000254     History of Changes
Other Study ID Numbers: NIDA-08391-6
R01DA008391 ( U.S. NIH Grant/Contract )
R01-08391-6
First Submitted: September 20, 1999
First Posted: September 21, 1999
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by University of Chicago:
isoflurane
general anesthetic
inhalant
subjective effects
healthy volunteer

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