Back to resultsIsoflurane at Subanesthetic Concentrations - 6
Primary Purpose
Opioid-Related Disorders, Substance-Related Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
40% Nitrous oxide
Sham comparator
0.2% isoflurane
0.4% isoflurane
0.6% isoflurane
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-Related Disorders focused on measuring isoflurane, general anesthetic, inhalant, subjective effects, healthy volunteer
Eligibility Criteria
Please contact site for information.
Sites / Locations
- University of Chicago, Anesthesia & Critical Care
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Sham Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
0% isoflurane
0.2% isoflurane
0.4% isoflurane
0.6% isoflurane
Arm Description
Outcomes
Primary Outcome Measures
Pain response
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00000254
First Posted
September 20, 1999
Last Updated
May 26, 2015
Sponsor
University of Chicago
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00000254
Brief Title
Isoflurane at Subanesthetic Concentrations - 6
Official Title
Isoflurane at Subanesthetic Concentrations
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 1995 (undefined)
Primary Completion Date
September 1995 (Actual)
Study Completion Date
September 1995 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders, Substance-Related Disorders
Keywords
isoflurane, general anesthetic, inhalant, subjective effects, healthy volunteer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0% isoflurane
Arm Type
Sham Comparator
Arm Title
0.2% isoflurane
Arm Type
Active Comparator
Arm Title
0.4% isoflurane
Arm Type
Active Comparator
Arm Title
0.6% isoflurane
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
40% Nitrous oxide
Intervention Description
Used as pain assay positive control
Intervention Type
Other
Intervention Name(s)
Sham comparator
Intervention Description
0% isoflurane in oxygen
Intervention Type
Drug
Intervention Name(s)
0.2% isoflurane
Intervention Type
Drug
Intervention Name(s)
0.4% isoflurane
Intervention Type
Drug
Intervention Name(s)
0.6% isoflurane
Primary Outcome Measure Information:
Title
Pain response
Description
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.
Time Frame
Post inhalation
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Please contact site for information.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Zacny, Ph.D.
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago, Anesthesia & Critical Care
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Anesthesiology, 1995, 83: A287
Results Reference
background
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Isoflurane at Subanesthetic Concentrations - 6
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