Back to resultsEffects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide - 3
Primary Purpose
Opioid-Related Disorders, Substance-Related Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
30% N2O
0.2% isoflurane
0.4% isoflurane
100% oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-Related Disorders focused on measuring nitrous oxide, isoflurane, subjective effects, psychomotor, healthy volunteer, drug interaction
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 5
Arm 6
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Placebo
30% N2O
0.2% isoflurane
0.4% isoflurane
0.2% isoflurane + 30% N2O
0.4% isoflurane + 30% N2O
Arm Description
Subjects inhale 100% oxygen
Subjects inhale 30% N2O
Subjects inhale 0.2% isoflurane
Subjects inhale 0.4% isoflurane
Subjects will inhale a combination of 0.2% isoflurane and 30% N2O
Subjects will inhale a combination of 0.4% isoflurane and 30% N2O
Outcomes
Primary Outcome Measures
Logical reasoning test
Free recall memory test
Auditory reaction time
Digit symbol substitution test
Secondary Outcome Measures
Full Information
NCT ID
NCT00000251
First Posted
September 20, 1999
Last Updated
November 30, 2015
Sponsor
University of Chicago
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00000251
Brief Title
Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide - 3
Official Title
Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
April 1994 (undefined)
Primary Completion Date
January 1996 (Actual)
Study Completion Date
January 1996 (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 evaluate the acute and residual effects of subanesthetic concentrations of isoflurane/nitrous oxide combinations 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
nitrous oxide, isoflurane, subjective effects, psychomotor, healthy volunteer, drug interaction
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
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects inhale 100% oxygen
Arm Title
30% N2O
Arm Type
Active Comparator
Arm Description
Subjects inhale 30% N2O
Arm Title
0.2% isoflurane
Arm Type
Active Comparator
Arm Description
Subjects inhale 0.2% isoflurane
Arm Title
0.4% isoflurane
Arm Type
Active Comparator
Arm Description
Subjects inhale 0.4% isoflurane
Arm Title
0.2% isoflurane + 30% N2O
Arm Type
Active Comparator
Arm Description
Subjects will inhale a combination of 0.2% isoflurane and 30% N2O
Arm Title
0.4% isoflurane + 30% N2O
Arm Type
Active Comparator
Arm Description
Subjects will inhale a combination of 0.4% isoflurane and 30% N2O
Intervention Type
Drug
Intervention Name(s)
30% N2O
Intervention Type
Drug
Intervention Name(s)
0.2% isoflurane
Intervention Type
Drug
Intervention Name(s)
0.4% isoflurane
Intervention Type
Other
Intervention Name(s)
100% oxygen
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Logical reasoning test
Time Frame
15 & 30 min inhalation and 5, 30, & 60 min post inhalation
Title
Free recall memory test
Time Frame
15 & 30 min inhalation and 5, 30, & 60 min post inhalation
Title
Auditory reaction time
Time Frame
15 & 30 min inhalation and 5,30 & 60 min post inhalation
Title
Digit symbol substitution test
Time Frame
2,15 & 30 min inhalation and 5,30 & 60 min post inhalation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
32 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:
PubMed Identifier
8712393
Citation
Zacny JP, Yajnik S, Lichtor JL, Klafta JM, Young CJ, Thapar P, Rupani G, Coalson DW, Apfelbaum JL. The acute and residual effects of subanesthetic concentrations of isoflurane/nitrous oxide combinations on cognitive and psychomotor performance in healthy volunteers. Anesth Analg. 1996 Jan;82(1):153-7. doi: 10.1097/00000539-199601000-00028.
Results Reference
background
PubMed Identifier
29610659
Citation
Whelan J, Hackshaw A, McTiernan A, Grimer R, Spooner D, Bate J, Ranft A, Paulussen M, Juergens H, Craft A, Lewis I. Survival is influenced by approaches to local treatment of Ewing sarcoma within an international randomised controlled trial: analysis of EICESS-92. Clin Sarcoma Res. 2018 Mar 30;8:6. doi: 10.1186/s13569-018-0093-y. eCollection 2018.
Results Reference
derived
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Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide - 3
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