Back to resultsEffects of Subanesthetic Concentrations of Nitrous Oxide - 1
Primary Purpose
Opioid-Related Disorders, Substance-Related Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
20% N2O
30% N2O
40% N2O
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-Related Disorders focused on measuring nitrous oxide, 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
No Intervention
Active Comparator
Active Comparator
Active Comparator
Arm Label
Control
20% N2O
30% N2O
40% N2O
Arm Description
Subject inhaled 0% N2O for 40 minutes with cold immersion at 10 and 30 minutes
Subject inhaled 20% N2O for 40 minutes with cold immersion at 10 & 30 minutes
Subject inhaled 30% N2O for 40 minutes with cold immersion at 10 and 30 minutes
Subject inhaled 40% N2O for 40 minutes with cold immersion at 10 and 30 minutes
Outcomes
Primary Outcome Measures
Pain intensity
Subjects immersed non-dominant arm for 3 minutes twice in 2-3 degree C water while inhaling 0 (placebo), 20, 30, or 40% N2O for a total of 40 minutes
Secondary Outcome Measures
Full Information
NCT ID
NCT00000249
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
NCT00000249
Brief Title
Effects of Subanesthetic Concentrations of Nitrous Oxide - 1
Official Title
Effects of Subanesthetic Concentrations of Nitrous Oxide
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 1993 (undefined)
Primary Completion Date
June 1995 (Actual)
Study Completion Date
June 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 examine effects of subanesthetic concentrations of nitrous oxide on cold-pressor pain in humans.
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, subjective effects, healthy volunteer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subject inhaled 0% N2O for 40 minutes with cold immersion at 10 and 30 minutes
Arm Title
20% N2O
Arm Type
Active Comparator
Arm Description
Subject inhaled 20% N2O for 40 minutes with cold immersion at 10 & 30 minutes
Arm Title
30% N2O
Arm Type
Active Comparator
Arm Description
Subject inhaled 30% N2O for 40 minutes with cold immersion at 10 and 30 minutes
Arm Title
40% N2O
Arm Type
Active Comparator
Arm Description
Subject inhaled 40% N2O for 40 minutes with cold immersion at 10 and 30 minutes
Intervention Type
Drug
Intervention Name(s)
20% N2O
Intervention Description
20% inhaled N2O
Intervention Type
Drug
Intervention Name(s)
30% N2O
Intervention Description
30% inhaled N2O
Intervention Type
Drug
Intervention Name(s)
40% N2O
Intervention Description
40% inhaled N2O
Primary Outcome Measure Information:
Title
Pain intensity
Description
Subjects immersed non-dominant arm for 3 minutes twice in 2-3 degree C water while inhaling 0 (placebo), 20, 30, or 40% N2O for a total of 40 minutes
Time Frame
during cold test at 10 min & 30 min of inhalation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
37 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
7667348
Citation
Pirec V, Patterson TH, Thapar P, Apfelbaum JL, Zacny JP. Effects of subanesthetic concentrations of nitrous oxide on cold-pressor pain in humans. Pharmacol Biochem Behav. 1995 Jun-Jul;51(2-3):323-9. doi: 10.1016/0091-3057(94)00388-y.
Results Reference
background
Learn more about this trial
Effects of Subanesthetic Concentrations of Nitrous Oxide - 1
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