Back to resultsDifferential Acute Tolerance Development to Effects of Nitrous Oxide - 7
Primary Purpose
Opioid-Related Disorders, Substance-Related Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nitrous oxide
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-Related Disorders focused on measuring nitrous oxide, acute tolerance, subjective effects, analgesia, psychomotor, 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 5
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
0% Nitrous oxide
10% nitrous oxide
20% nitrous oxide
30% nitrous oxide
40% nitrous oxide
Arm Description
Outcomes
Primary Outcome Measures
Pain intensity, pain bothersomeness
Subjects will inhale varying conc of nitrous oxide for 120 min with cold immersion of forearm at 25, 70, and 115 min and 40 min after inhalation. Pain intensity and bothersomeness will be assessed at each immersion.
Secondary Outcome Measures
Full Information
NCT ID
NCT00000255
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
NCT00000255
Brief Title
Differential Acute Tolerance Development to Effects of Nitrous Oxide - 7
Official Title
Differential Acute Tolerance Development to Effects of Nitrous Oxide
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 1995 (undefined)
Primary Completion Date
May 1996 (Actual)
Study Completion Date
May 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 examine differential acute tolerance development to effects of nitrous oxide 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, acute tolerance, subjective effects, analgesia, psychomotor, healthy volunteer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0% Nitrous oxide
Arm Type
Placebo Comparator
Arm Title
10% nitrous oxide
Arm Type
Active Comparator
Arm Title
20% nitrous oxide
Arm Type
Active Comparator
Arm Title
30% nitrous oxide
Arm Type
Active Comparator
Arm Title
40% nitrous oxide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Nitrous oxide
Primary Outcome Measure Information:
Title
Pain intensity, pain bothersomeness
Description
Subjects will inhale varying conc of nitrous oxide for 120 min with cold immersion of forearm at 25, 70, and 115 min and 40 min after inhalation. Pain intensity and bothersomeness will be assessed at each immersion.
Time Frame
25, 70, & 115 min of inhalation and 40 min post
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
8761985
Citation
Zacny JP, Cho AM, Coalson DW, Rupani G, Young CJ, Klafta JM, Klock PA, Apfelbaum JL. Differential acute tolerance development to effects of nitrous oxide in humans. Neurosci Lett. 1996 May 10;209(2):73-6. doi: 10.1016/0304-3940(96)12626-4.
Results Reference
background
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Differential Acute Tolerance Development to Effects of Nitrous Oxide - 7
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