Back to resultsCold Water Immersion Modulates Reinforcing Effects of Nitrous Oxide - 2
Primary Purpose
Opioid-Related Disorders, Substance-Related Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
0% N2O
40% N2O
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-Related Disorders focused on measuring nitrous oxide, choice, subjective effects, pain, analgesia, reinforcer, 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 Type
Active Comparator
Active Comparator
Arm Label
Lukewarm water
Ice cold water
Arm Description
Subjects will immerse forearm in lukewarm water while inhaling 0% and 40% N2O in 2 sampling trials, then choose between intervntions for one choice trial
Subjects will immerse forearm in ice cold water while inhaling 0% and 40% N2O in 2 sampling trials, then choose between intervntions for one choice trial
Outcomes
Primary Outcome Measures
Subject's choice of intervention
Secondary Outcome Measures
Full Information
NCT ID
NCT00000250
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
NCT00000250
Brief Title
Cold Water Immersion Modulates Reinforcing Effects of Nitrous Oxide - 2
Official Title
Cold Water Immersion Modulates Reinforcing Effects of Nitrous Oxide
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 1993 (undefined)
Primary Completion Date
May 1995 (Actual)
Study Completion Date
May 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 evaluate: cold water immersion modulates the reinforcing effects of nitrous oxide 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, choice, subjective effects, pain, analgesia, reinforcer, healthy volunteer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lukewarm water
Arm Type
Active Comparator
Arm Description
Subjects will immerse forearm in lukewarm water while inhaling 0% and 40% N2O in 2 sampling trials, then choose between intervntions for one choice trial
Arm Title
Ice cold water
Arm Type
Active Comparator
Arm Description
Subjects will immerse forearm in ice cold water while inhaling 0% and 40% N2O in 2 sampling trials, then choose between intervntions for one choice trial
Intervention Type
Drug
Intervention Name(s)
0% N2O
Intervention Description
Subjects will inhale 100% oxygen with no N2O for 25 min then immerse forearm in warm water and cold water
Intervention Type
Drug
Intervention Name(s)
40% N2O
Intervention Description
Subjects will inhale 40% N2O then immerse forearm in warm water and cold water
Primary Outcome Measure Information:
Title
Subject's choice of intervention
Time Frame
After sampling trials
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:
Citation
Experimentall Clinical Psycopharmacoly 1995, 3(2):148-155
Results Reference
background
Learn more about this trial
Cold Water Immersion Modulates Reinforcing Effects of Nitrous Oxide - 2
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