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Effects of Subanesthetic Concentrations of Nitrous Oxide - 1

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ClinicalTrials.gov Identifier: NCT00000249
Recruitment Status : Completed
First Posted : September 21, 1999
Last Update Posted : May 28, 2015
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Substance-Related Disorders Drug: 20% N2O Drug: 30% N2O Drug: 40% N2O Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Subanesthetic Concentrations of Nitrous Oxide
Study Start Date : September 1993
Actual Primary Completion Date : June 1995
Actual Study Completion Date : June 1995

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control
Subject inhaled 0% N2O for 40 minutes with cold immersion at 10 and 30 minutes
Active Comparator: 20% N2O
Subject inhaled 20% N2O for 40 minutes with cold immersion at 10 & 30 minutes
Drug: 20% N2O
20% inhaled N2O
Active Comparator: 30% N2O
Subject inhaled 30% N2O for 40 minutes with cold immersion at 10 and 30 minutes
Drug: 30% N2O
30% inhaled N2O
Active Comparator: 40% N2O
Subject inhaled 40% N2O for 40 minutes with cold immersion at 10 and 30 minutes
Drug: 40% N2O
40% inhaled N2O



Primary Outcome Measures :
  1. Pain intensity [ Time Frame: during cold test at 10 min & 30 min of inhalation ]
    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



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Ages Eligible for Study:   21 Years to 37 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Please contact site for information.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000249


Locations
United States, Illinois
University of Chicago, Anesthesia & Critical Care
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: James Zacny, Ph.D. University of Chicago

Publications:
Pharmocol Biochem and Behavior 1995, 51( 2): 323-329

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00000249     History of Changes
Other Study ID Numbers: NIDA-08391-1
R01DA008391 ( U.S. NIH Grant/Contract )
R01-08391-1
First Posted: September 21, 1999    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by University of Chicago:
nitrous oxide
subjective effects
healthy volunteer

Additional relevant MeSH terms:
Disease
Substance-Related Disorders
Opioid-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents