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Effects of Nitrous Oxide: A Dose-Response Analysis - 5

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ClinicalTrials.gov Identifier: NCT00000253
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 the subjective, psychomotor, and reinforcing effects of nitrous oxide in healthy volunteers. This is a dose-response analysis.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Substance-Related Disorders Drug: 10% N2O Drug: 20% N2O Drug: 30% N2O Drug: 40% N2O Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: Effects of Nitrous Oxide: A Dose-Response Analysis
Study Start Date : November 1994
Actual Primary Completion Date : March 1996
Actual Study Completion Date : March 1996

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Placebo + 10% N2O
0% N2O inhaled during psychomotor testing, 10% N2O inhaled during psycho motor testing, then subject's choice of the 2.
Drug: 10% N2O
Active Comparator: Placebo + 20% N2O
Placebo inhaled during psychomotor testing, 20% N2O inhaled during psychomotor testing, then subject's choice of the 2.
Drug: 20% N2O
Active Comparator: Placebo + 30% N2O
Placebo inhaled during psychomotor testing, 30% N2O inhaled during psychomotor testing, then subject's choice of the 2.
Drug: 30% N2O
Active Comparator: Placebo + 40% N2O
Placebo inhaled during psychomotor testing, 40% N2O inhaled during psychomotor testing, then subject's choice of the 2.
Drug: 40% N2O



Primary Outcome Measures :
  1. Choice of N2O vs. placebo [ Time Frame: After each pair of sample tests ]
    Subjects underwent 4 sessions consisting of 2 sample tests (inhaling placebo and inhaling varying doses of N2O), then choosing which inhalant they wanted for a choice test. The subject & the technician administering the inhalant were blinded. During each intervention and each session, subjects underwent psychomotor testing.



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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): NCT00000253


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:
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00000253     History of Changes
Other Study ID Numbers: NIDA-08391-5
R01DA008391 ( U.S. NIH Grant/Contract )
R01-08391-5
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
inhalant
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