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Lack of Acute Tolerance Development to Effects of Nitrous Oxide - 4

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000252
First Posted: September 21, 1999
Last Update Posted: May 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Chicago
  Purpose
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 lack of acute tolerance development to the subjective, cognitive, and psychomotor effects of nitrous oxide in healthy volunteers.

Condition Intervention Phase
Opioid-Related Disorders Substance-Related Disorders Drug: 0% N2O Drug: 10% N2O Drug: 20% N2O Drug: 30% N2O Drug: 40% N2O Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Lack of Acute Tolerance Development to Effects of Nitrous Oxide

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Psychomotor performance [ Time Frame: During inhalation ]
    Subjects will undergo psychomotor testing during 120 min inhalation session of each intervention

  • Cognitive performance [ Time Frame: During inhalation ]
    Subjects will under cognitive testing during 120 minute inhalation session of each intervention


Enrollment: 11
Study Start Date: June 1994
Study Completion Date: June 1996
Primary Completion Date: June 1996 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: 0% N2O
Subjects will inhale 0% N2O
Drug: 0% N2O
Active Comparator: 10% N2O
Subjects will inhale 10% N2O
Drug: 10% N2O
Active Comparator: 20% N2O
Subjects will inhale 20% N2O
Drug: 20% N2O
Active Comparator: 30% N2O
Subjects will inhale 30% N2O
Drug: 30% N2O
Active Comparator: 40% N2O
Subjects will inhale 40% N2O
Drug: 40% N2O

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Please contact site for information.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00000252


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
  More Information

Publications:
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00000252     History of Changes
Other Study ID Numbers: NIDA-08391-4
R01DA008391 ( U.S. NIH Grant/Contract )
R01-08391-4
First Submitted: September 20, 1999
First Posted: September 21, 1999
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by University of Chicago:
nitrous oxide
acute tolerance
subjective effects
psychomotor
analgesia
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