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

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00000252
First received: September 20, 1999
Last updated: May 26, 2015
Last verified: May 2015
  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 Blind (Subject, 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 ] [ Designated as safety issue: No ]
    Subjects will undergo psychomotor testing during 120 min inhalation session of each intervention

  • Cognitive performance [ Time Frame: During inhalation ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   21 Years to 29 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
Please contact site for information.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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  R01-08391-4 
Study First Received: September 20, 1999
Last Updated: May 26, 2015
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on August 23, 2016