Differential Acute Tolerance Development to Effects of Nitrous Oxide - 7

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00000255
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 differential acute tolerance development to effects of nitrous oxide in humans.

Condition Intervention Phase
Opioid-Related Disorders
Substance-Related Disorders
Drug: Nitrous oxide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Differential 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:
  • Pain intensity, pain bothersomeness [ Time Frame: 25, 70, & 115 min of inhalation and 40 min post ] [ Designated as safety issue: No ]
    Subjects will inhale varying conc of nitrous oxide for 120 min with cold immersion of forearm at 25, 70, and 115 min and 40 min after inhalation. Pain intensity and bothersomeness will be assessed at each immersion.


Enrollment: 10
Study Start Date: April 1995
Study Completion Date: May 1996
Primary Completion Date: May 1996 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 0% Nitrous oxide Drug: Nitrous oxide
Active Comparator: 10% nitrous oxide Drug: Nitrous oxide
Active Comparator: 20% nitrous oxide Drug: Nitrous oxide
Active Comparator: 30% nitrous oxide Drug: Nitrous oxide
Active Comparator: 40% nitrous oxide Drug: Nitrous oxide

  Eligibility

Ages Eligible for Study:   21 Years to 37 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
Please contact site for information.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000255

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: NCT00000255     History of Changes
Other Study ID Numbers: NIDA-08391-7  R01DA008391  R01-08391-7 
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
analgesia
psychomotor
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 25, 2016