Effects of Combined Alcohol and Nitrous Oxide Intake - 15

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00000263
First received: September 20, 1999
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to determine the effects of combined alcohol and nitrous oxide intake on mood, psychomotor performance, and the pain response in healthy volunteers.


Condition Intervention
Opioid-Related Disorders
Substance-Related Disorders
Drug: 30% Nitrous oxide
Other: 0.25 g/Kg ethanol
Other: 0.5 g/KG ethanol
Other: 0 g/Kg ethanol

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Official Title: Effects of Combined Alcohol and Nitrous Oxide Intake

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Pain intensity, pain bothersomeness [ Time Frame: Post inhalation ] [ Designated as safety issue: No ]
  • Mood [ Time Frame: Post inhalation ] [ Designated as safety issue: No ]
  • Psychomotor performance [ Time Frame: Post inhalation ] [ Designated as safety issue: No ]
  • Cognitive performance [ Time Frame: Post inhalation ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: January 1997
Study Completion Date: October 1998
Primary Completion Date: October 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 0 g/Kg ethanol +/- 30% nitrous oxide Drug: 30% Nitrous oxide Other: 0 g/Kg ethanol
Active Comparator: 0.25 g/Kg ethanol +/- 30% nitrous oxide Drug: 30% Nitrous oxide Other: 0.25 g/Kg ethanol
Active Comparator: 0.5 g/Kg ethanol +/- 30% nitrous oxide Drug: 30% Nitrous oxide Other: 0.5 g/KG ethanol

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Please contact site for information.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000263

Locations
United States, Illinois
University of Chicago, Anesthesia & Critical Care
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: James Zacny, Ph.D. University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00000263     History of Changes
Other Study ID Numbers: NIDA-08391-15, R01DA008391, R01-08391-15
Study First Received: September 20, 1999
Last Updated: July 23, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Ethanol
Nitrous Oxide
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Inhalation
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on April 23, 2014