Subjective/Psychomotor/ Effects of Combined Alcohol & Nitrous Oxide - 16

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00000264
First received: September 20, 1999
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to examine the subjective, psychomotor, and reinforcing effects of combined alcohol and nitrous oxide intake in healthy volunteers.


Condition Intervention
Opioid-Related Disorders
Substance-Related Disorders
Drug: 30% Nitrous oxide
Other: 0.35 g/Kg ethanol
Other: 0.7 g/Kg ethanol
Other: 0 g/Kg ethanol

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Official Title: Subjective/Psychomotor/ Effects of Combined Alcohol & Nitrous Oxide

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Mood [ Time Frame: Baseline and post inhalation ] [ Designated as safety issue: No ]
  • Psychomotor performance [ Time Frame: Baseline and post inhalation ] [ Designated as safety issue: No ]
  • Cognitive performance [ Time Frame: Baseline and post inhalation ] [ Designated as safety issue: No ]
  • Choice of nitrous oxide vs placebo [ Time Frame: after each ethanol session ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: September 1997
Study Completion Date: October 1999
Primary Completion Date: October 1999 (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: 0.35 g/Kg ethanol +/- 30% nitrous oxide Drug: 30% Nitrous oxide Other: 0.35 g/Kg ethanol
Active Comparator: 0.7 g/Kg ethanol +/- 30% nitrous oxide Drug: 30% Nitrous oxide Other: 0.7 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: NCT00000264

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: NCT00000264     History of Changes
Other Study ID Numbers: NIDA-08391-16, R01DA008391, R01-08391-16
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 21, 2014