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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000264
First Posted: September 21, 1999
Last Update Posted: May 27, 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 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 (Participant, Care Provider)
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 ]
  • Psychomotor performance [ Time Frame: Baseline and post inhalation ]
  • Cognitive performance [ Time Frame: Baseline and post inhalation ]
  • Choice of nitrous oxide vs placebo [ Time Frame: after each ethanol session ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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): NCT00000264


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

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00000264     History of Changes
Other Study ID Numbers: NIDA-08391-16
R01DA008391 ( U.S. NIH Grant/Contract )
R01-08391-16
First Submitted: September 20, 1999
First Posted: September 21, 1999
Last Update Posted: May 27, 2015
Last Verified: May 2015

Keywords provided by University of Chicago:
nitrous oxide
inhalant
ethanol
subjective effects
psychomotor effects
healthy volunteer

Additional relevant MeSH terms:
Disease
Substance-Related Disorders
Opioid-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Ethanol
Nitrous Oxide
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents