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

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00000264
First received: September 20, 1999
Last updated: May 26, 2015
Last verified: May 2015
  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

Ages Eligible for Study:   Child, Adult, Senior
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: 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  R01-08391-16 
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
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

ClinicalTrials.gov processed this record on September 23, 2016