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Effects of Alcohol History on Effects of Sevoflurane and Nitrous Oxide - 13

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ClinicalTrials.gov Identifier: NCT00000261
Recruitment Status : Completed
First Posted : September 21, 1999
Last Update Posted : May 27, 2015
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Chicago

Study Description
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Brief Summary:
The purpose of this study is to evaluate the effects of alcohol history on the subjective and reinforcing effects of sevoflurane and nitrous oxide in healthy volunteers. All subjects underwent psychomotor testing during 4 sessions of placebo, drug/placebo, and choice of intervention.

Condition or disease Intervention/treatment Phase
Alcohol-Related Disorders Opioid-Related Disorders Substance-Related Disorders Drug: 30% Nitrous oxide Other: Placebo Drug: 0.2% sevoflurane Drug: 0.4% sevoflurane Drug: 0.6% sevoflurane Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Official Title: Effects of Alcohol History on Effects of Sevoflurane and Nitrous Oxide
Study Start Date : November 1997
Actual Primary Completion Date : October 1998
Actual Study Completion Date : October 1998

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Moderate drinking adults Drug: 30% Nitrous oxide
Other: Placebo
No drug (100% oxygen)

Drug: 0.2% sevoflurane
Drug: 0.4% sevoflurane
Drug: 0.6% sevoflurane


Outcome Measures
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Primary Outcome Measures :
  1. Mood [ Time Frame: Baseline, inhalation, recovery ]
  2. Psychomotor performance [ Time Frame: Baseline, inhalation, recovery ]
  3. Choice of drug vs placebo [ Time Frame: After placebo and drug in each session ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
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Contacts and Locations
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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): NCT00000261


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
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00000261     History of Changes
Other Study ID Numbers: NIDA-08391-13
R01DA008391 ( U.S. NIH Grant/Contract )
R01-08391-13
First Posted: September 21, 1999    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

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

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