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

This study has been completed.

Sponsor:

Collaborator:

National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

University of Chicago

ClinicalTrials.gov Identifier:

NCT00000261

First received: September 20, 1999

Last updated: May 26, 2015

Last verified: May 2015

History of Changes

Purpose

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	Intervention	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 Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver)
Official Title:	Effects of Alcohol History on Effects of Sevoflurane and Nitrous Oxide

Resource links provided by NLM:

Drug Information available for: Nitrous oxide Sevoflurane

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

Mood [ Time Frame: Baseline, inhalation, recovery ] [ Designated as safety issue: No ]
Psychomotor performance [ Time Frame: Baseline, inhalation, recovery ] [ Designated as safety issue: No ]
Choice of drug vs placebo [ Time Frame: After placebo and drug in each session ]


Enrollment:	14
Study Start Date:	November 1997
Study Completion Date:	October 1998
Primary Completion Date:	October 1998 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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: 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


Responsible Party:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00000261 History of Changes
Other Study ID Numbers:	NIDA-08391-13 R01DA008391 R01-08391-13
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 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

ClinicalTrials.gov processed this record on September 27, 2016

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