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

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.
 
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

Tracking Information
First Submitted Date  ICMJE September 20, 1999
First Posted Date  ICMJE September 21, 1999
Last Update Posted Date May 27, 2015
Study Start Date  ICMJE November 1997
Actual Primary Completion Date October 1998   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2013)
  • Mood [ Time Frame: Baseline, inhalation, recovery ]
  • Psychomotor performance [ Time Frame: Baseline, inhalation, recovery ]
  • Choice of drug vs placebo [ Time Frame: After placebo and drug in each session ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Choice of drug vs placebo
  • Mood
  • Psychomotor performance
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Alcohol History on Effects of Sevoflurane and Nitrous Oxide - 13
Official Title  ICMJE Effects of Alcohol History on Effects of Sevoflurane and Nitrous Oxide
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Condition  ICMJE
  • Alcohol-Related Disorders
  • Opioid-Related Disorders
  • Substance-Related Disorders
Intervention  ICMJE
  • Drug: 30% Nitrous oxide
  • Other: Placebo
    No drug (100% oxygen)
  • Drug: 0.2% sevoflurane
  • Drug: 0.4% sevoflurane
  • Drug: 0.6% sevoflurane
Study Arms  ICMJE Experimental: Moderate drinking adults
Interventions:
  • Drug: 30% Nitrous oxide
  • Other: Placebo
  • Drug: 0.2% sevoflurane
  • Drug: 0.4% sevoflurane
  • Drug: 0.6% sevoflurane
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2013)
14
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
0
Actual Study Completion Date  ICMJE October 1998
Actual Primary Completion Date October 1998   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE Please contact site for information.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000261
Other Study ID Numbers  ICMJE NIDA-08391-13
R01DA008391 ( U.S. NIH Grant/Contract )
R01-08391-13
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: James Zacny, Ph.D. University of Chicago
PRS Account University of Chicago
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP