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Effects of Alcohol History on Effects of Nitrous Oxide - 9

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ClinicalTrials.gov Identifier: NCT00000257
Recruitment Status : Completed
First Posted : September 21, 1999
Last Update Posted : May 28, 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 28, 2015
Study Start Date  ICMJE September 1995
Actual Primary Completion Date April 1997   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2013)
Choice of nitrous oxide vs placebo [ Time Frame: After 30 min inhalation each of N2O and placebo ]
Two subject groups (light drinkers vs moderate drinkers) were asked to inhale a given conc of N2O and inhale a placebo, then choose for a third inhalation. The subject & the technician administering the inhalant were blinded. Testing was done at each dose.
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Mood
  • Psychomotor performance
  • Choice of nitrous oxide vs placebo
Change History Complete list of historical versions of study NCT00000257 on ClinicalTrials.gov Archive Site
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 Nitrous Oxide - 9
Official Title  ICMJE Effects of Alcohol History on Effects of Nitrous Oxide
Brief Summary The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. Comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To determine effects of alcohol history on the reinforcing, subjective and psychomotor effects of nitrous oxide in healthy volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE
  • Alcohol-Related Disorders
  • Opioid-Related Disorders
  • Substance-Related Disorders
Intervention  ICMJE
  • Drug: 0% N2O and 10% N2O
  • Drug: 0% N2O and 20% N2O
  • Drug: 0% N2O and 30% N2O
  • Drug: 0% N2O and 40% N2O
Study Arms  ICMJE
  • Active Comparator: Light drinkers
    Interventions:
    • Drug: 0% N2O and 10% N2O
    • Drug: 0% N2O and 20% N2O
    • Drug: 0% N2O and 30% N2O
    • Drug: 0% N2O and 40% N2O
  • Active Comparator: Moderate drinkers
    Interventions:
    • Drug: 0% N2O and 10% N2O
    • Drug: 0% N2O and 20% N2O
    • Drug: 0% N2O and 30% N2O
    • Drug: 0% N2O and 40% N2O
Publications * Cho AM, Coalson DW, Klock PA, Klafta JM, Marks S, Toledano AY, Apfelbaum JL, Zacny JP. The effects of alcohol history on the reinforcing, subjective and psychomotor effects of nitrous oxide in healthy volunteers. Drug Alcohol Depend. 1997 Apr 14;45(1-2):63-70.

*   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)
19
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
0
Actual Study Completion Date  ICMJE April 1997
Actual Primary Completion Date April 1997   (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 21 Years to 37 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT00000257
Other Study ID Numbers  ICMJE NIDA-08391-9
R01DA008391 ( U.S. NIH Grant/Contract )
R01-08391-9
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