ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Alcohol History on Effects of Nitrous Oxide - 9

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: 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

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Alcohol-Related Disorders Opioid-Related Disorders Substance-Related Disorders Drug: 0% N2O and 10% N2O Drug: 0% N2O and 20% N2O Drug: 0% N2O and 30% N2O Drug: 0% N2O and 40% N2O Not Applicable

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: Effects of Alcohol History on Effects of Nitrous Oxide
Study Start Date : September 1995
Actual Primary Completion Date : April 1997
Actual Study Completion Date : April 1997

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Light drinkers 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 Drug: 0% N2O and 10% N2O Drug: 0% N2O and 20% N2O Drug: 0% N2O and 30% N2O Drug: 0% N2O and 40% N2O


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 37 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Please contact site for information.
Contacts and Locations
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT00000257


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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00000257     History of Changes
Other Study ID Numbers: NIDA-08391-9
R01DA008391 ( U.S. NIH Grant/Contract )
R01-08391-9
First Posted: September 21, 1999    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

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

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