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Role of Instructions in Nitrous Oxide Effects and Choice - 10

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ClinicalTrials.gov Identifier: NCT00000258
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

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 evaluate the role of instructions in nitrous oxide subjective effects and choice.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Substance-Related Disorders Drug: Nitrous oxide 10% & placebo Drug: Nitrous oxide 20% & placebo Drug: Nitrous oxide 30% & placebo Drug: Nitrous oxide 40% and placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: Role of Instructions in Nitrous Oxide Effects and Choice
Study Start Date : April 1996
Actual Primary Completion Date : November 1997
Actual Study Completion Date : November 1997

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Informed group
Group inhaled placebo and varying doses of nitrous oxide in pairs then chose which they wanted for a third inhalation.
Drug: Nitrous oxide 10% & placebo
Drug: Nitrous oxide 20% & placebo
Drug: Nitrous oxide 30% & placebo
Drug: Nitrous oxide 40% and placebo
Active Comparator: Non-informed Group
Group and technician were blinded as to which gas they were inhaling in pairs with third inhalation subject's choice.
Drug: Nitrous oxide 10% & placebo
Drug: Nitrous oxide 20% & placebo
Drug: Nitrous oxide 30% & placebo
Drug: Nitrous oxide 40% and placebo



Primary Outcome Measures :
  1. Choice of nitrous oxide vs placebo [ Time Frame: After 30 min inhalation of each ]
    Subjects inhaled placebo and varying per centages of nitrous oxide in sampling pair, then chose for third inhalation. One group was told which of the gases they were inhaling during sampling and one group as well as the technician administering the inhalant was blinded. Psychomotor tests were done at each dose.



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Ages Eligible for Study:   21 Years to 32 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Please contact site for information.

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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): NCT00000258


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

Publications:
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00000258     History of Changes
Other Study ID Numbers: NIDA-08391-10
R01DA008391 ( U.S. NIH Grant/Contract )
R01-08391-10
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
instruction
subjective effects
reinforcer
healthy volunteer

Additional relevant MeSH terms:
Disease
Substance-Related Disorders
Opioid-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