Role of Instructions in Nitrous Oxide Effects and Choice - 10

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00000258
First received: September 20, 1999
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Role of Instructions in Nitrous Oxide Effects and Choice

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Choice of nitrous oxide vs placebo [ Time Frame: After 30 min inhalation of each ] [ Designated as safety issue: No ]
    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.


Enrollment: 22
Study Start Date: April 1996
Study Completion Date: November 1997
Primary Completion Date: November 1997 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 32 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00000258

Locations
United States, Illinois
University of Chicago, Anesthesia & Critical Care
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: James Zacny, Ph.D. University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00000258     History of Changes
Other Study ID Numbers: NIDA-08391-10, R01DA008391, R01-08391-10
Study First Received: September 20, 1999
Last Updated: July 23, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on October 19, 2014