- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000258
Role of Instructions in Nitrous Oxide Effects and Choice - 10
May 26, 2015 updated by: University of Chicago
Role of Instructions in Nitrous Oxide Effects and Choice
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.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- University of Chicago, Anesthesia & Critical Care
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 32 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Please contact site for information.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
After 30 min inhalation of each
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 1996
Primary Completion (Actual)
November 1, 1997
Study Completion (Actual)
November 1, 1997
Study Registration Dates
First Submitted
September 20, 1999
First Submitted That Met QC Criteria
September 20, 1999
First Posted (Estimate)
September 21, 1999
Study Record Updates
Last Update Posted (Estimate)
May 28, 2015
Last Update Submitted That Met QC Criteria
May 26, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Pathologic Processes
- Narcotic-Related Disorders
- Substance-Related Disorders
- Disease
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Anesthetics, Inhalation
- Nitrous Oxide
Other Study ID Numbers
- NIDA-08391-10
- R01DA008391 (U.S. NIH Grant/Contract)
- R01-08391-10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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