Subjective/Psychomotor/ Effects of Combined Alcohol & Nitrous Oxide - 16
May 26, 2015 updated by: University of Chicago
Subjective/Psychomotor/ Effects of Combined Alcohol & Nitrous Oxide
The purpose of this study is to examine the subjective, psychomotor, and reinforcing effects of combined alcohol and nitrous oxide intake in healthy volunteers.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8
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
- Child
- Adult
- Older 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
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: 0 g/Kg ethanol +/- 30% nitrous oxide
|
|
|
Active Comparator: 0.35 g/Kg ethanol +/- 30% nitrous oxide
|
|
|
Active Comparator: 0.7 g/Kg ethanol +/- 30% nitrous oxide
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mood
Time Frame: Baseline and post inhalation
|
Baseline and post inhalation
|
|
Psychomotor performance
Time Frame: Baseline and post inhalation
|
Baseline and post inhalation
|
|
Cognitive performance
Time Frame: Baseline and post inhalation
|
Baseline and post inhalation
|
|
Choice of nitrous oxide vs placebo
Time Frame: after each ethanol session
|
after each ethanol session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
September 1, 1997
Primary Completion (Actual)
October 1, 1999
Study Completion (Actual)
October 1, 1999
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 27, 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
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Anesthetics, Inhalation
- Ethanol
- Nitrous Oxide
Other Study ID Numbers
- NIDA-08391-16
- R01DA008391 (U.S. NIH Grant/Contract)
- R01-08391-16
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.