Lack of Acute Tolerance Development to Effects of Nitrous Oxide - 4
3 other identifiers
interventional
11
1 country
1
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. To examine the lack of acute tolerance development to the subjective, cognitive, and psychomotor effects of nitrous oxide in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 1994
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 1994
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 1996
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 1996
CompletedFirst Submitted
Initial submission to the registry
September 20, 1999
CompletedFirst Posted
Study publicly available on registry
September 21, 1999
CompletedMay 28, 2015
May 1, 2015
2 years
September 20, 1999
May 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Psychomotor performance
Subjects will undergo psychomotor testing during 120 min inhalation session of each intervention
During inhalation
Cognitive performance
Subjects will under cognitive testing during 120 minute inhalation session of each intervention
During inhalation
Study Arms (5)
0% N2O
SHAM COMPARATORSubjects will inhale 0% N2O
10% N2O
ACTIVE COMPARATORSubjects will inhale 10% N2O
20% N2O
ACTIVE COMPARATORSubjects will inhale 20% N2O
30% N2O
ACTIVE COMPARATORSubjects will inhale 30% N2O
40% N2O
ACTIVE COMPARATORSubjects will inhale 40% N2O
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- University of Chicagolead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
University of Chicago, Anesthesia & Critical Care
Chicago, Illinois, 60637, United States
Related Publications (1)
Yajnik S, Zacny JP, Young CJ, Lichtor JL, Rupani G, Klafta JM, Coalson DW, Apfelbaum JL. Lack of acute tolerance development to the subjective, cognitive, and psychomotor effects of nitrous oxide in healthy volunteers. Pharmacol Biochem Behav. 1996 Jun;54(2):501-8. doi: 10.1016/0091-3057(95)02278-3.
PMID: 8743615BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Zacny, Ph.D.
University of Chicago
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 1999
First Posted
September 21, 1999
Study Start
June 1, 1994
Primary Completion
June 1, 1996
Study Completion
June 1, 1996
Last Updated
May 28, 2015
Record last verified: 2015-05