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Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide - 3

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ClinicalTrials.gov Identifier: NCT00000251
Recruitment Status : Completed
First Posted : September 21, 1999
Last Update Posted : December 2, 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. To evaluate the acute and residual effects of subanesthetic concentrations of isoflurane/nitrous oxide combinations in healthy volunteers.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Substance-Related Disorders Drug: 30% N2O Drug: 0.2% isoflurane Drug: 0.4% isoflurane Other: 100% oxygen Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide
Study Start Date : April 1994
Actual Primary Completion Date : January 1996
Actual Study Completion Date : January 1996

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U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Subjects inhale 100% oxygen
Other: 100% oxygen
Placebo
Active Comparator: 30% N2O
Subjects inhale 30% N2O
Drug: 30% N2O
Active Comparator: 0.2% isoflurane
Subjects inhale 0.2% isoflurane
Drug: 0.2% isoflurane
Active Comparator: 0.4% isoflurane
Subjects inhale 0.4% isoflurane
Drug: 0.4% isoflurane
Active Comparator: 0.2% isoflurane + 30% N2O
Subjects will inhale a combination of 0.2% isoflurane and 30% N2O
Drug: 30% N2O Drug: 0.2% isoflurane
Active Comparator: 0.4% isoflurane + 30% N2O
Subjects will inhale a combination of 0.4% isoflurane and 30% N2O
Drug: 30% N2O Drug: 0.4% isoflurane



Primary Outcome Measures :
  1. Logical reasoning test [ Time Frame: 15 & 30 min inhalation and 5, 30, & 60 min post inhalation ]
  2. Free recall memory test [ Time Frame: 15 & 30 min inhalation and 5, 30, & 60 min post inhalation ]
  3. Auditory reaction time [ Time Frame: 15 & 30 min inhalation and 5,30 & 60 min post inhalation ]
  4. Digit symbol substitution test [ Time Frame: 2,15 & 30 min inhalation and 5,30 & 60 min post inhalation ]


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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.

Information from the National Library of Medicine

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): NCT00000251


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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00000251     History of Changes
Other Study ID Numbers: NIDA-08391-3
R01DA008391 ( U.S. NIH Grant/Contract )
R01-08391-3
First Posted: September 21, 1999    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015

Keywords provided by University of Chicago:
nitrous oxide
isoflurane
subjective effects
psychomotor
healthy volunteer
drug interaction

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