Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide - 3

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00000251
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. To evaluate the acute and residual effects of subanesthetic concentrations of isoflurane/nitrous oxide combinations in healthy volunteers.


Condition Intervention Phase
Opioid-Related Disorders
Substance-Related Disorders
Drug: 30% N2O
Drug: 0.2% isoflurane
Drug: 0.4% isoflurane
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Logical reasoning test [ Time Frame: 15 & 30 min inhalation and 5, 30, & 60 min post inhalation ] [ Designated as safety issue: No ]
  • Free recall memory test [ Time Frame: 15 & 30 min inhalation and 5, 30, & 60 min post inhalation ] [ Designated as safety issue: No ]
  • Auditory reaction time [ Time Frame: 15 & 30 min inhalation and 5,30 & 60 min post inhalation ] [ Designated as safety issue: No ]
  • Digit symbol substitution test [ Time Frame: 2,15 & 30 min inhalation and 5,30 & 60 min post inhalation ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: April 1994
Study Completion Date: January 1996
Primary Completion Date: January 1996 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Subjects inhale 100% oxygen
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

  Eligibility

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

Please contact site for information.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000251

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: NCT00000251     History of Changes
Other Study ID Numbers: NIDA-08391-3, R01DA008391, R01-08391-3
Study First Received: September 20, 1999
Last Updated: July 23, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Isoflurane
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 April 17, 2014