Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide - 3

November 30, 2015 updated by: University of Chicago

Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

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

  • United States
    • 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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Logical reasoning test
Time Frame: 15 & 30 min inhalation and 5, 30, & 60 min post inhalation
15 & 30 min inhalation and 5, 30, & 60 min post inhalation
Free recall memory test
Time Frame: 15 & 30 min inhalation and 5, 30, & 60 min post inhalation
15 & 30 min inhalation and 5, 30, & 60 min post inhalation
Auditory reaction time
Time Frame: 15 & 30 min inhalation and 5,30 & 60 min post inhalation
15 & 30 min inhalation and 5,30 & 60 min post inhalation
Digit symbol substitution test
Time Frame: 2,15 & 30 min inhalation and 5,30 & 60 min post inhalation
2,15 & 30 min inhalation and 5,30 & 60 min post inhalation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

National Institute on Drug Abuse (NIDA)

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.

General Publications

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, 1994

Primary Completion (Actual)

January 1, 1996

Study Completion (Actual)

January 1, 1996

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)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-08391-3
  • R01DA008391 (U.S. NIH Grant/Contract)
  • R01-08391-3

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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