Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide - 3

Phase 2

Completed

• Conditions: Opioid-Related Disorders; Substance-Related Disorders
• Interventions: Other: 100% oxygen; Drug: 0.4% isoflurane; Drug: 30% N2O; Drug: 0.2% isoflurane

• Registration Number: NCT00000251
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1994-04
• Primary Completion: 1996-01
• Study Completion: 1996-01
• Study First Submitted: 1999-09-20
• Study First Submitted QC: 1999-09-20
• Study First Posted: 1999-09-21
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	100% oxygen	Subjects inhale 100% oxygen
0.4% isoflurane	0.4% isoflurane	Subjects inhale 0.4% isoflurane
0.2% isoflurane + 30% N2O	30% N2O	Subjects will inhale a combination of 0.2% isoflurane and 30% N2O
0.2% isoflurane + 30% N2O	0.2% isoflurane	Subjects will inhale a combination of 0.2% isoflurane and 30% N2O
0.4% isoflurane + 30% N2O	30% N2O	Subjects will inhale a combination of 0.4% isoflurane and 30% N2O
0.4% isoflurane + 30% N2O	0.4% isoflurane	Subjects will inhale a combination of 0.4% isoflurane and 30% N2O
30% N2O	30% N2O	Subjects inhale 30% N2O
0.2% isoflurane	0.2% isoflurane	Subjects inhale 0.2% isoflurane

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Chicago, Anesthesia & Critical Care; 🇺🇸 Chicago, Illinois, United States