Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide - 3

Substance-Related Disorders Clinical Trial

Official title:

Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000251
• Other study ID #: NIDA-08391-3
• Secondary ID: R01DA008391R01-0
• Status: Completed
• Phase: Phase 2
• First received: September 20, 1999
• Last updated: November 30, 2015
• Start date: April 1994
• Est. completion date: January 1996

Study information

• Verified date: November 2015
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 1996
• Est. primary completion date: January 1996
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 32 Years
• Eligibility: Please contact site for information.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

Drug:
• 30% N2O

• 0.2% isoflurane

• 0.4% isoflurane

Other:
• 100% oxygen
Placebo

Locations

Country	Name	City	State
United States	University of Chicago, Anesthesia & Critical Care	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Zacny JP, Yajnik S, Lichtor JL, Klafta JM, Young CJ, Thapar P, Rupani G, Coalson DW, Apfelbaum JL. The acute and residual effects of subanesthetic concentrations of isoflurane/nitrous oxide combinations on cognitive and psychomotor performance in healthy volunteers. Anesth Analg. 1996 Jan;82(1):153-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Logical reasoning test		15 & 30 min inhalation and 5, 30, & 60 min post inhalation	No
Primary	Free recall memory test		15 & 30 min inhalation and 5, 30, & 60 min post inhalation	No
Primary	Auditory reaction time		15 & 30 min inhalation and 5,30 & 60 min post inhalation	No
Primary	Digit symbol substitution test		2,15 & 30 min inhalation and 5,30 & 60 min post inhalation	No