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NCT00000254 Clinical Trial

Isoflurane at Subanesthetic Concentrations - 6

Substance-Related Disorders Clinical Trial

Official title:
Isoflurane at Subanesthetic Concentrations

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000254
Other study ID # NIDA-08391-6
Secondary ID R01DA008391R01-0
Status Completed
Phase Phase 2
First received September 20, 1999
Last updated May 26, 2015
Start date January 1995
Est. completion date September 1995

Study information
Verified date May 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 test the hypothesis that isoflurane at subanesthetic concentrations does not reduce cold-water immersion pain in healthy volunteers.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date September 1995
Est. primary completion date September 1995
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 21 Years to 34 Years
Eligibility Please contact site for information.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• 40% Nitrous oxide
Used as pain assay positive control
Other:
• Sham comparator
0% isoflurane in oxygen
Drug:
• 0.2% isoflurane

• 0.4% isoflurane

• 0.6% isoflurane

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)

Anesthesiology, 1995, 83: A287

Outcome
Type Measure Description Time frame Safety issue
Primary Pain response Effects of inhaled isoflurane on pain from immersion of subject's arm in ice cold water. Nitrous oxide (40%) was used as a positive control to confirm sensitivity of the pain assay. Post inhalation No
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