Effects of Alcohol History on Effects of Sevoflurane and Nitrous Oxide - 13

• Sponsor: University of Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT00000261
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 14
• Location: 1
• Arm: 1
• Duration (Months): 11
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effects of alcohol history on the subjective and reinforcing effects of sevoflurane and nitrous oxide in healthy volunteers. All subjects underwent psychomotor testing during 4 sessions of placebo, drug/placebo, and choice of intervention.

Condition or Disease	Intervention/Treatment	Phase
Alcohol-Related Disorders; Opioid-Related Disorders; Substance-Related Disorders	Drug: 30% Nitrous oxide; Other: Placebo; Drug: 0.2% sevoflurane; Drug: 0.4% sevoflurane; Drug: 0.6% sevoflurane	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Care Provider)
• Official Title: Effects of Alcohol History on Effects of Sevoflurane and Nitrous Oxide
• Study Start Date: Nov 1, 1997
• Actual Primary Completion Date: Oct 1, 1998
• Actual Study Completion Date: Oct 1, 1998

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Moderate drinking adults	Drug: 30% Nitrous oxide; Other: Placebo; No drug (100% oxygen); Drug: 0.2% sevoflurane; Drug: 0.4% sevoflurane; Drug: 0.6% sevoflurane

Outcome Measures

Primary Outcome Measures

1. Mood [Baseline, inhalation, recovery]

2. Psychomotor performance [Baseline, inhalation, recovery]

3. Choice of drug vs placebo [After placebo and drug in each session]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago, Anesthesia & Critical Care	Chicago	Illinois	United States	60637

Sponsors and Collaborators

• University of Chicago
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: James Zacny, Ph.D., University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT00000261
• Other Study ID Numbers: NIDA-08391-13; R01DA008391; R01-08391-13
• First Posted: Sep 21, 1999
• Last Update Posted: May 27, 2015
• Last Verified: May 1, 2015

• Keywords provided by University of Chicago: nitrous oxide; sevoflurane; ethanol; subjective effects; healthy volunteer
• Additional relevant MeSH terms: Disease; Substance-Related Disorders; Opioid-Related Disorders; Alcohol-Related Disorders; Nitrous Oxide; Sevoflurane

Study Results

No Results Posted as of May 27, 2015