Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide - 3

NCT ID: NCT00000251

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-04-30

Study Completion Date

1996-01-31

Brief Summary

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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

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Conditions

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Opioid-Related Disorders Substance-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

Subjects inhale 100% oxygen

Group Type PLACEBO_COMPARATOR

100% oxygen

Intervention Type OTHER

Placebo

30% N2O

Subjects inhale 30% N2O

Group Type ACTIVE_COMPARATOR

30% N2O

Intervention Type DRUG

0.2% isoflurane

Subjects inhale 0.2% isoflurane

Group Type ACTIVE_COMPARATOR

0.2% isoflurane

Intervention Type DRUG

0.4% isoflurane

Subjects inhale 0.4% isoflurane

Group Type ACTIVE_COMPARATOR

0.4% isoflurane

Intervention Type DRUG

0.2% isoflurane + 30% N2O

Subjects will inhale a combination of 0.2% isoflurane and 30% N2O

Group Type ACTIVE_COMPARATOR

30% N2O

Intervention Type DRUG

0.2% isoflurane

Intervention Type DRUG

0.4% isoflurane + 30% N2O

Subjects will inhale a combination of 0.4% isoflurane and 30% N2O

Group Type ACTIVE_COMPARATOR

30% N2O

Intervention Type DRUG

0.4% isoflurane

Intervention Type DRUG

Interventions

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30% N2O

Intervention Type DRUG

0.2% isoflurane

Intervention Type DRUG

0.4% isoflurane

Intervention Type DRUG

100% oxygen

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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Minimum Eligible Age

21 Years

Maximum Eligible Age

32 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Zacny, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago, Anesthesia & Critical Care

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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. doi: 10.1097/00000539-199601000-00028.

Reference Type BACKGROUND
PMID: 8712393 (View on PubMed)

Whelan J, Hackshaw A, McTiernan A, Grimer R, Spooner D, Bate J, Ranft A, Paulussen M, Juergens H, Craft A, Lewis I. Survival is influenced by approaches to local treatment of Ewing sarcoma within an international randomised controlled trial: analysis of EICESS-92. Clin Sarcoma Res. 2018 Mar 30;8:6. doi: 10.1186/s13569-018-0093-y. eCollection 2018.

Reference Type DERIVED
PMID: 29610659 (View on PubMed)

Other Identifiers

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R01DA008391

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01-08391-3

Identifier Type: -

Identifier Source: secondary_id

NIDA-08391-3

Identifier Type: -

Identifier Source: org_study_id