NCT00000259

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. Comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To examine sevoflurane versus isoflurane inhalation at subanesthetic concentrations on mood, pain, and psychomotor performance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 1996

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1996

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 1997

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 1997

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 20, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 1999

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

1.3 years

First QC Date

September 20, 1999

Last Update Submit

May 26, 2015

Conditions

Keywords

sevofluranenitrous oxidesubjective effectshealthy volunteer

Outcome Measures

Primary Outcomes (3)

  • Pain intensity

    Subjects underwent a 3 min cold immersion test at 30 min of inhalation and then provided response to pain intensity questionnaire

    30 min of inhalation

  • Psychomotor performance

    Subjects underwent psychomotor testing at baseline, during inhalation, and during recovery post inhalation

    Baseline, 5 min of inhalation; 5, 30, 60 minutes recovery

  • Cognitive performance

    Subject underwent memory, sedation, visual analog, and drug effects testing

    Baseline, every 5 min during inhalation, 5, 30, & 60 min during recovery

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Subject inhales no drug (100% oxygen)

Other: Placebo

0.3% sevoflurane

ACTIVE COMPARATOR
Drug: 0.3 % Sevoflurane

0.6% sevoflurane

ACTIVE COMPARATOR
Drug: 0.6% Sevoflurane

15% Nitrous oxide

ACTIVE COMPARATOR
Drug: 15 % Nitrous oxide

30% Nitrous oxide

ACTIVE COMPARATOR
Drug: 30% Nitrous oxide

Interventions

15% Nitrous oxide
0.3% sevoflurane
30% Nitrous oxide
0.6% sevoflurane
PlaceboOTHER
Placebo

Eligibility Criteria

Age21 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
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Sponsors & Collaborators

Study Sites (1)

University of Chicago, Anesthesia & Critical Care

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • Anesthesiology. 1997 (in press).

    BACKGROUND

MeSH Terms

Conditions

Opioid-Related DisordersSubstance-Related Disorders

Interventions

Nitrous OxideSevoflurane

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Nitrogen OxidesGasesInorganic ChemicalsNitrogen CompoundsOxidesOxygen CompoundsMethyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • James Zacny, Ph.D.

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

August 1, 1996

Primary Completion

November 1, 1997

Study Completion

November 1, 1997

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations