NCT00000261

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 1997

Shorter than P25 for phase_2

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

November 1, 1997

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 1998

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 1998

Completed
12 months 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 27, 2015

Status Verified

May 1, 2015

Enrollment Period

11 months

First QC Date

September 20, 1999

Last Update Submit

May 26, 2015

Conditions

Alcohol-Related DisordersOpioid-Related DisordersSubstance-Related Disorders

Keywords

nitrous oxidesevofluraneethanolsubjective effectshealthy volunteer

Outcome Measures

Primary Outcomes (3)

  • Mood

    Baseline, inhalation, recovery

  • Psychomotor performance

    Baseline, inhalation, recovery

  • Choice of drug vs placebo

    After placebo and drug in each session

Study Arms (1)

Moderate drinking adults

EXPERIMENTAL
Drug: 30% Nitrous oxideOther: PlaceboDrug: 0.2% sevofluraneDrug: 0.4% sevofluraneDrug: 0.6% sevoflurane

Interventions

30% Nitrous oxideDRUG
Moderate drinking adults
PlaceboOTHER

No drug (100% oxygen)

Moderate drinking adults
0.2% sevofluraneDRUG
Moderate drinking adults
0.4% sevofluraneDRUG
Moderate drinking adults
0.6% sevofluraneDRUG
Moderate drinking adults

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Please contact site for information.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Chicago, Anesthesia & Critical Care

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Alcohol-Related DisordersOpioid-Related DisordersSubstance-Related Disorders

Interventions

Nitrous OxideSevoflurane

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersNarcotic-Related 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
phase 2
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

November 1, 1997

Primary Completion

October 1, 1998

Study Completion

October 1, 1998

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

US(1)