NCT00000254

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. To test the hypothesis that isoflurane at subanesthetic concentrations does not reduce cold-water immersion pain in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 1995

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

January 1, 1995

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 1995

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 1995

Completed
4.1 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

8 months

First QC Date

September 20, 1999

Last Update Submit

May 26, 2015

Conditions

Opioid-Related DisordersSubstance-Related Disorders

Keywords

isofluranegeneral anestheticinhalantsubjective effectshealthy volunteer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

0% isoflurane

SHAM COMPARATOR
Drug: 40% Nitrous oxideOther: Sham comparator

0.2% isoflurane

ACTIVE COMPARATOR
Drug: 40% Nitrous oxideDrug: 0.2% isoflurane

0.4% isoflurane

ACTIVE COMPARATOR
Drug: 40% Nitrous oxideDrug: 0.4% isoflurane

0.6% isoflurane

ACTIVE COMPARATOR
Drug: 40% Nitrous oxideDrug: 0.6% isoflurane

Interventions

40% Nitrous oxideDRUG

Used as pain assay positive control

0% isoflurane0.2% isoflurane0.4% isoflurane0.6% isoflurane
Sham comparatorOTHER

0% isoflurane in oxygen

0% isoflurane
0.2% isofluraneDRUG
0.2% isoflurane
0.4% isofluraneDRUG
0.4% isoflurane
0.6% isofluraneDRUG
0.6% isoflurane

Eligibility Criteria

Age21 Years - 34 Years
Sexmale
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, 1995, 83: A287

    BACKGROUND

MeSH Terms

Conditions

Opioid-Related DisordersSubstance-Related Disorders

Interventions

Nitrous OxideIsoflurane

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Nitrogen OxidesGasesInorganic ChemicalsNitrogen CompoundsOxidesOxygen CompoundsMethyl EthersEthersOrganic Chemicals

Study Officials

  • James Zacny, Ph.D.

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

January 1, 1995

Primary Completion

September 1, 1995

Study Completion

September 1, 1995

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

US(1)