NCT00000255

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 examine differential acute tolerance development to effects of nitrous oxide in humans.

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 Apr 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1995

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 1996

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 1996

Completed
3.4 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

1.1 years

First QC Date

September 20, 1999

Last Update Submit

May 26, 2015

Conditions

Opioid-Related DisordersSubstance-Related Disorders

Keywords

nitrous oxideacute tolerancesubjective effectsanalgesiapsychomotorhealthy volunteer

Outcome Measures

Primary Outcomes (1)

  • Pain intensity, pain bothersomeness

    Subjects will inhale varying conc of nitrous oxide for 120 min with cold immersion of forearm at 25, 70, and 115 min and 40 min after inhalation. Pain intensity and bothersomeness will be assessed at each immersion.

    25, 70, & 115 min of inhalation and 40 min post

Study Arms (5)

0% Nitrous oxide

PLACEBO COMPARATOR
Drug: Nitrous oxide

10% nitrous oxide

ACTIVE COMPARATOR
Drug: Nitrous oxide

20% nitrous oxide

ACTIVE COMPARATOR
Drug: Nitrous oxide

30% nitrous oxide

ACTIVE COMPARATOR
Drug: Nitrous oxide

40% nitrous oxide

ACTIVE COMPARATOR
Drug: Nitrous oxide

Interventions

Nitrous oxideDRUG
0% Nitrous oxide10% nitrous oxide20% nitrous oxide30% nitrous oxide40% nitrous oxide

Eligibility Criteria

Age21 Years - 37 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Please contact site for information.

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Sponsors & Collaborators

Study Sites (1)

University of Chicago, Anesthesia & Critical Care

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • Zacny JP, Cho AM, Coalson DW, Rupani G, Young CJ, Klafta JM, Klock PA, Apfelbaum JL. Differential acute tolerance development to effects of nitrous oxide in humans. Neurosci Lett. 1996 May 10;209(2):73-6. doi: 10.1016/0304-3940(96)12626-4.

    PMID: 8761985BACKGROUND

MeSH Terms

Conditions

Opioid-Related DisordersSubstance-Related DisordersAgnosia

Interventions

Nitrous Oxide

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental DisordersPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen OxidesGasesInorganic ChemicalsNitrogen CompoundsOxidesOxygen Compounds

Study Officials

  • James Zacny, Ph.D.

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
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

April 1, 1995

Primary Completion

May 1, 1996

Study Completion

May 1, 1996

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

US(1)