NCT00000250

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 evaluate: cold water immersion modulates the reinforcing effects of nitrous oxide in healthy volunteers.

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 phase_2

Timeline
Completed

Started Dec 1993

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

December 1, 1993

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 1995

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 1995

Completed
4.4 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

1.4 years

First QC Date

September 20, 1999

Last Update Submit

May 26, 2015

Conditions

Opioid-Related DisordersSubstance-Related Disorders

Keywords

nitrous oxidechoicesubjective effectspainanalgesiareinforcerhealthy volunteer

Outcome Measures

Primary Outcomes (1)

  • Subject's choice of intervention

    After sampling trials

Study Arms (2)

Lukewarm water

ACTIVE COMPARATOR

Subjects will immerse forearm in lukewarm water while inhaling 0% and 40% N2O in 2 sampling trials, then choose between intervntions for one choice trial

Drug: 0% N2ODrug: 40% N2O

Ice cold water

ACTIVE COMPARATOR

Subjects will immerse forearm in ice cold water while inhaling 0% and 40% N2O in 2 sampling trials, then choose between intervntions for one choice trial

Drug: 0% N2ODrug: 40% N2O

Interventions

0% N2ODRUG

Subjects will inhale 100% oxygen with no N2O for 25 min then immerse forearm in warm water and cold water

Ice cold waterLukewarm water
40% N2ODRUG

Subjects will inhale 40% N2O then immerse forearm in warm water and cold water

Ice cold waterLukewarm water

Eligibility Criteria

Age21 Years - 32 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)

  • Experimentall Clinical Psycopharmacoly 1995, 3(2):148-155

    BACKGROUND

MeSH Terms

Conditions

Opioid-Related DisordersSubstance-Related DisordersPainAgnosia

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • James Zacny, Ph.D.

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON 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

December 1, 1993

Primary Completion

May 1, 1995

Study Completion

May 1, 1995

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

US(1)