NCT00000249

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 effects of subanesthetic concentrations of nitrous oxide on cold-pressor pain 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 Sep 1993

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

September 1, 1993

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 1995

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1995

Completed
4.3 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

1.7 years

First QC Date

September 20, 1999

Last Update Submit

May 26, 2015

Conditions

Opioid-Related DisordersSubstance-Related Disorders

Keywords

nitrous oxidesubjective effectshealthy volunteer

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Subjects immersed non-dominant arm for 3 minutes twice in 2-3 degree C water while inhaling 0 (placebo), 20, 30, or 40% N2O for a total of 40 minutes

    during cold test at 10 min & 30 min of inhalation

Study Arms (4)

Control

NO INTERVENTION

Subject inhaled 0% N2O for 40 minutes with cold immersion at 10 and 30 minutes

20% N2O

ACTIVE COMPARATOR

Subject inhaled 20% N2O for 40 minutes with cold immersion at 10 \& 30 minutes

Drug: 20% N2O

30% N2O

ACTIVE COMPARATOR

Subject inhaled 30% N2O for 40 minutes with cold immersion at 10 and 30 minutes

Drug: 30% N2O

40% N2O

ACTIVE COMPARATOR

Subject inhaled 40% N2O for 40 minutes with cold immersion at 10 and 30 minutes

Drug: 40% N2O

Interventions

20% N2ODRUG

20% inhaled N2O

20% N2O
30% N2ODRUG

30% inhaled N2O

30% N2O
40% N2ODRUG

40% inhaled N2O

40% N2O

Eligibility Criteria

Age21 Years - 37 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)

  • Pharmocol Biochem and Behavior 1995, 51( 2): 323-329

    BACKGROUND

MeSH Terms

Conditions

Opioid-Related DisordersSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • James Zacny, Ph.D.

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON 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

September 1, 1993

Primary Completion

June 1, 1995

Study Completion

June 1, 1995

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

US(1)