NCT00000253

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 the subjective, psychomotor, and reinforcing effects of nitrous oxide in healthy volunteers. This is a dose-response analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 1994

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, 1994

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 1996

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 1996

Completed
3.6 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

1.3 years

First QC Date

September 20, 1999

Last Update Submit

May 26, 2015

Conditions

Keywords

nitrous oxideinhalantsubjective effectshealthy volunteer

Outcome Measures

Primary Outcomes (1)

  • Choice of N2O vs. placebo

    Subjects underwent 4 sessions consisting of 2 sample tests (inhaling placebo and inhaling varying doses of N2O), then choosing which inhalant they wanted for a choice test. The subject \& the technician administering the inhalant were blinded. During each intervention and each session, subjects underwent psychomotor testing.

    After each pair of sample tests

Study Arms (4)

Placebo + 10% N2O

ACTIVE COMPARATOR

0% N2O inhaled during psychomotor testing, 10% N2O inhaled during psycho motor testing, then subject's choice of the 2.

Drug: 10% N2O

Placebo + 20% N2O

ACTIVE COMPARATOR

Placebo inhaled during psychomotor testing, 20% N2O inhaled during psychomotor testing, then subject's choice of the 2.

Drug: 20% N2O

Placebo + 30% N2O

ACTIVE COMPARATOR

Placebo inhaled during psychomotor testing, 30% N2O inhaled during psychomotor testing, then subject's choice of the 2.

Drug: 30% N2O

Placebo + 40% N2O

ACTIVE COMPARATOR

Placebo inhaled during psychomotor testing, 40% N2O inhaled during psychomotor testing, then subject's choice of the 2.

Drug: 40% N2O

Interventions

Placebo + 10% N2O
Placebo + 20% N2O
Placebo + 30% N2O
Placebo + 40% N2O

Eligibility Criteria

Age21 Years - 37 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
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

Related Publications (1)

  • Behavioral Pharmacology, 1996, 7: 194-199.

    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
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

November 1, 1994

Primary Completion

March 1, 1996

Study Completion

March 1, 1996

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations