NCT00000256

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. Comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To examine reinforcing effects of brief exposures to nitrous oxide in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 1995

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

August 1, 1995

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 1996

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 1996

Completed
2.9 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 oxidereinforcersubjective effectshealthy volunteer

Outcome Measures

Primary Outcomes (1)

  • Choice of nitrous oxide 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 1.5 min of inhalation each of nitrous oxide then placebo

Study Arms (4)

Placebo + 20% N2O

ACTIVE COMPARATOR

0% N2O inhaled during psychomotor testing, 20% N2O inhaled during psycho motor testing, then subject's choice of the 2.

Drug: 20% N2O

Placebo + 40% N2O

ACTIVE COMPARATOR

0% N2O inhaled during psychomotor testing, 40% N2O inhaled during psycho motor testing, then subject's choice of the 2.

Drug: 40% N2O

Placebo + 60% N2O

ACTIVE COMPARATOR

0% N2O inhaled during psychomotor testing, 60% N2O inhaled during psycho motor testing, then subject's choice of the 2.

Drug: 60% N2O

Placebo + 80% N2O

ACTIVE COMPARATOR

0% N2O inhaled during psychomotor testing, 80% N2O inhaled during psycho motor testing, then subject's choice of the 2.

Drug: 80% N2O

Interventions

Placebo + 20% N2O
Placebo + 40% N2O
Placebo + 60% N2O
Placebo + 80% N2O

Eligibility Criteria

Age22 Years - 34 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, Klafta JM, Coalson DW, Marks S, Young CJ, Klock PA, Toledano AY, Jordan N, Apfelbaum JL. The reinforcing effects of brief exposures to nitrous oxide in healthy volunteers. Drug Alcohol Depend. 1996 Nov;42(3):197-200. doi: 10.1016/s0376-8716(96)01281-1.

    PMID: 8912802BACKGROUND

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

August 1, 1995

Primary Completion

November 1, 1996

Study Completion

November 1, 1996

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations