NCT00000258

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 evaluate the role of instructions in nitrous oxide subjective effects and choice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 1996

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

April 1, 1996

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 1997

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 1997

Completed
1.9 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

1.6 years

First QC Date

September 20, 1999

Last Update Submit

May 26, 2015

Conditions

Keywords

nitrous oxideinstructionsubjective effectsreinforcerhealthy volunteer

Outcome Measures

Primary Outcomes (1)

  • Choice of nitrous oxide vs placebo

    Subjects inhaled placebo and varying per centages of nitrous oxide in sampling pair, then chose for third inhalation. One group was told which of the gases they were inhaling during sampling and one group as well as the technician administering the inhalant was blinded. Psychomotor tests were done at each dose.

    After 30 min inhalation of each

Study Arms (2)

Informed group

ACTIVE COMPARATOR

Group inhaled placebo and varying doses of nitrous oxide in pairs then chose which they wanted for a third inhalation.

Drug: Nitrous oxide 10% & placeboDrug: Nitrous oxide 20% & placeboDrug: Nitrous oxide 30% & placeboDrug: Nitrous oxide 40% and placebo

Non-informed Group

ACTIVE COMPARATOR

Group and technician were blinded as to which gas they were inhaling in pairs with third inhalation subject's choice.

Drug: Nitrous oxide 10% & placeboDrug: Nitrous oxide 20% & placeboDrug: Nitrous oxide 30% & placeboDrug: Nitrous oxide 40% and placebo

Interventions

Informed groupNon-informed Group
Informed groupNon-informed Group
Informed groupNon-informed Group
Informed groupNon-informed Group

Eligibility Criteria

Age21 Years - 32 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)

  • Zacny JP, Cho AM, Toledano AY, Galinkin J, Coalson DW, Klock PA, Klafta JM, Young CJ. Effects of information on the reinforcing, subjective, and psychomotor effects of nitrous oxide in healthy volunteers. Drug Alcohol Depend. 1997 Nov 25;48(2):85-95. doi: 10.1016/s0376-8716(97)00114-2.

    PMID: 9363407BACKGROUND

MeSH Terms

Conditions

Opioid-Related DisordersSubstance-Related Disorders

Interventions

Nitrous Oxide

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental Disorders

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
not applicable
Allocation
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

April 1, 1996

Primary Completion

November 1, 1997

Study Completion

November 1, 1997

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations