NCT00000264

Brief Summary

The purpose of this study is to examine the subjective, psychomotor, and reinforcing effects of combined alcohol and nitrous oxide intake in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 1997

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1997

Completed
2.1 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
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 1999

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 1999

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

2.1 years

First QC Date

September 20, 1999

Last Update Submit

May 26, 2015

Conditions

Opioid-Related DisordersSubstance-Related Disorders

Keywords

nitrous oxideinhalantethanolsubjective effectspsychomotor effectshealthy volunteer

Outcome Measures

Primary Outcomes (4)

  • Mood

    Baseline and post inhalation

  • Psychomotor performance

    Baseline and post inhalation

  • Cognitive performance

    Baseline and post inhalation

  • Choice of nitrous oxide vs placebo

    after each ethanol session

Study Arms (3)

0 g/Kg ethanol +/- 30% nitrous oxide

PLACEBO COMPARATOR
Drug: 30% Nitrous oxideOther: 0 g/Kg ethanol

0.35 g/Kg ethanol +/- 30% nitrous oxide

ACTIVE COMPARATOR
Drug: 30% Nitrous oxideOther: 0.35 g/Kg ethanol

0.7 g/Kg ethanol +/- 30% nitrous oxide

ACTIVE COMPARATOR
Drug: 30% Nitrous oxideOther: 0.7 g/Kg ethanol

Interventions

30% Nitrous oxideDRUG
0 g/Kg ethanol +/- 30% nitrous oxide0.35 g/Kg ethanol +/- 30% nitrous oxide0.7 g/Kg ethanol +/- 30% nitrous oxide
0.35 g/Kg ethanolOTHER
0.35 g/Kg ethanol +/- 30% nitrous oxide
0.7 g/Kg ethanolOTHER
0.7 g/Kg ethanol +/- 30% nitrous oxide
0 g/Kg ethanolOTHER
0 g/Kg ethanol +/- 30% nitrous oxide

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

MeSH Terms

Conditions

Opioid-Related DisordersSubstance-Related Disorders

Interventions

Nitrous OxideEthanol

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Nitrogen OxidesGasesInorganic ChemicalsNitrogen CompoundsOxidesOxygen CompoundsAlcoholsOrganic Chemicals

Study Officials

  • James Zacny, Ph.D.

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
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, 1997

Primary Completion

October 1, 1999

Study Completion

October 1, 1999

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

US(1)