NCT00000257

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 determine effects of alcohol history on the reinforcing, subjective and psychomotor effects of nitrous oxide in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1995

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 1997

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 1997

Completed
2.5 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 oxidesubjective effectsethanolhealthy volunteer

Outcome Measures

Primary Outcomes (1)

  • Choice of nitrous oxide vs placebo

    Two subject groups (light drinkers vs moderate drinkers) were asked to inhale a given conc of N2O and inhale a placebo, then choose for a third inhalation. The subject \& the technician administering the inhalant were blinded. Testing was done at each dose.

    After 30 min inhalation each of N2O and placebo

Study Arms (2)

Light drinkers

ACTIVE COMPARATOR
Drug: 0% N2O and 10% N2ODrug: 0% N2O and 20% N2ODrug: 0% N2O and 30% N2ODrug: 0% N2O and 40% N2O

Moderate drinkers

ACTIVE COMPARATOR
Drug: 0% N2O and 10% N2ODrug: 0% N2O and 20% N2ODrug: 0% N2O and 30% N2ODrug: 0% N2O and 40% N2O

Interventions

Light drinkersModerate drinkers
Light drinkersModerate drinkers
Light drinkersModerate drinkers
Light drinkersModerate drinkers

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)

  • Cho AM, Coalson DW, Klock PA, Klafta JM, Marks S, Toledano AY, Apfelbaum JL, Zacny JP. The effects of alcohol history on the reinforcing, subjective and psychomotor effects of nitrous oxide in healthy volunteers. Drug Alcohol Depend. 1997 Apr 14;45(1-2):63-70. doi: 10.1016/s0376-8716(97)01346-x.

    PMID: 9179508BACKGROUND

MeSH Terms

Conditions

Alcohol-Related DisordersOpioid-Related DisordersSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersNarcotic-Related 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

September 1, 1995

Primary Completion

April 1, 1997

Study Completion

April 1, 1997

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations