Effects of Combined Alcohol and Nitrous Oxide Intake - 15 | NCT00000263

Studies
Effects of Combined Alcohol and Nitrous Oxide Intake - 15

NCT00000263

Sponsor

University of Chicago

Status

Completed

Last Update Posted

May 27, 2015Estimated

Enrollment

11Actual

Phase

Not Applicable

Conditions

Opioid-Related Disorders
Substance-Related Disorders

Interventions

30% Nitrous oxide
0.25 g/Kg ethanol
0.5 g/KG ethanol
0 g/Kg ethanol

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01DA008391	U.S. NIH Grant/Contract		View source
R01-08391-15

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1997

Primary Completion Date

Oct 1998Actual

Completion Date

Oct 1998Actual

First Submitted Date

Sep 20, 1999

First Submission Date that Met QC Criteria

Sep 20, 1999

First Posted Date

Sep 21, 1999Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2015

Last Update Posted Date

May 27, 2015Estimated

Name	Class
National Institute on Drug Abuse (NIDA)	NIH

Description Module

Brief Summary

The purpose of this study is to determine the effects of combined alcohol and nitrous oxide intake on mood, psychomotor performance, and the pain response in healthy volunteers.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
0 g/Kg ethanol +/- 30% nitrous oxide	Placebo Comparator	Drug: 30% Nitrous oxide Other: 0 g/Kg ethanol
0.25 g/Kg ethanol +/- 30% nitrous oxide	Active Comparator	Drug: 30% Nitrous oxide Other: 0.25 g/Kg ethanol
0.5 g/Kg ethanol +/- 30% nitrous oxide	Active Comparator	Drug: 30% Nitrous oxide Other: 0.5 g/KG ethanol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
30% Nitrous oxide	Drug		0 g/Kg ethanol +/- 30% nitrous oxide 0.25 g/Kg ethanol +/- 30% nitrous oxide 0.5 g/Kg ethanol +/- 30% nitrous oxide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain intensity, pain bothersomeness		Post inhalation
Mood		Post inhalation
Psychomotor performance		Post inhalation
Cognitive performance		Post inhalation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Please contact site for information.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James Zacny, Ph.D.	University of Chicago	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Chicago, Anesthesia & Critical Care		Chicago	Illinois	60637	United States

Condition Browse Module

MeSH Terms

ID	Term
D009293	Opioid-Related Disorders
D019966	Substance-Related Disorders

Ancestor Terms

ID	Term
D000079524	Narcotic-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009609	Nitrous Oxide
D000431	Ethanol

Ancestor Terms

ID	Term
D009589	Nitrogen Oxides
D005740	Gases
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds

Browse Leaves

Not provided

Browse Branches

Not provided