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Lack of Acute Tolerance Development to Effects of Nitrous Oxide - 4

Primary Purpose

Opioid-Related Disorders, Substance-Related Disorders

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

0% N2O

10% N2O

20% N2O

30% N2O

40% N2O

About this trial

This is an interventional treatment trial for Opioid-Related Disorders focused on measuring nitrous oxide, acute tolerance, subjective effects, psychomotor, analgesia, healthy volunteer

Eligibility Criteria

21 Years - 29 Years (Adult)All SexesAccepts Healthy Volunteers

Please contact site for information.

Sites / Locations

University of Chicago, Anesthesia & Critical Care

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Sham Comparator

Active Comparator

Arm Label

0% N2O

10% N2O

20% N2O

30% N2O

40% N2O

Arm Description

Subjects will inhale 0% N2O

Subjects will inhale 10% N2O

Subjects will inhale 20% N2O

Subjects will inhale 30% N2O

Subjects will inhale 40% N2O

Outcomes

Primary Outcome Measures

Psychomotor performance

Subjects will undergo psychomotor testing during 120 min inhalation session of each intervention

Cognitive performance

Subjects will under cognitive testing during 120 minute inhalation session of each intervention

Secondary Outcome Measures

Full Information

NCT ID

NCT00000252

First Posted

September 20, 1999

Last Updated

May 26, 2015

Sponsor

University of Chicago

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT00000252

Brief Title

Lack of Acute Tolerance Development to Effects of Nitrous Oxide - 4

Official Title

Lack of Acute Tolerance Development to Effects of Nitrous Oxide

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

June 1994 (undefined)

Primary Completion Date

June 1996 (Actual)

Study Completion Date

June 1996 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Chicago

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

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. To examine the lack of acute tolerance development to the subjective, cognitive, and psychomotor effects of nitrous oxide in healthy volunteers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid-Related Disorders, Substance-Related Disorders

Keywords

nitrous oxide, acute tolerance, subjective effects, psychomotor, analgesia, healthy volunteer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0% N2O

Arm Type

Sham Comparator

Arm Description

Subjects will inhale 0% N2O

Arm Title

10% N2O

Arm Type

Active Comparator

Arm Description

Subjects will inhale 10% N2O

Arm Title

20% N2O

Arm Type

Active Comparator

Arm Description

Subjects will inhale 20% N2O

Arm Title

30% N2O

Arm Type

Active Comparator

Arm Description

Subjects will inhale 30% N2O

Arm Title

40% N2O

Arm Type

Active Comparator

Arm Description

Subjects will inhale 40% N2O

Intervention Type

Drug

Intervention Name(s)

0% N2O

Intervention Type

Drug

Intervention Name(s)

10% N2O

Intervention Type

Drug

Intervention Name(s)

20% N2O

Intervention Type

Drug

Intervention Name(s)

30% N2O

Intervention Type

Drug

Intervention Name(s)

40% N2O

Primary Outcome Measure Information:

Title

Psychomotor performance

Description

Subjects will undergo psychomotor testing during 120 min inhalation session of each intervention

Time Frame

During inhalation

Title

Cognitive performance

Description

Subjects will under cognitive testing during 120 minute inhalation session of each intervention

Time Frame

During inhalation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

29 Years

Accepts Healthy Volunteers

Eligibility Criteria

Please contact site for information.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Zacny, Ph.D.

Organizational Affiliation

University of Chicago

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Chicago, Anesthesia & Critical Care

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

8743615

Citation

Yajnik S, Zacny JP, Young CJ, Lichtor JL, Rupani G, Klafta JM, Coalson DW, Apfelbaum JL. Lack of acute tolerance development to the subjective, cognitive, and psychomotor effects of nitrous oxide in healthy volunteers. Pharmacol Biochem Behav. 1996 Jun;54(2):501-8. doi: 10.1016/0091-3057(95)02278-3.

Results Reference

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Lack of Acute Tolerance Development to Effects of Nitrous Oxide - 4

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