Completed

Effects of Alcohol History on Effects of Sevoflurane and Nitrous Oxide - 13

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What is being tested

30% Nitrous oxide

+ Placebo
+ 0.2% sevoflurane
Drug
Other
Who is being recruted

Alcohol-Related Disorders

+ Opioid-Related Disorders
+ Substance-Related Disorders

See all eligibility criteria

How is the trial designed

Other Study

Phase 2
Interventional
Study Start: November 1997

See protocol details

Summary

Principal SponsorUniversity of Chicago
Last updated: May 27, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 1997Actual date on which the first participant was enrolled.

The purpose of this study is to evaluate the effects of alcohol history on the subjective and reinforcing effects of sevoflurane and nitrous oxide in healthy volunteers. All subjects underwent psychomotor testing during 4 sessions of placebo, drug/placebo, and choice of intervention.

Official TitleEffects of Alcohol History on Effects of Sevoflurane and Nitrous Oxide 
Principal SponsorUniversity of Chicago
Last updated: May 27, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
14 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Alcohol-Related Disorders
Opioid-Related Disorders
Substance-Related Disorders
Criteria

Please contact site for information.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Study Objectives
Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
University of Chicago, Anesthesia & Critical CareChicago, United StatesSee the location
CompletedOne Study Center