Completed

Subjective/Psychomotor/ Effects of Combined Alcohol & Nitrous Oxide - 16

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

30% Nitrous oxide

+ 0.35 g/Kg ethanol
+ 0.7 g/Kg ethanol
Drug
Other
Who is being recruted

Opioid-Related Disorders

+ Substance-Related Disorders

See all eligibility criteria

How is the trial designed

Other Study

Placebo-Controlled
Interventional
Study Start: September 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: September 1, 1997Actual date on which the first participant was enrolled.

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

Official TitleSubjective/Psychomotor/ Effects of Combined Alcohol & 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
8 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.

How treatments are given to participants
Participants receive different treatments one after the other, switching from one to another during the study. This helps researchers understand how individuals respond to multiple treatments.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
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 placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

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 allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Opioid-Related Disorders
Substance-Related Disorders
Criteria

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Study Plan

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

are designated in this study

33.333% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Placebo
Group II
Active Comparator
Group III
Active Comparator
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