Opioid-Related DisordersPhase 2NCT00000252
Lack of Acute Tolerance Development to Effects of Nitrous Oxide - 4
A Phase 2 study testing 0% N2O, 10% N2O and 20% N2O in people with Opioid-Related Disorders and Substance-Related Disorders, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid-Related Disorders, Substance-Related Disorders
- What is being tested?
- 0% N2O, 10% N2O and 20% N2O
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1994to Jun 1996
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Please contact site for information.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago, Anesthesia & Critical Care
Chicago, Illinois, 60637
About this study
Official title: Lack of Acute Tolerance Development to Effects of Nitrous Oxide
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.
- Being tested
- 0% N2O, 10% N2O, 20% N2O, 30% N2O, 40% N2O
- Keywords
- nitrous oxide, acute tolerance, subjective effects, psychomotor, analgesia, healthy volunteer
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0% N2ODrug
10% N2ODrug
20% N2ODrug
30% N2ODrug
40% N2ODrug
| Study group | Role | What they receive |
|---|---|---|
| 0% N2O | Sham comparator | Subjects will inhale 0% N2O Receives: Drug: 0% N2O |
| 10% N2O | Active comparator | Subjects will inhale 10% N2O Receives: Drug: 10% N2O |
| 20% N2O | Active comparator | Subjects will inhale 20% N2O Receives: Drug: 20% N2O |
| 30% N2O | Active comparator | Subjects will inhale 30% N2O Receives: Drug: 30% N2O |
| 40% N2O | Active comparator | Subjects will inhale 40% N2O Receives: Drug: 40% N2O |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychomotor performance
Subjects will undergo psychomotor testing during 120 min inhalation session of each intervention
Measured: During inhalation
Cognitive performance
Subjects will under cognitive testing during 120 minute inhalation session of each intervention
Measured: During inhalation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 1999 (estimated)
- Study startJun 1994
- Primary completionJun 1996
- Study completionJun 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- James Zacny, Ph.D., Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000252
- Sponsor's protocol ID
- NIDA-08391-4
- Other IDs
- R01DA008391, R01-08391-4
- Status last verified
- May 2015
- First submitted
- 20 Sep 1999
- Last updated
- 28 May 2015
- Results posted
- No
Publications
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.
PubMed 8743615
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lack of Acute Tolerance Development to Effects of Nitrous Oxide
- ClinicalTrials.gov ID
- NCT00000252
- Acronym / sponsor ID
- NIDA-08391-4
- Keywords
- nitrous oxide, acute tolerance, subjective effects, psychomotor, analgesia, healthy volunteer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 1994
- Primary completion
- Jun 1996 (actual)
- Study completion
- Jun 1996 (actual)
- First posted
- 21 Sep 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 0% N2O | Sham comparator | Drug: 0% N2OSubjects will inhale 0% N2O |
| 10% N2O | Active comparator | Drug: 10% N2OSubjects will inhale 10% N2O |
| 20% N2O | Active comparator | Drug: 20% N2OSubjects will inhale 20% N2O |
| 30% N2O | Active comparator | Drug: 30% N2OSubjects will inhale 30% N2O |
| 40% N2O | Active comparator | Drug: 40% N2OSubjects will inhale 40% N2O |
Who may qualify
- Ages
- 21 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0% N2O | Drug | 0% N2O |
| 10% N2O | Drug | 10% N2O |
| 20% N2O | Drug | 20% N2O |
| 30% N2O | Drug | 30% N2O |
| 40% N2O | Drug | 40% N2O |
Primary outcome
Psychomotor performance
Time frame: During inhalation
Subjects will undergo psychomotor testing during 120 min inhalation session of each intervention
Cognitive performance
Time frame: During inhalation
Subjects will under cognitive testing during 120 minute inhalation session of each intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Background: PubMed 8743615Yajnik 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.
Related trials for Opioid-Related Disorders
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
Active, not recruiting
EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy
Substance Use Disorders, Opioid Use Disorder, Severe
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Zacny, Ph.D. principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0% N2O, 10% N2O and 20% N2O in people with Opioid-Related Disorders and Substance-Related Disorders, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychomotor performance (time frame: During inhalation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000252, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.