Opioid-Related DisordersPhase 2NCT00000249
Effects of Subanesthetic Concentrations of Nitrous Oxide - 1
A Phase 2 study testing 20% N2O, 30% N2O and 40% 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 37 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid-Related Disorders, Substance-Related Disorders
- What is being tested?
- 20% N2O, 30% N2O and 40% N2O
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1993to Jun 1995
- 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 37 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: Effects of Subanesthetic Concentrations 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 effects of subanesthetic concentrations of nitrous oxide on cold-pressor pain in humans.
- Being tested
- 20% N2O, 30% N2O, 40% N2O
- Keywords
- nitrous oxide, subjective effects, healthy volunteer
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20% N2ODrug
20% inhaled N2O
30% N2ODrug
30% inhaled N2O
40% N2ODrug
40% inhaled N2O
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Subject inhaled 0% N2O for 40 minutes with cold immersion at 10 and 30 minutes |
| 20% N2O | Active comparator | Subject inhaled 20% N2O for 40 minutes with cold immersion at 10 \& 30 minutes Receives: Drug: 20% N2O |
| 30% N2O | Active comparator | Subject inhaled 30% N2O for 40 minutes with cold immersion at 10 and 30 minutes Receives: Drug: 30% N2O |
| 40% N2O | Active comparator | Subject inhaled 40% N2O for 40 minutes with cold immersion at 10 and 30 minutes Receives: Drug: 40% N2O |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Subjects immersed non-dominant arm for 3 minutes twice in 2-3 degree C water while inhaling 0 (placebo), 20, 30, or 40% N2O for a total of 40 minutes
Measured: during cold test at 10 min & 30 min of 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 startSep 1993
- Primary completionJun 1995
- Study completionJun 1995
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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 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
- NCT00000249
- Sponsor's protocol ID
- NIDA-08391-1
- Other IDs
- R01DA008391, R01-08391-1
- Status last verified
- May 2015
- First submitted
- 20 Sep 1999
- Last updated
- 28 May 2015
- Results posted
- No
Publications
Pirec V, Patterson TH, Thapar P, Apfelbaum JL, Zacny JP. Effects of subanesthetic concentrations of nitrous oxide on cold-pressor pain in humans. Pharmacol Biochem Behav. 1995 Jun-Jul;51(2-3):323-9. doi: 10.1016/0091-3057(94)00388-y.
PubMed 7667348
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
- Effects of Subanesthetic Concentrations of Nitrous Oxide
- ClinicalTrials.gov ID
- NCT00000249
- Acronym / sponsor ID
- NIDA-08391-1
- Keywords
- nitrous oxide, subjective effects, healthy volunteer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 1993
- Primary completion
- Jun 1995 (actual)
- Study completion
- Jun 1995 (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 effects of subanesthetic concentrations of nitrous oxide on cold-pressor pain in humans.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Subject inhaled 0% N2O for 40 minutes with cold immersion at 10 and 30 minutes |
| 20% N2O | Active comparator | Drug: 20% N2OSubject inhaled 20% N2O for 40 minutes with cold immersion at 10 \& 30 minutes |
| 30% N2O | Active comparator | Drug: 30% N2OSubject inhaled 30% N2O for 40 minutes with cold immersion at 10 and 30 minutes |
| 40% N2O | Active comparator | Drug: 40% N2OSubject inhaled 40% N2O for 40 minutes with cold immersion at 10 and 30 minutes |
Who may qualify
- Ages
- 21 to 37 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 |
|---|---|---|
| 20% N2O20% inhaled N2O | Drug | 20% N2O |
| 30% N2O30% inhaled N2O | Drug | 30% N2O |
| 40% N2O40% inhaled N2O | Drug | 40% N2O |
Primary outcome
Pain intensity
Time frame: during cold test at 10 min & 30 min of inhalation
Subjects immersed non-dominant arm for 3 minutes twice in 2-3 degree C water while inhaling 0 (placebo), 20, 30, or 40% N2O for a total of 40 minutes
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 7667348Pirec V, Patterson TH, Thapar P, Apfelbaum JL, Zacny JP. Effects of subanesthetic concentrations of nitrous oxide on cold-pressor pain in humans. Pharmacol Biochem Behav. 1995 Jun-Jul;51(2-3):323-9. doi: 10.1016/0091-3057(94)00388-y.
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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 20% N2O, 30% N2O and 40% 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. 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?
Pain intensity (time frame: during cold test at 10 min & 30 min of inhalation). 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 NCT00000249, 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.