Opioid-Related DisordersPhase 2NCT00000251
Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide - 3
A Phase 2 study testing 30% N2O, 0.2% isoflurane and 0.4% isoflurane 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 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid-Related Disorders, Substance-Related Disorders
- What is being tested?
- 30% N2O, 0.2% isoflurane and 0.4% isoflurane
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1994to Jan 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 32 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 Isoflurane/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 evaluate the acute and residual effects of subanesthetic concentrations of isoflurane/nitrous oxide combinations in healthy volunteers.
- Being tested
- 30% N2O, 0.2% isoflurane, 0.4% isoflurane, 100% oxygen
- Keywords
- nitrous oxide, isoflurane, subjective effects, psychomotor, healthy volunteer, drug interaction
- 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.
30% N2ODrug
0.2% isofluraneDrug
0.4% isofluraneDrug
100% oxygenOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects inhale 100% oxygen Receives: Other: 100% oxygen |
| 30% N2O | Active comparator | Subjects inhale 30% N2O Receives: Drug: 30% N2O |
| 0.2% isoflurane | Active comparator | Subjects inhale 0.2% isoflurane Receives: Drug: 0.2% isoflurane |
| 0.4% isoflurane | Active comparator | Subjects inhale 0.4% isoflurane Receives: Drug: 0.4% isoflurane |
| 0.2% isoflurane + 30% N2O | Active comparator | Subjects will inhale a combination of 0.2% isoflurane and 30% N2O Receives: Drug: 30% N2O; Drug: 0.2% isoflurane |
| 0.4% isoflurane + 30% N2O | Active comparator | Subjects will inhale a combination of 0.4% isoflurane and 30% N2O Receives: Drug: 30% N2O; Drug: 0.4% isoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Logical reasoning test
Measured: 15 & 30 min inhalation and 5, 30, & 60 min post inhalation
Free recall memory test
Measured: 15 & 30 min inhalation and 5, 30, & 60 min post inhalation
Auditory reaction time
Measured: 15 & 30 min inhalation and 5,30 & 60 min post inhalation
Digit symbol substitution test
Measured: 2,15 & 30 min inhalation and 5,30 & 60 min post 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 startApr 1994
- Primary completionJan 1996
- Study completionJan 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Single blind
- Who is masked
- Participant
- 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
- NCT00000251
- Sponsor's protocol ID
- NIDA-08391-3
- Other IDs
- R01DA008391, R01-08391-3
- Status last verified
- Nov 2015
- First submitted
- 20 Sep 1999
- Last updated
- 2 Dec 2015
- Results posted
- No
Publications
Zacny JP, Yajnik S, Lichtor JL, Klafta JM, Young CJ, Thapar P, Rupani G, Coalson DW, Apfelbaum JL. The acute and residual effects of subanesthetic concentrations of isoflurane/nitrous oxide combinations on cognitive and psychomotor performance in healthy volunteers. Anesth Analg. 1996 Jan;82(1):153-7. doi: 10.1097/00000539-199601000-00028.
PubMed 8712393Whelan J, Hackshaw A, McTiernan A, Grimer R, Spooner D, Bate J, Ranft A, Paulussen M, Juergens H, Craft A, Lewis I. Survival is influenced by approaches to local treatment of Ewing sarcoma within an international randomised controlled trial: analysis of EICESS-92. Clin Sarcoma Res. 2018 Mar 30;8:6. doi: 10.1186/s13569-018-0093-y. eCollection 2018.
PubMed 29610659
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide
- ClinicalTrials.gov ID
- NCT00000251
- Acronym / sponsor ID
- NIDA-08391-3
- Keywords
- nitrous oxide, isoflurane, subjective effects, psychomotor, healthy volunteer, drug interaction
- 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
- Apr 1994
- Primary completion
- Jan 1996 (actual)
- Study completion
- Jan 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 evaluate the acute and residual effects of subanesthetic concentrations of isoflurane/nitrous oxide combinations in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: 100% oxygenSubjects inhale 100% oxygen |
| 30% N2O | Active comparator | Drug: 30% N2OSubjects inhale 30% N2O |
| 0.2% isoflurane | Active comparator | Drug: 0.2% isofluraneSubjects inhale 0.2% isoflurane |
| 0.4% isoflurane | Active comparator | Drug: 0.4% isofluraneSubjects inhale 0.4% isoflurane |
| 0.2% isoflurane + 30% N2O | Active comparator | Drug: 30% N2O, Drug: 0.2% isofluraneSubjects will inhale a combination of 0.2% isoflurane and 30% N2O |
| 0.4% isoflurane + 30% N2O | Active comparator | Drug: 30% N2O, Drug: 0.4% isofluraneSubjects will inhale a combination of 0.4% isoflurane and 30% N2O |
Who may qualify
- Ages
- 21 to 32 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 |
|---|---|---|
| 30% N2O | Drug | 0.2% isoflurane + 30% N2O, 0.4% isoflurane + 30% N2O, 30% N2O |
| 0.2% isoflurane | Drug | 0.2% isoflurane, 0.2% isoflurane + 30% N2O |
| 0.4% isoflurane | Drug | 0.4% isoflurane, 0.4% isoflurane + 30% N2O |
| 100% oxygenPlacebo | Other | Placebo |
Primary outcome
Logical reasoning test
Time frame: 15 & 30 min inhalation and 5, 30, & 60 min post inhalation
Free recall memory test
Time frame: 15 & 30 min inhalation and 5, 30, & 60 min post inhalation
Auditory reaction time
Time frame: 15 & 30 min inhalation and 5,30 & 60 min post inhalation
Digit symbol substitution test
Time frame: 2,15 & 30 min inhalation and 5,30 & 60 min post inhalation
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 2 Dec 2015.
- Background: PubMed 8712393Zacny JP, Yajnik S, Lichtor JL, Klafta JM, Young CJ, Thapar P, Rupani G, Coalson DW, Apfelbaum JL. The acute and residual effects of subanesthetic concentrations of isoflurane/nitrous oxide combinations on cognitive and psychomotor performance in healthy volunteers. Anesth Analg. 1996 Jan;82(1):153-7. doi: 10.1097/00000539-199601000-00028.
- Derived from this study: PubMed 29610659Whelan J, Hackshaw A, McTiernan A, Grimer R, Spooner D, Bate J, Ranft A, Paulussen M, Juergens H, Craft A, Lewis I. Survival is influenced by approaches to local treatment of Ewing sarcoma within an international randomised controlled trial: analysis of EICESS-92. Clin Sarcoma Res. 2018 Mar 30;8:6. doi: 10.1186/s13569-018-0093-y. eCollection 2018.
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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 30% N2O, 0.2% isoflurane and 0.4% isoflurane 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 2 Dec 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?
Logical reasoning test (time frame: 15 & 30 min inhalation and 5, 30, & 60 min post inhalation). The study lists 4 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 NCT00000251, which also lists 2 linked publications.
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 2 Dec 2015.