Opioid-Related DisordersPhase 2NCT00000254
Isoflurane at Subanesthetic Concentrations - 6
A Phase 2 study testing 40% Nitrous oxide, 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 34 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Opioid-Related Disorders, Substance-Related Disorders
- What is being tested?
- 40% Nitrous oxide, 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
- Jan 1995to Sep 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 34 years
- Men only
- 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: Isoflurane at Subanesthetic Concentrations
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 test the hypothesis that isoflurane at subanesthetic concentrations does not reduce cold-water immersion pain in healthy volunteers.
- Being tested
- 40% Nitrous oxide, Sham comparator, 0.2% isoflurane, 0.4% isoflurane, 0.6% isoflurane
- Keywords
- isoflurane, general anesthetic, inhalant, 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.
40% Nitrous oxideDrug
Used as pain assay positive control
Sham comparatorOther
0% isoflurane in oxygen
0.2% isofluraneDrug
0.4% isofluraneDrug
0.6% isofluraneDrug
| Study group | Role | What they receive |
|---|---|---|
| 0% isoflurane | Sham comparator | Not described Receives: Drug: 40% Nitrous oxide; Other: Sham comparator |
| 0.2% isoflurane | Active comparator | Not described Receives: Drug: 40% Nitrous oxide; Drug: 0.2% isoflurane |
| 0.4% isoflurane | Active comparator | Not described Receives: Drug: 40% Nitrous oxide; Drug: 0.4% isoflurane |
| 0.6% isoflurane | Active comparator | Not described Receives: Drug: 40% Nitrous oxide; Drug: 0.6% isoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain response
Effects of inhaled isoflurane on pain from immersion of subject's arm in ice cold water. Nitrous oxide (40%) was used as a positive control to confirm sensitivity of the pain assay.
Measured: 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 startJan 1995
- Primary completionSep 1995
- Study completionSep 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
- 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
- NCT00000254
- Sponsor's protocol ID
- NIDA-08391-6
- Other IDs
- R01DA008391, R01-08391-6
- Status last verified
- May 2015
- First submitted
- 20 Sep 1999
- Last updated
- 28 May 2015
- Results posted
- No
Publications
Anesthesiology, 1995, 83: A287
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
- Isoflurane at Subanesthetic Concentrations
- ClinicalTrials.gov ID
- NCT00000254
- Acronym / sponsor ID
- NIDA-08391-6
- Keywords
- isoflurane, general anesthetic, inhalant, 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
- Jan 1995
- Primary completion
- Sep 1995 (actual)
- Study completion
- Sep 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 test the hypothesis that isoflurane at subanesthetic concentrations does not reduce cold-water immersion pain in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0% isoflurane | Sham comparator | Drug: 40% Nitrous oxide, Other: Sham comparator |
| 0.2% isoflurane | Active comparator | Drug: 40% Nitrous oxide, Drug: 0.2% isoflurane |
| 0.4% isoflurane | Active comparator | Drug: 40% Nitrous oxide, Drug: 0.4% isoflurane |
| 0.6% isoflurane | Active comparator | Drug: 40% Nitrous oxide, Drug: 0.6% isoflurane |
Who may qualify
- Ages
- 21 to 34 years
- Sex
- Male only
- 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 |
|---|---|---|
| 40% Nitrous oxideUsed as pain assay positive control | Drug | 0% isoflurane, 0.2% isoflurane, 0.4% isoflurane, 0.6% isoflurane |
| Sham comparator0% isoflurane in oxygen | Other | 0% isoflurane |
| 0.2% isoflurane | Drug | 0.2% isoflurane |
| 0.4% isoflurane | Drug | 0.4% isoflurane |
| 0.6% isoflurane | Drug | 0.6% isoflurane |
Primary outcome
Pain response
Time frame: Post inhalation
Effects of inhaled isoflurane on pain from immersion of subject's arm in ice cold water. Nitrous oxide (40%) was used as a positive control to confirm sensitivity of the pain assay.
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.
- BackgroundAnesthesiology, 1995, 83: A287
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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 40% Nitrous oxide, 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 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?
Pain response (time frame: Post 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 NCT00000254, 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.