Opioid-Related DisordersNCT00000258
Role of Instructions in Nitrous Oxide Effects and Choice - 10
A study of 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1996to Nov 1997
- Phase
- Interventional
- 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: Role of Instructions in Nitrous Oxide Effects and Choice
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. Comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To evaluate the role of instructions in nitrous oxide subjective effects and choice.
- Being tested
- Nitrous oxide 10% & placebo, Nitrous oxide 20% & placebo, Nitrous oxide 30% & placebo, Nitrous oxide 40% and placebo
- Keywords
- nitrous oxide, instruction, subjective effects, reinforcer, 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.
Nitrous oxide 10% & placeboDrug
Nitrous oxide 20% & placeboDrug
Nitrous oxide 30% & placeboDrug
Nitrous oxide 40% and placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Informed group | Active comparator | Group inhaled placebo and varying doses of nitrous oxide in pairs then chose which they wanted for a third inhalation. Receives: Drug: Nitrous oxide 10% & placebo; Drug: Nitrous oxide 20% & placebo; Drug: Nitrous oxide 30% & placebo; Drug: Nitrous oxide 40% and placebo |
| Non-informed Group | Active comparator | Group and technician were blinded as to which gas they were inhaling in pairs with third inhalation subject's choice. Receives: Drug: Nitrous oxide 10% & placebo; Drug: Nitrous oxide 20% & placebo; Drug: Nitrous oxide 30% & placebo; Drug: Nitrous oxide 40% and placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choice of nitrous oxide vs placebo
Subjects inhaled placebo and varying per centages of nitrous oxide in sampling pair, then chose for third inhalation. One group was told which of the gases they were inhaling during sampling and one group as well as the technician administering the inhalant was blinded. Psychomotor tests were done at each dose.
Measured: After 30 min inhalation of each
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 1996
- Primary completionNov 1997
- Study completionNov 1997
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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 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
- NCT00000258
- Sponsor's protocol ID
- NIDA-08391-10
- Other IDs
- R01DA008391, R01-08391-10
- Status last verified
- May 2015
- First submitted
- 20 Sep 1999
- Last updated
- 28 May 2015
- Results posted
- No
Publications
Zacny JP, Cho AM, Toledano AY, Galinkin J, Coalson DW, Klock PA, Klafta JM, Young CJ. Effects of information on the reinforcing, subjective, and psychomotor effects of nitrous oxide in healthy volunteers. Drug Alcohol Depend. 1997 Nov 25;48(2):85-95. doi: 10.1016/s0376-8716(97)00114-2.
PubMed 9363407
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
- Role of Instructions in Nitrous Oxide Effects and Choice
- ClinicalTrials.gov ID
- NCT00000258
- Acronym / sponsor ID
- NIDA-08391-10
- Keywords
- nitrous oxide, instruction, subjective effects, reinforcer, healthy volunteer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 1996
- Primary completion
- Nov 1997 (actual)
- Study completion
- Nov 1997 (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. Comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To evaluate the role of instructions in nitrous oxide subjective effects and choice.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Informed group | Active comparator | Drug: Nitrous oxide 10% & placebo, Drug: Nitrous oxide 20% & placebo, Drug: Nitrous oxide 30% & placebo, Drug: Nitrous oxide 40% and placeboGroup inhaled placebo and varying doses of nitrous oxide in pairs then chose which they wanted for a third inhalation. |
| Non-informed Group | Active comparator | Drug: Nitrous oxide 10% & placebo, Drug: Nitrous oxide 20% & placebo, Drug: Nitrous oxide 30% & placebo, Drug: Nitrous oxide 40% and placeboGroup and technician were blinded as to which gas they were inhaling in pairs with third inhalation subject's choice. |
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 |
|---|---|---|
| Nitrous oxide 10% & placebo | Drug | Informed group, Non-informed Group |
| Nitrous oxide 20% & placebo | Drug | Informed group, Non-informed Group |
| Nitrous oxide 30% & placebo | Drug | Informed group, Non-informed Group |
| Nitrous oxide 40% and placebo | Drug | Informed group, Non-informed Group |
Primary outcome
Choice of nitrous oxide vs placebo
Time frame: After 30 min inhalation of each
Subjects inhaled placebo and varying per centages of nitrous oxide in sampling pair, then chose for third inhalation. One group was told which of the gases they were inhaling during sampling and one group as well as the technician administering the inhalant was blinded. Psychomotor tests were done at each dose.
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 9363407Zacny JP, Cho AM, Toledano AY, Galinkin J, Coalson DW, Klock PA, Klafta JM, Young CJ. Effects of information on the reinforcing, subjective, and psychomotor effects of nitrous oxide in healthy volunteers. Drug Alcohol Depend. 1997 Nov 25;48(2):85-95. doi: 10.1016/s0376-8716(97)00114-2.
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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 study of 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.
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?
Choice of nitrous oxide vs placebo (time frame: After 30 min inhalation of each). 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 NCT00000258, 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.