HealthyNCT00947284
Effect of Nalbuphine and Naloxone on Experimentally Induced Skin Sensitivity
A study testing nalbuphine plus naloxone, nalbuphine plus saline and naloxone plus saline in people with Healthy, run by University of California, San Francisco at 1 site in United States.
Trial summary
In previous clinical studies of post-surgical pain the investigators found that nalbuphine (Nubain), a narcotic pain killer, relieves pain more effectively when combined with low-dose naloxone (Narcan), a drug that is used to treat narcotic overdose. This finding was particularly true in men. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- nalbuphine plus naloxone, nalbuphine plus saline and naloxone plus saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 - 40
- In stable health
- Speak, read, understand English language
- If female, must be non-lactating and not pregnant
Who cannot join
- Heat pain detection thresholds above 47 ºC/116.6 ºF
- Inability to develop secondary hyperalgesia from the heat and capsaicin stimulation performed at the screening visit
- Serious psychiatric psychopathology (psychotic disorder, substance abuse)
- Tattoos in the area of measurements
- Allergy to study drugs (nalbuphine, naloxone, or capsaicin)
- Current or recent use opioids
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California
San Francisco, California, 94143
About this study
Official title: Effect of Kappa Opioid Agonist-Antagonists in the Heat/Capsaicin Sensitization Model
In previous clinical studies of post-surgical pain the investigators found that nalbuphine (Nubain), a narcotic pain killer, relieves pain more effectively when combined with low-dose naloxone (Narcan), a drug that is used to treat narcotic overdose. This finding was particularly true in men. The purpose of this study is to find out if nalbuphine combined with naloxone is more effective in relieving experimentally produced pain than either drug alone. A second reason for this study is to find out if study medications work more effectively in women or in men. Subjects will come to the University of California at San Francisco (UCSF) Clinical Research Center (CRC) for 4 study visits. The first visit will be a 2-hour screening to assess the subject for study eligibility. During the other three visits, the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
- Conditions
- Healthy
- Being tested
- nalbuphine plus naloxone, nalbuphine plus saline, naloxone plus saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nalbuphine plus naloxoneDrug
Also called Nubain, Narcan
single dose administered intravenously
nalbuphine plus salineDrug
Also called Nubain
single dose administered intravenously
naloxone plus salineDrug
Also called Narcan
single dose administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Women | Experimental | Both arms of this study will receive identical interventions. The only difference will be the sex of the participants in each study arm. Receives: Drug: nalbuphine plus naloxone; Drug: nalbuphine plus saline; Drug: naloxone plus saline |
| Men | Experimental | Both arms of this study will receive identical interventions. The only difference will be the sex of the participants in each study arm Receives: Drug: nalbuphine plus naloxone; Drug: nalbuphine plus saline; Drug: naloxone plus saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Skin Sensitivity as Measured by a Visual Analog Scale
Participants would have been asked to rate the level of pain on a scale from 0 (no pain) to 10 (worst pain imaginable).
Measured: Prior to drug administration and 20 minutes, 70 minutes and 2 hours after each drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startJan 2010
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: Experimental pain model didn't work as anticipated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jon D Levine, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947284
- Sponsor's protocol ID
- NIH/NIDCR R01 DE018526-2
- Other IDs
- 5R01DE018526-02
- Status last verified
- Oct 2013
- First submitted
- 1 Jul 2009
- Last updated
- 20 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kappa Opioid Agonist-Antagonists in the Heat/Capsaicin Sensitization Model
- ClinicalTrials.gov ID
- NCT00947284
- Acronym / sponsor ID
- NIH/NIDCR R01 DE018526-2
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Experimental pain model didn't work as anticipated.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 28 Jul 2009 (estimated)
- Results
- Posted 23 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In previous clinical studies of post-surgical pain the investigators found that nalbuphine (Nubain), a narcotic pain killer, relieves pain more effectively when combined with low-dose naloxone (Narcan), a drug that is used to treat narcotic overdose. This finding was particularly true in men. The purpose of this study is to find out if nalbuphine combined with naloxone is more effective in relieving experimentally produced pain than either drug alone. A second reason for this study is to find out if study medications work more effectively in women or in men. Subjects will come to the University of California at San Francisco (UCSF) Clinical Research Center (CRC) for 4 study visits. The first visit will be a 2-hour screening to assess the subject for study eligibility. During the other three visits, the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women | Experimental | Drug: nalbuphine plus naloxone, Drug: nalbuphine plus saline, Drug: naloxone plus salineBoth arms of this study will receive identical interventions. The only difference will be the sex of the participants in each study arm. |
| Men | Experimental | Drug: nalbuphine plus naloxone, Drug: nalbuphine plus saline, Drug: naloxone plus salineBoth arms of this study will receive identical interventions. The only difference will be the sex of the participants in each study arm |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 - 40
- In stable health
- Speak, read, understand English language
- If female, must be non-lactating and not pregnant
Key exclusion criteria (6 listed)
- Heat pain detection thresholds above 47 ºC/116.6 ºF
- Inability to develop secondary hyperalgesia from the heat and capsaicin stimulation performed at the screening visit
- Serious psychiatric psychopathology (psychotic disorder, substance abuse)
- Tattoos in the area of measurements
- Allergy to study drugs (nalbuphine, naloxone, or capsaicin)
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 |
|---|---|---|
| nalbuphine plus naloxoneAlso: Nubain, Narcansingle dose administered intravenously | Drug | Men, Women |
| nalbuphine plus salineAlso: Nubainsingle dose administered intravenously | Drug | Men, Women |
| naloxone plus salineAlso: Narcansingle dose administered intravenously | Drug | Men, Women |
Primary outcome
Change in Skin Sensitivity as Measured by a Visual Analog Scale
Time frame: Prior to drug administration and 20 minutes, 70 minutes and 2 hours after each drug administration
Participants would have been asked to rate the level of pain on a scale from 0 (no pain) to 10 (worst pain imaginable).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jon D Levine, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nalbuphine plus naloxone, nalbuphine plus saline and naloxone plus saline in people with Healthy, run by University of California, San Francisco 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?
The sponsor lists 4 inclusion and 6 exclusion criteria. 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: stopped early, as of the sponsor's last update on 20 May 2016. 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?
Yes. Results are posted in the registry (first posted 23 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Skin Sensitivity as Measured by a Visual Analog Scale (time frame: Prior to drug administration and 20 minutes, 70 minutes and 2 hours after each drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2016.