Analgesic ResponseNCT02136784
Analgesic Response to Opioid Analgesics in Buprenorphine-Maintained Individuals
A study testing morphine sulfate, hydrocodone and hydromorphone HCI in people with Analgesic Response, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The aim of this study is to examine the effects of opioid analgesics on acute pain in participants maintained on buprenorphine+naloxone (Suboxone) for opioid use disorders. Seven medication conditions will be tested in a cold pressor test (CPT) paradigm. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Analgesic Response
- What is being tested?
- morphine sulfate, hydrocodone and hydromorphone HCI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Dec 2014
- 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 20 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male, in good general health
- 20-50 years old
- Fluent in English
- Maintained on buprenorphine for at least 3 months
- Able to complete testing/assessments for 7 test days within 12 weeks
- Approved for participation by buprenorphine-prescribing physician
Who cannot join
- Known hypersensitivity to any of the test opioids
- Urine test positive for opioids (other than buprenorphine) or other illicit substances
- Current use of any additional opioid or analgesic medication (other than buprenorphine), medical marijuana, MAOI, tricyclic antidepressant, duloxetine, gabapentin, pregabalin, or other medication considered unsafe or having potential to influence pain perception as determined by study physician.
- Presence of acute pain condition or planned surgery during the study period
- Unstable vital signs as determined by the study physician.
- Current pattern of alcohol, benzodiazepine, or other sedative hypnotic use, as determined by the study medical clinician, which would preclude safe participation in the study;
- Pending legal action or other situation that might prevent remaining in the area for the duration of the study
- Current medical or psychiatric condition that could detract from study objectives, place the participant at risk, or interfere with treatment goals
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
UCLA Integrated Substance Abuse Programs Outpatient Clinical Research Center
Los Angeles, California, 90025
Jessica Jenkins, MS, 310-267-5318, jenkinsj@ucla.edu
Maureen Hillhouse, PhD, 310-267-5308, hillhous@ucla.edu
About this study
The aim of this study is to examine the effects of opioid analgesics on acute pain in participants maintained on buprenorphine+naloxone (Suboxone) for opioid use disorders. Seven medication conditions will be tested in a cold pressor test (CPT) paradigm.
Read the detailed description
Study design is a single-blind examination of the analgesic effects of a single dose of seven test medications provided in an experimental pain paradigm using a cold pressor test (CPT). Test medication conditions include buprenorphine, morphine, hydromorphone, hydrocodone, oxycodone, and two placebo conditions to match test medication formulations (oral tablet, sublingual tablet). Each medication condition will be tested on separate days (seven total days, completing within 12 weeks), with random assignment to order of study medications. After screening, eligible participants will be scheduled for 7 days of testing with test days at least 3 days apart to provide a sufficient medication wash-out period. Pain testing will utilize cold pressor tests (CPT), in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance. Participants will be given a practice trial to provide familiarity with the test and reduce test anxiety. Two CPTs will occur on each test day, and pre- and post-CPT assessments will be administered. Blood samples will be taken on each test day to measure blood levels of buprenorphine. Daily procedures include: (1) A baseline CPT (BL-CPT), (2) Administration of the test medication (active drug or placebo), (3) CPT administered at the time of maximum drug effect (Tmax-CPT) specific to medication (range 30-120 minutes), (4) Pupillometry conducted at baseline (before BL-CPT), and at time of maximum drug effect (before Tmax-CPT). Each participant will be discharged after clinical determination of the participant's safety and well-being. Testing will continue until twelve trials of each medication condition are completed.
- Conditions
- Analgesic Response
- Being tested
- morphine sulfate, hydrocodone, hydromorphone HCI, oxycodone, buprenorphine
- Keywords
- pain, cold presser test, buprenorphine, opioids
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
morphine sulfateDrug
Also called 30 mg, single dose
Participants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance.
hydrocodoneDrug
Also called 10mg single dose
Participants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance.
hydromorphone HCIDrug
Also called 4 mg single dose
Participants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance.
oxycodoneDrug
Also called 10 mg single dose
Participants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance.
buprenorphineDrug
Also called 4 mg single dose
Participants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance.
oral tablet placeboDrug
Also called single dose
Participants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance.
sublingual tablet placeboDrug
Also called single dose
Participants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance.
| Study group | Role | What they receive |
|---|---|---|
| morphine sulfate | Experimental | 30mg, single dose, Receives: Drug: oral tablet placebo |
| hydrocodone | Experimental | 10mg single dose Receives: Drug: oral tablet placebo |
| hydromorphone HCI | Experimental | 4mg single dose Receives: Drug: oral tablet placebo |
| oxycodone | Experimental | 10 mg single dose Receives: Drug: oral tablet placebo |
| buprenorphine | Experimental | 4 mg single dose Receives: Drug: sublingual tablet placebo |
| oral tablet placebo | Placebo comparator | single dose Receives: Drug: morphine sulfate; Drug: hydrocodone; Drug: hydromorphone HCI; Drug: oxycodone |
| sublingual tablet placebo | Placebo comparator | single dose Receives: Drug: buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain detection
Pain detection is defined as the number of seconds it takes for the participant to feel pain.
Measured: 7 testing sessions over 12 weeks
Pain tolerance
Pain tolerance is defined as the number of seconds it takes before the participant removes his hand from the ice water.
Measured: 7 testing sessions over 12 weeks
Secondary outcomes (1)
Pupillometry results
Examine pupillometry results in the context of administered opioid medications and associated cold pressor tests.
Measured: 7 testing sessions over 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesic ResponseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Indivior Inc.
- Responsible party
- Principal investigator, Walter Ling, University of California, Los Angeles
- Investigators
- Walter Ling, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136784
- Sponsor's protocol ID
- 13-001175
- Status last verified
- May 2014
- First submitted
- 18 Mar 2014
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Response to Opioid Analgesics in Buprenorphine-Maintained Individuals
- ClinicalTrials.gov ID
- NCT02136784
- Acronym / sponsor ID
- 13-001175
- Conditions
- Analgesic Response
- Keywords
- pain, cold presser test, buprenorphine, opioids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Indivior Inc.
- Study start
- Apr 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 13 May 2014 (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 aim of this study is to examine the effects of opioid analgesics on acute pain in participants maintained on buprenorphine+naloxone (Suboxone) for opioid use disorders. Seven medication conditions will be tested in a cold pressor test (CPT) paradigm.
Detailed description
Study design is a single-blind examination of the analgesic effects of a single dose of seven test medications provided in an experimental pain paradigm using a cold pressor test (CPT). Test medication conditions include buprenorphine, morphine, hydromorphone, hydrocodone, oxycodone, and two placebo conditions to match test medication formulations (oral tablet, sublingual tablet). Each medication condition will be tested on separate days (seven total days, completing within 12 weeks), with random assignment to order of study medications. After screening, eligible participants will be scheduled for 7 days of testing with test days at least 3 days apart to provide a sufficient medication wash-out period. Pain testing will utilize cold pressor tests (CPT), in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance. Participants will be given a practice trial to provide familiarity with the test and reduce test anxiety. Two CPTs will occur on each test day, and pre- and post-CPT assessments will be administered. Blood samples will be taken on each test day to measure blood levels of buprenorphine. Daily procedures include: (1) A baseline CPT (BL-CPT), (2) Administration of the test medication (active drug or placebo), (3) CPT administered at the time of maximum drug effect (Tmax-CPT) specific to medication (range 30-120 minutes), (4) Pupillometry conducted at baseline (before BL-CPT), and at time of maximum drug effect (before Tmax-CPT). Each participant will be discharged after clinical determination of the participant's safety and well-being. Testing will continue until twelve trials of each medication condition are completed.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| morphine sulfate | Experimental | Drug: oral tablet placebo30mg, single dose, |
| hydrocodone | Experimental | Drug: oral tablet placebo10mg single dose |
| hydromorphone HCI | Experimental | Drug: oral tablet placebo4mg single dose |
| oxycodone | Experimental | Drug: oral tablet placebo10 mg single dose |
| buprenorphine | Experimental | Drug: sublingual tablet placebo4 mg single dose |
| oral tablet placebo | Placebo comparator | Drug: morphine sulfate, Drug: hydrocodone, Drug: hydromorphone HCI, Drug: oxycodonesingle dose |
| sublingual tablet placebo | Placebo comparator | Drug: buprenorphinesingle dose |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male, in good general health
- 20-50 years old
- Fluent in English
- Maintained on buprenorphine for at least 3 months
- Able to complete testing/assessments for 7 test days within 12 weeks
Key exclusion criteria (8 listed)
- Known hypersensitivity to any of the test opioids
- Urine test positive for opioids (other than buprenorphine) or other illicit substances
- Current use of any additional opioid or analgesic medication (other than buprenorphine), medical marijuana, MAOI, tricyclic antidepressant, duloxetine, gabapentin, pregabalin, or other medication considered unsafe or having potential to influence pain perception as determined by study physician.
- Presence of acute pain condition or planned surgery during the study period
- Unstable vital signs as determined by the study physician.
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 |
|---|---|---|
| morphine sulfateAlso: 30 mg, single doseParticipants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance. | Drug | oral tablet placebo |
| hydrocodoneAlso: 10mg single doseParticipants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance. | Drug | oral tablet placebo |
| hydromorphone HCIAlso: 4 mg single doseParticipants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance. | Drug | oral tablet placebo |
| oxycodoneAlso: 10 mg single doseParticipants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance. | Drug | oral tablet placebo |
| buprenorphineAlso: 4 mg single doseParticipants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance. | Drug | sublingual tablet placebo |
| oral tablet placeboAlso: single doseParticipants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance. | Drug | hydrocodone, hydromorphone HCI, morphine sulfate, oxycodone |
| sublingual tablet placeboAlso: single doseParticipants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance. | Drug | buprenorphine |
Primary outcome
Pain detection
Time frame: 7 testing sessions over 12 weeks
Pain detection is defined as the number of seconds it takes for the participant to feel pain.
Pain tolerance
Time frame: 7 testing sessions over 12 weeks
Pain tolerance is defined as the number of seconds it takes before the participant removes his hand from the ice water.
1 secondary outcome
Pupillometry results
Time frame: 7 testing sessions over 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
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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.
Walter Ling, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing morphine sulfate, hydrocodone and hydromorphone HCI in people with Analgesic Response, run by University of California, Los Angeles 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 13 May 2014. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica Jenkins, MA (310-267-5318, jenkinsj@ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain detection (time frame: 7 testing sessions over 12 weeks). The study lists 2 primary outcomes in all. 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 13 May 2014.