Healthy VolunteersNCT00256347
Analgesic Tolerance to Repeated Doses of Subcutaneous Morphine
A study testing intramuscular injections of morphine in people with Healthy Volunteers, run by University of California, San Francisco at 1 site in United States.
Trial summary
30 healthy volunteers will be enrolled in this 6-session study. The first visit will be a screening/orientation session. The next 5 visits will be (full day) outpatient sessions taking place Monday through Friday during one week. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- intramuscular injections of morphine
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Dec 2006
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers who are 21-50 years of age,
- If female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device [IUD], hormonal birth control, or double barrier method [male condom, female condom, or diaphragm plus a spermicidal agent such as contraceptive foam, jelly or cream]).
- In stable health
- Must weigh between 110 and 200 lbs and have a Body Mass Index between 20 and 30.
- Able and willing to provide written informed consent
- Able to understand and follow the instructions of the investigator, including the pain intensity rating scales
- Develops temporary secondary hyperalgesia from the brief thermal sensitization stimulation procedure performed at the screening visit (Session 1)
- Opioid naïve (no previous history of long term opioid use)
Who cannot join
- Severe coronary artery disease, uncontrolled hypertension, cardiac ventricular conduction abnormalities, or orthostatic mean blood pressure drop > than 25 mmHg, severe chronic obstructive pulmonary disease.
- History of renal or hepatic failure.
- Evidence of hepatic, hematological, or renal dysfunction based on judgment of physician.
- Subjects receiving treatment with topical steroids in areas to be stimulated.
- Dermatopathology, skin hypersensitivity, or skin lesions in the area of measurements on the thigh and forearm.
- Allergy to opioids.
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- Concomitant treatment with anticonvulsants, antidepressants, NMDA blockers, muscle relaxants, sedatives, other psychotropic drugs or opioids.
- Is currently taking or has taken a monamine oxidase inhibitor (MAOI) drug within two weeks prior to study medication sessions.
- Use of NSAIDs or acetaminophen within 36 hours of drug treatment sessions and/or use of caffeine or alcohol beginning 24 hours prior to the first drug treatment sessions.
- Use of long-acting NSAIDs such as piroxicam or naproxen (Naprosyn) within 1 week of oral drug treatment sessions.
- Heat pain detection thresholds above 47°C/116.6°F on the arm (see below).
- Subjects who are not within following parameters for weight: between 110 and 200 pounds and between 20 and 30 using the Body Mass Index.
- Subjects who are unable to read or speak English.
- Diagnosis of insulin-requiring diabetes mellitus.
- Current diagnosis of drug or alcohol abuse or history of opioid drug abuse
- Use of opioids or alcohol while in study, confirmed by urine drug-screen at Session 1 and Session 2 and breathalyzer for alcohol at Sessions 2-6.
- Neurological dysfunction or psychiatric disorder severe enough to interfere with assessment of pain and sensory systems.
- Has received an investigational drug within 30 days prior to Study Visit 2 or is scheduled to receive another opioid medication during the course of this study.
- Chronic pain condition requiring regular physician visits and prescription medication use on a daily basis.
- Subjects who in the opinion of the investigator are considered unable to adhere to scheduled appointments, unlikely to comply with the study protocol, or who are unsuitable for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Analgesic Tolerance to Repeated Doses of Subcutaneous Morphine Using the Brief Thermal Sensitization Model in Healthy Volunteers
30 healthy volunteers will be enrolled in this 6-session study. The first visit will be a screening/orientation session. The next 5 visits will be (full day) outpatient sessions taking place Monday through Friday during one week. All full day visits will be drug administration sessions with subjects randomized to one of two groups. The primary purpose is to investigate the time course of development of analgesic tolerance (loss of pain relieving effect) to morphine on experimentally produced skin tenderness in healthy volunteers.
Read the detailed description
30 healthy volunteers will be enrolled in this 6-session study. The first visit will be a screening/orientation session. The next 5 visits will be (full day) outpatient sessions taking place Monday through Friday during one week. All full day visits will be drug administration sessions with subjects randomized to one of two groups. Group A will receive two daily intramuscular injections of 8 mg morphine on Monday through Thursday and two intramuscular injections of placebo on Friday. Group B will receive two daily intramuscular injections of placebo on Monday through Thursday and two intramuscular injections of 8 mg morphine on Friday. During the Monday through Friday sessions the painfulness of experimental heat application and the area of skin tenderness (primary and secondary hyperalgesia) will be assessed before and two times after the intramuscular injections. Heat will be applied by using a computer controlled probe that applies heat (450 C/1130 F) on the thigh for 3 minutes (Brief Thermal Sensitization model.)
- Conditions
- Healthy Volunteers
- Being tested
- intramuscular injections of morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intramuscular injections of morphineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the time course of development of analgesic tolerance (loss of pain relieving effect) to morphine on experimentally produced skin tenderness in healthy volunteers.
Secondary outcomes (1)
To expand the knowledge about the analgesic (pain relieving) effects of opioids on experimentally induced pain and further validate the Brief Thermal Sensitization model as a tool for testing analgesic drugs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startMar 2005
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Investigators
- Karin Petersen, MD, Principal investigator, University of California, San FranciscoMichael C Rowbotham, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256347
- Sponsor's protocol ID
- H5612-25135
- Other IDs
- H5612-25135
- Status last verified
- Mar 2011
- First submitted
- 16 Nov 2005
- Last updated
- 14 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Analgesic Tolerance to Repeated Doses of Subcutaneous Morphine Using the Brief Thermal Sensitization Model in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00256347
- Acronym / sponsor ID
- H5612-25135
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 21 Nov 2005 (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.
30 healthy volunteers will be enrolled in this 6-session study. The first visit will be a screening/orientation session. The next 5 visits will be (full day) outpatient sessions taking place Monday through Friday during one week. All full day visits will be drug administration sessions with subjects randomized to one of two groups. The primary purpose is to investigate the time course of development of analgesic tolerance (loss of pain relieving effect) to morphine on experimentally produced skin tenderness in healthy volunteers.
Detailed description
30 healthy volunteers will be enrolled in this 6-session study. The first visit will be a screening/orientation session. The next 5 visits will be (full day) outpatient sessions taking place Monday through Friday during one week. All full day visits will be drug administration sessions with subjects randomized to one of two groups. Group A will receive two daily intramuscular injections of 8 mg morphine on Monday through Thursday and two intramuscular injections of placebo on Friday. Group B will receive two daily intramuscular injections of placebo on Monday through Thursday and two intramuscular injections of 8 mg morphine on Friday. During the Monday through Friday sessions the painfulness of experimental heat application and the area of skin tenderness (primary and secondary hyperalgesia) will be assessed before and two times after the intramuscular injections. Heat will be applied by using a computer controlled probe that applies heat (450 C/1130 F) on the thigh for 3 minutes (Brief Thermal Sensitization model.)
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy volunteers who are 21-50 years of age,
- If female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device [IUD], hormonal birth control, or double barrier method [male condom, female condom, or diaphragm plus a spermicidal agent such as contraceptive foam, jelly or cream]).
- In stable health
- Must weigh between 110 and 200 lbs and have a Body Mass Index between 20 and 30.
- Able and willing to provide written informed consent
Key exclusion criteria (20 listed)
- Severe coronary artery disease, uncontrolled hypertension, cardiac ventricular conduction abnormalities, or orthostatic mean blood pressure drop > than 25 mmHg, severe chronic obstructive pulmonary disease.
- History of renal or hepatic failure.
- Evidence of hepatic, hematological, or renal dysfunction based on judgment of physician.
- Subjects receiving treatment with topical steroids in areas to be stimulated.
- Dermatopathology, skin hypersensitivity, or skin lesions in the area of measurements on the thigh and forearm.
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 |
|---|---|---|
| intramuscular injections of morphine | Drug | – |
Primary outcome
To investigate the time course of development of analgesic tolerance (loss of pain relieving effect) to morphine on experimentally produced skin tenderness in healthy volunteers.
1 secondary outcome
To expand the knowledge about the analgesic (pain relieving) effects of opioids on experimentally induced pain and further validate the Brief Thermal Sensitization model as a tool for testing analgesic drugs.
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 14 Apr 2011.
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Screening Protocol
Pain
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.
Karin Petersen, MD principal investigator
University of California, San Francisco
Michael C Rowbotham, MD 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 intramuscular injections of morphine in people with Healthy Volunteers, 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 8 inclusion and 20 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: finished, as of the sponsor's last update on 14 Apr 2011. 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?
To investigate the time course of development of analgesic tolerance (loss of pain relieving effect) to morphine on experimentally produced skin tenderness in healthy volunteers.. 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 14 Apr 2011.