Chronic Low Back PainPhase 4NCT00246532
Opiate-Induced Tolerance & Hyperalgesia in Pain Patients
A Phase 4 study testing Morphine in people with Chronic Low Back Pain and Opioid-induced Hyperalgesia, run by National Institute of General Medical Sciences (NIGMS) at 1 site in United States.
Trial summary
Opiates such as morphine are the cornerstone medications for the treatment of moderate to severe pain. Recent evidence suggests that pain patients on chronic opioid therapy become more sensitive to pain (hyperalgesia) over time. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Low Back Pain, Opioid-induced Hyperalgesia
- What is being tested?
- Morphine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Aug 2009
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- opioid naïve (or less than 4 vicodin equiv/day)
- 18-70 years old
- candidate for opioid therapy for nonmalignant pain.
Who cannot join
- history of substance abuse or severe psychiatric disease
- use of medications for the treatment of neuropathic pain as these may alter tolerance or hyperalgesia
- neurological conditions interfering with experimental pain testing, e.g. severe peripheral neuropathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94025
About this study
Opiates such as morphine are the cornerstone medications for the treatment of moderate to severe pain. Recent evidence suggests that pain patients on chronic opioid therapy become more sensitive to pain (hyperalgesia) over time. There is also a long-standing notion that analgesic tolerance to opioids (habituation) develops during chronic use even though this phenomenon has never been prospectively studied. Our specific aims propose to prospectively test the hypotheses that; 1) Pain patients on chronic opioid therapy develop dose-dependent tolerance and/or hyperalgesia to these medications over time, 2) Opioid-induced tolerance and hyperalgesia develop differently with respect to various types of pain, 3) Opioid-induced hyperalgesia occurs independently of withdrawal phenomena, and 4) Opioid-induced tolerance and hyperalgesia develop differently based on gender and/or ethnicity. This proposed study will be the first quantitative and prospective study of tolerance and hyperalgesia in pain patients and will have important implications for the rational use of opioids in the treatment of chronic pain.
- Conditions
- Chronic Low Back Pain, Opioid-induced Hyperalgesia
- Being tested
- Morphine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Patients will be given morphine sulfate oral medication until their back pain is adequately controlled.
PlaceboDrug
Patients will receive placebo tablets.
| Study group | Role | What they receive |
|---|---|---|
| 1: Placebo Pill | Placebo comparator | This arm contains placebo medication. Receives: Drug: Placebo |
| 2: Morphine | Active comparator | Patients will receive oral morphine therapy. Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Tolerance
Measured: 1 month
Pain Threshold
Measured: 1 month
Secondary outcomes (5)
Opioid Titration
Measured: 1 month
Pain Intensity
Measured: 1 month
Roland-Morris Disability Index
Measured: 1 month
Beck Depression Inventory
Measured: 1 month
Follow-Up Survey
Patients were asked about their average pain levels and current medication usage
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionDec 2008
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of General Medical Sciences (NIGMS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Dr. Lawrence Chu, Stanford University
- Investigators
- Lawrence F Chu, MD, MS, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00246532
- Sponsor's protocol ID
- 5K23GM071400-02
- Other IDs
- 5K23GM071400-02
- Status last verified
- Apr 2012
- First submitted
- 26 Oct 2005
- Last updated
- 30 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opiate-Induced Tolerance & Hyperalgesia in Pain Patients
- ClinicalTrials.gov ID
- NCT00246532
- Acronym / sponsor ID
- 5K23GM071400-02
- Conditions
- Chronic Low Back Pain, Opioid-induced Hyperalgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- National Institute of General Medical Sciences (NIGMS)US National Institutes of Health
- Study start
- Oct 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 31 Oct 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.
Opiates such as morphine are the cornerstone medications for the treatment of moderate to severe pain. Recent evidence suggests that pain patients on chronic opioid therapy become more sensitive to pain (hyperalgesia) over time. There is also a long-standing notion that analgesic tolerance to opioids (habituation) develops during chronic use even though this phenomenon has never been prospectively studied. Our specific aims propose to prospectively test the hypotheses that; 1) Pain patients on chronic opioid therapy develop dose-dependent tolerance and/or hyperalgesia to these medications over time, 2) Opioid-induced tolerance and hyperalgesia develop differently with respect to various types of pain, 3) Opioid-induced hyperalgesia occurs independently of withdrawal phenomena, and 4) Opioid-induced tolerance and hyperalgesia develop differently based on gender and/or ethnicity. This proposed study will be the first quantitative and prospective study of tolerance and hyperalgesia in pain patients and will have important implications for the rational use of opioids in the treatment of chronic pain.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Placebo Pill | Placebo comparator | Drug: PlaceboThis arm contains placebo medication. |
| 2: Morphine | Active comparator | Drug: MorphinePatients will receive oral morphine therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- opioid naïve (or less than 4 vicodin equiv/day)
- 18-70 years old
- candidate for opioid therapy for nonmalignant pain.
Key exclusion criteria (3 listed)
- history of substance abuse or severe psychiatric disease
- use of medications for the treatment of neuropathic pain as these may alter tolerance or hyperalgesia
- neurological conditions interfering with experimental pain testing, e.g. severe peripheral neuropathy
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 |
|---|---|---|
| MorphinePatients will be given morphine sulfate oral medication until their back pain is adequately controlled. | Drug | 2: Morphine |
| PlaceboPatients will receive placebo tablets. | Drug | 1: Placebo Pill |
Primary outcome
Pain Tolerance
Time frame: 1 month
Pain Threshold
Time frame: 1 month
5 secondary outcomes
Opioid Titration
Time frame: 1 month
Pain Intensity
Time frame: 1 month
Roland-Morris Disability Index
Time frame: 1 month
Beck Depression Inventory
Time frame: 1 month
Follow-Up Survey
Time frame: 1 year
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 30 Apr 2012.
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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.
Lawrence F Chu, MD, MS principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Morphine in people with Chronic Low Back Pain and Opioid-induced Hyperalgesia, run by National Institute of General Medical Sciences (NIGMS) 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 3 inclusion and 3 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 30 Apr 2012. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Tolerance (time frame: 1 month). 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 30 Apr 2012.