Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088296
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-07-23
Brief Title:
Effects of Osteoarthritis Pain Morphine and Placebo on Neuroendocrine Function in Men
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effects of Osteoarthritis Pain Morphine and Placebo on Neuro-Endocrine Function in Men
Status:
COMPLETED
Status Verified Date:
2007-10-18
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the effects of morphine on leuteinizing hormone testosterone adrenocorticotropic hormone and cortisol in men The use of long-term opioids such as morphine to treat patients with pain is increasing despite a dearth of information about their effects on hormones The study will also look at the effect of chronic pain on these hormone levels and the effect of placebo on pain
Men between 30 and 65 years of age who have had moderate to severe chronic pain due to osteoarthritis for at least 3 months and healthy pain-free men in the same age range may be eligible for this study Patients taking an opioid-based medication such as percocet vicodin or morphine for pain relief as well as patients who are not taking opioids may participate Candidates are screened with a medical history physical examination blood tests including a blood test to look for possible pain genes electrocardiogram x-ray and questionnaires that assess the impact of pain on functional level and psychological well being
This is a four-part study Healthy volunteers and patients who are taking opioids for their arthritis pain end their participation after Part I those who are not taking opioids continue with Parts II III and IV as follows
Part I Participants are admitted to the NIH Clinical Center at 4 pm for an overnight stay At 6 pm a catheter plastic tube is placed in a vein in the forearm and remains in place throughout the night Blood samples of 3 ccs each less than a teaspoon are collected through the catheter every 20 minutes for 12 hours from 8 pm until 8 am Participants also collect their urine starting from 8 am on the morning of hospital admission and continue the collection throughout their 24-hour hospital stay Patients are discharged at the completion of the blood sampling
Part II Patients are randomly assigned to take morphine MS Contin placebo or standard treatment which consists of anti-inflammatory medications and acetaminophen as needed but no opioids Patients in groups I and II are also permitted to take anti-inflammatory drugs and acetominophen in addition to their study medication Patients are monitored for drug side effects by phone twice a week and medication doses are adjusted as needed The morphine dose is gradually increased over a 4-week period if no side effects develop After 2 weeks on the highest dose of morphine hormone blood levels are measured and patients complete questionnaires Patients are readmitted to the hospital for a repeat blood sampling and blood collection as in Part I Patients on morphine and placebo are then gradually tapered off drug over 12 days and remain drug-free for 2 days before starting Part III
Part III All patients are given morphine in this part of the study and are monitored for drug side effects by phone twice a week with doses adjusted as needed The morphine is gradually increased over a 6-week period if no side effects develop and is maintained at the highest dose for another 8 weeks Hormone levels are measured and the blood and urine studies and questionnaires are repeated Patients interested in continuing long-term treatment with MC Contin are referred back to their physicians with recommendations to that effect
Part IV Patients are followed by phone for 6 months at which time they return to the Clinical Center for hormone level measurements repeat blood and urine tests and questionnaires
Men between 30 and 65 years of age who have had moderate to severe chronic pain due to osteoarthritis for at least 3 months and healthy pain-free men in the same age range may be eligible for this study Patients taking an opioid-based medication such as percocet vicodin or morphine for pain relief as well as patients who are not taking opioids may participate Candidates are screened with a medical history physical examination blood tests including a blood test to look for possible pain genes electrocardiogram x-ray and questionnaires that assess the impact of pain on functional level and psychological well being
This is a four-part study Healthy volunteers and patients who are taking opioids for their arthritis pain end their participation after Part I those who are not taking opioids continue with Parts II III and IV as follows
Part I Participants are admitted to the NIH Clinical Center at 4 pm for an overnight stay At 6 pm a catheter plastic tube is placed in a vein in the forearm and remains in place throughout the night Blood samples of 3 ccs each less than a teaspoon are collected through the catheter every 20 minutes for 12 hours from 8 pm until 8 am Participants also collect their urine starting from 8 am on the morning of hospital admission and continue the collection throughout their 24-hour hospital stay Patients are discharged at the completion of the blood sampling
Part II Patients are randomly assigned to take morphine MS Contin placebo or standard treatment which consists of anti-inflammatory medications and acetaminophen as needed but no opioids Patients in groups I and II are also permitted to take anti-inflammatory drugs and acetominophen in addition to their study medication Patients are monitored for drug side effects by phone twice a week and medication doses are adjusted as needed The morphine dose is gradually increased over a 4-week period if no side effects develop After 2 weeks on the highest dose of morphine hormone blood levels are measured and patients complete questionnaires Patients are readmitted to the hospital for a repeat blood sampling and blood collection as in Part I Patients on morphine and placebo are then gradually tapered off drug over 12 days and remain drug-free for 2 days before starting Part III
Part III All patients are given morphine in this part of the study and are monitored for drug side effects by phone twice a week with doses adjusted as needed The morphine is gradually increased over a 6-week period if no side effects develop and is maintained at the highest dose for another 8 weeks Hormone levels are measured and the blood and urine studies and questionnaires are repeated Patients interested in continuing long-term treatment with MC Contin are referred back to their physicians with recommendations to that effect
Part IV Patients are followed by phone for 6 months at which time they return to the Clinical Center for hormone level measurements repeat blood and urine tests and questionnaires
Detailed Description:
Several studies suggest that acceptance and use of opioid medicines for relief of chronic pain are increasing substantially and that opiodergic medications and chronic pain each perturb neuroendocrine functions especially those of the hypothalamic pituitary adrenal and gonadal axes The objectives of the proposed protocol entitled Effects of Chronic Musculoskeletal Pain and Opioidergic versus Placebo Interventions on Neuro-endocrine Function in Men are three fold
1 To determine whether long term opioid usage in men with chronic pain due to osteoarthritis results in abnormalities of ACTH cortisol LH and testosterone secretion
2 To evaluate whether placebo analgesia results in a similar hormonal response as elicited by an opioid analgesic Prior imaging studies have shown that placebo analgesia is associated with activation of similar parts of the cortex as with analgesic intake
3 To evaluate the effects of chronic pain per se on ACTH cortisol LH and testosterone secretion
To address these questions we propose a 4-part study In part I 12 healthy men will be compared with 12 men with chronic osteoarthritis OA pain on long term opioids and 12 narcotic naive men with chronic OA pain by means of 12 hour overnight frequent blood sampling for measurement of cortisol ACTH LH and testosterone
In part II 36 narcotic naive patients with chronic OA pain all of whom will have undergone overnight hormone sampling in Part I will be randomized to one of three treatment groups MS Contin 15-90 mg placebo and standard treatment
Doses of placebo and MS Contin will be escalated over 4 weeks in a similar fashion with two-week maintenance and 2 week taper At the end of maintenance at 6 weeks all patients will return for repeat 12 hour frequent sampling of the same hormones as in Part I At the end of part II patients will be invited to go on to an open label treatment period with MS Contin 15-120 mg in part III of the study which will consist of 6-week dose escalation and 8 weeks maintenance At that point patients will be referred back to their physicians with recommendations for continued treatment with MS Contin if patients are interested in this option
Patients will be followed by phone for 6 months At that point they will be asked to return to clinic for part IV an outpatient AM sample of testosterone LH ACTH and cortisol The primary endpoints of this study will be measures of LH testosterone ACTH and cortisol secretion whereas the secondary endpoints will be neurobehavioral indices such as pain and bothersomeness on visual analog scales the Oswestry Disability Index Multidimensional Pain Inventory and the Beck Depression Inventory It is anticipated that this study will provide novel information regarding the effects of chronic musculoskeletal pain and treatment with opioids versus placebo on selected neuroendocrine functions in men
1 To determine whether long term opioid usage in men with chronic pain due to osteoarthritis results in abnormalities of ACTH cortisol LH and testosterone secretion
2 To evaluate whether placebo analgesia results in a similar hormonal response as elicited by an opioid analgesic Prior imaging studies have shown that placebo analgesia is associated with activation of similar parts of the cortex as with analgesic intake
3 To evaluate the effects of chronic pain per se on ACTH cortisol LH and testosterone secretion
To address these questions we propose a 4-part study In part I 12 healthy men will be compared with 12 men with chronic osteoarthritis OA pain on long term opioids and 12 narcotic naive men with chronic OA pain by means of 12 hour overnight frequent blood sampling for measurement of cortisol ACTH LH and testosterone
In part II 36 narcotic naive patients with chronic OA pain all of whom will have undergone overnight hormone sampling in Part I will be randomized to one of three treatment groups MS Contin 15-90 mg placebo and standard treatment
Doses of placebo and MS Contin will be escalated over 4 weeks in a similar fashion with two-week maintenance and 2 week taper At the end of maintenance at 6 weeks all patients will return for repeat 12 hour frequent sampling of the same hormones as in Part I At the end of part II patients will be invited to go on to an open label treatment period with MS Contin 15-120 mg in part III of the study which will consist of 6-week dose escalation and 8 weeks maintenance At that point patients will be referred back to their physicians with recommendations for continued treatment with MS Contin if patients are interested in this option
Patients will be followed by phone for 6 months At that point they will be asked to return to clinic for part IV an outpatient AM sample of testosterone LH ACTH and cortisol The primary endpoints of this study will be measures of LH testosterone ACTH and cortisol secretion whereas the secondary endpoints will be neurobehavioral indices such as pain and bothersomeness on visual analog scales the Oswestry Disability Index Multidimensional Pain Inventory and the Beck Depression Inventory It is anticipated that this study will provide novel information regarding the effects of chronic musculoskeletal pain and treatment with opioids versus placebo on selected neuroendocrine functions in men
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-AT-0239 | None | None | None |