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The original PI (David Siegel) Left the VA
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| Name | Class |
|---|---|
| Solvay Pharmaceuticals | INDUSTRY |
The purpose of this pilot study is to test the effects of testosterone replacement on pain, fatigue, mood, cognition and libido in hypogonadal men on long-term opioid therapy for chronic pain.
Opioids are increasingly used for the treatment of non-malignant chronic pain with as many as five to ten million patients treated at the time of the most recent estimate in 2002. The side effects of opioids such as fatigue, loss of libido, Impaired cognition and sexual dysfunction have long been recognize and strikingly, resemble symptoms of hypogonadism in men. Many studies have demonstrated a high prevalence of hypogonadism in male subjects who are long-term users of opioids. The aims of this pilot study are, in hypogonadal men being treated with opioids for chronic pain, to: 1) determine the effect of TRT on pain; 2) determine effects of TRT on fatigue; 3) determine the effect of TRT on mood; 4) determine effects of TRT on cognition and 5) characterize the effects of TRT on sexual dysfunction. This study is a randomized, placebo-controlled, 6-week pilot study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone Gel | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| • To determine if testosterone replacement can improve pain control in opioid-treated, hypogonadal men with chronic pain. |
| Measure | Description | Time Frame |
|---|---|---|
| In opioid-treated, hypogonadal men with chronic pain, to determine whether testosterone replacement therapy (TRT) will: | ||
| reduce the opioid requirement. | ||
| improve fatigue |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher P Cardozo, M.D. | James J. Peters VAMC | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | American Pain Society, Guidelines for the Management of Acute and Cancer Pain. 4 ed. 1999, Glenview, IL: American Pain Society. | ||
| 8869456 | Background | Portenoy RK. Opioid therapy for chronic nonmalignant pain: a review of the critical issues. J Pain Symptom Manage. 1996 Apr;11(4):203-17. doi: 10.1016/0885-3924(95)00187-5. | |
| Background | Rigoni, G. Drug Utilization for Immediate- and Modified Release Opioids in the U.S. in FDA Anesthesia, Life Support, and Addiction Drug Products Advisory Committee. 2003. Gaithersburg, Maryland. | ||
| 14609780 |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D007006 | Hypogonadism |
| D003863 | Depression |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006058 | Gonadal Disorders |
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| improve depression |
| improve sexual function. |
| Improve cognition |
| To determine the proportion of responders to the analgesic effects of TRT |
| Background |
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| D004700 | Endocrine System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |