Pain Clinical Trial
Official title:
The Effects of Opioid Taper on Opioid-Induced Hyperalgesia
Verified date | March 2018 |
Source | Georgetown University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Evidence to support the effectiveness of ongoing opioid therapy for the treatment of chronic non-malignant pain is lacking. In fact, data suggest that patient outcomes improve when tapered off opioid analgesics. To better understand the role opioid therapy plays in the experience of pain, we will study measured pain sensitivity in opioid dependent patients over the course of and 3 months following a standardized opioid taper. By isolating the effect of opioid taper in patients without pain, preliminary evidence of effect size can be used to guide clinicians treating patients with chronic pain.
Status | Terminated |
Enrollment | 15 |
Est. completion date | February 28, 2018 |
Est. primary completion date | February 28, 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: 1. between ages of 18-50 2. able to provide a positive urine toxicology test for heroin, morphine and/or methadone (and free of other drugs of abuse) upon treatment admission 3. without known background disease, including chronic or acute pain 4. otherwise in good physical and mental health, or in the care of a physician who is willing to take responsibility for such treatment 5. able to understand the purpose and instructions of the study, and provide informed consent as approved by the Western and Georgetown University Institutional Review Boards Exclusion Criteria: 1. meet diagnostic criteria for an active substance use disorder other than opioids and nicotine 2. be acutely psychotic, severely depressed, and/or in need of inpatient psychiatric treatment 3. have a neurological (i.e. Raynaud's syndrome or symptomatic cold neuropathy) or psychiatric illness that would affect pain responses 4. have a history of heart disease, stroke, or a pacemaker or uncontrolled high blood pressure. Good cardiovascular health is stipulated to ensure subjects can tolerate the sympathetic nervous system responses associated with the pain induction procedures. 5. have sensory deficits at pain testing site resulting from medical conditions such as diabetes, alcoholic neuropathy, AIDS neuropathy, severe thyroid, and liver or kidney diseases |
Country | Name | City | State |
---|---|---|---|
United States | Avery Road Treatment Center | Rockville | Maryland |
United States | Kolmac Clinic | Silver Spring | Maryland |
Lead Sponsor | Collaborator |
---|---|
Georgetown University | National Institute on Drug Abuse (NIDA) |
United States,
Angst MS, Clark JD. Opioid-induced hyperalgesia: a qualitative systematic review. Anesthesiology. 2006 Mar;104(3):570-87. Review. — View Citation
Brush DE. Complications of long-term opioid therapy for management of chronic pain: the paradox of opioid-induced hyperalgesia. J Med Toxicol. 2012 Dec;8(4):387-92. doi: 10.1007/s13181-012-0260-0. Review. — View Citation
Chou R, Deyo R, Devine B, Hansen R, Sullivan S, Jarvik JG, Blazina I, Dana T, Bougatsos C, Turner J. The Effectiveness and Risks of Long-Term Opioid Treatment of Chronic Pain. Evidence Report/Technology Assessment No. 218. (Prepared by the Pacific Northwest Evidence-based Practice Center under Contract No. 290-2012-00014-I.) AHRQ Publication No. 14-E005-EF. Rockville, MD: Agency for Healthcare Research and Quality; September 2014. www.effectivehealthcare.ahrq.gov/reports/final.cfm.
Compton P, Charuvastra VC, Kintaudi K, Ling W. Pain responses in methadone-maintained opioid abusers. J Pain Symptom Manage. 2000 Oct;20(4):237-45. — View Citation
Compton P, Charuvastra VC, Ling W. Pain intolerance in opioid-maintained former opiate addicts: effect of long-acting maintenance agent. Drug Alcohol Depend. 2001 Jul 1;63(2):139-46. — View Citation
Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on Research Standards for Chronic Low Back Pain. Int J Ther Massage Bodywork. 2015 Sep 1;8(3):16-33. eCollection 2015 Sep. — View Citation
Doverty M, White JM, Somogyi AA, Bochner F, Ali R, Ling W. Hyperalgesic responses in methadone maintenance patients. Pain. 2001 Feb 1;90(1-2):91-6. — View Citation
Executive Office of the President of the United States of America. (2011). Epidemic: Responding to America's Prescription Drug Abuse. Retrieved January 18, 2016, from White House Website: https://www.whitehouse.gov/sites/default/files/ondcp/policy-and-research/rx_abuse_plan.pdf.
Eyler EC. Chronic and acute pain and pain management for patients in methadone maintenance treatment. Am J Addict. 2013 Jan;22(1):75-83. doi: 10.1111/j.1521-0391.2013.00308.x. Review. — View Citation
Johannes CB, Le TK, Zhou X, Johnston JA, Dworkin RH. The prevalence of chronic pain in United States adults: results of an Internet-based survey. J Pain. 2010 Nov;11(11):1230-9. doi: 10.1016/j.jpain.2010.07.002. Epub 2010 Aug 25. — View Citation
Mao J. Opioid-induced abnormal pain sensitivity: implications in clinical opioid therapy. Pain. 2002 Dec;100(3):213-7. Review. — View Citation
Nuckols TK, Anderson L, Popescu I, Diamant AL, Doyle B, Di Capua P, Chou R. Opioid prescribing: a systematic review and critical appraisal of guidelines for chronic pain. Ann Intern Med. 2014 Jan 7;160(1):38-47. doi: 10.7326/0003-4819-160-1-201401070-00732. Review. — View Citation
Pud D, Cohen D, Lawental E, Eisenberg E. Opioids and abnormal pain perception: New evidence from a study of chronic opioid addicts and healthy subjects. Drug Alcohol Depend. 2006 May 20;82(3):218-23. Epub 2005 Oct 17. — View Citation
Silverman SM. Opioid induced hyperalgesia: clinical implications for the pain practitioner. Pain Physician. 2009 May-Jun;12(3):679-84. Review. — View Citation
The Management of Opioid Therapy for Chronic Pain Working Group. (2010). VA/DOD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain. Dept of Veterans Affairs, Department of Defense.
Von Korff MR. Long-term use of opioids for complex chronic pain. Best Pract Res Clin Rheumatol. 2013 Oct;27(5):663-72. doi: 10.1016/j.berh.2013.09.011. Epub 2013 Oct 5. Review. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Threshold Response (in seconds) - Cold Pressor Test | To compare the effects of opioid taper with initiating buprenorphine maintenance therapy by undergoing experimentally induced cold-pressor test (measured in seconds). Cold pain threshold responses will be compared within-subject in the taper group and between the two groups. | 3 months | |
Primary | Pain Tolerance Response (in seconds) - Cold Pressor Test | To compare the effects of opioid taper with initiating buprenorphine maintenance therapy by undergoing experimentally induced cold-pressor test (measured in seconds). Cold pain tolerance responses will be compared within-subject in the taper group and between the two groups. | 3 months | |
Primary | Pain Threshold Response (in seconds) - Quantitative Sensory Test | To compare the effects of opioid taper with initiating buprenorphine maintenance therapy by undergoing experimentally induced quantitative sensory test pain (measured in seconds). Heat pain threshold responses will be compared within-subject in the taper group and between the two groups. | 3 months | |
Primary | Pain Tolerance Response (in seconds) - Quantitative Sensory Test | To compare the effects of opioid taper with initiating buprenorphine maintenance therapy by undergoing experimentally induced quantitative sensory test pain (measured in seconds). Heat pain tolerance responses will be compared within-subject in the taper group and between the two groups. | 3 months | |
Secondary | Improvement in opioid taper | A sub-aim of the project is to study how the degree of improvement related to opioid taper in experimental pain responses is related to socio-demographic, psychological, and opioid use history characteristic of the subject. | 3 months |
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