The Effects of Opioid Taper on Opioid-Induced Hyperalgesia

NCT03063905 | Terminated

• 2 other identifiers: 2016-0028U01DA029580
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Buprenorphine; Pain

Keywords

Opioid related disorders; Narcotic abuse

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• Improvement in opioid taper

  3 months

Study Arms (2)

Opioid Taper

Patients tapering off their buprenorphine treatment

Drug: Buprenorphine

Opioid Maintenance

Patients starting their buprenorphine treatment

Drug: Buprenorphine

Interventions

Buprenorphine DRUG

Patients taking buprenorphine to wean off an opiate addiction

Also known as: Suboxone

Opioid Maintenance; Opioid Taper

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Men and women seeking addiction treatment in a residential or outpatient setting

You may qualify if:

• between ages of 18-50
• able to provide a positive urine toxicology test for heroin, morphine and/or methadone (and free of other drugs of abuse) upon treatment admission
• without known background disease, including chronic or acute pain
• otherwise in good physical and mental health, or in the care of a physician who is willing to take responsibility for such treatment
• 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

You may not qualify if:

• meet diagnostic criteria for an active substance use disorder other than opioids and nicotine
• be acutely psychotic, severely depressed, and/or in need of inpatient psychiatric treatment
• have a neurological (i.e. Raynaud's syndrome or symptomatic cold neuropathy) or psychiatric illness that would affect pain responses
• 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.
• 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

Sponsors & Collaborators

• Georgetown University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Avery Road Treatment Center

Rockville, Maryland, 20853, United States

Location

Kolmac Clinic

Silver Spring, Maryland, 20910, United States

Location

Related Publications (16)

• 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.

  PMID: 20797916 BACKGROUND

• 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. Evid Rep Technol Assess (Full Rep). 2014 Sep;(218):1-219. doi: 10.23970/AHRQEPCERTA218.

  PMID: 30313000 BACKGROUND

• 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.

  PMID: 24315147 BACKGROUND

• 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. doi: 10.3822/ijtmb.v8i3.295. eCollection 2015 Sep.

  PMID: 26388962 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 24217469 BACKGROUND

• 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.

  BACKGROUND

• Silverman SM. Opioid induced hyperalgesia: clinical implications for the pain practitioner. Pain Physician. 2009 May-Jun;12(3):679-84.

  PMID: 19461836 BACKGROUND

• 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.

  PMID: 22983894 BACKGROUND

• Angst MS, Clark JD. Opioid-induced hyperalgesia: a qualitative systematic review. Anesthesiology. 2006 Mar;104(3):570-87. doi: 10.1097/00000542-200603000-00025.

  PMID: 16508405 BACKGROUND

• Mao J. Opioid-induced abnormal pain sensitivity: implications in clinical opioid therapy. Pain. 2002 Dec;100(3):213-217. doi: 10.1016/S0304-3959(02)00422-0. No abstract available.

  PMID: 12467992 BACKGROUND

• 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. doi: 10.1016/s0885-3924(00)00191-3.

  PMID: 11027904 BACKGROUND

• 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. doi: 10.1016/s0376-8716(00)00200-3.

  PMID: 11376918 BACKGROUND

• 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. doi: 10.1016/s0304-3959(00)00391-2.

  PMID: 11166974 BACKGROUND

• 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.

  PMID: 23398230 BACKGROUND

• 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. doi: 10.1016/j.drugalcdep.2005.09.007. Epub 2005 Oct 17.

  PMID: 16229972 BACKGROUND

MeSH Terms

Conditions

Pain; Opioid-Related Disorders; Narcotic-Related Disorders

Interventions

Buprenorphine; Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Naloxone; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Peggy Compton, RN, PhD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 24, 2017
• Study Start: January 1, 2017
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: March 21, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)