The Effects of Opioid Taper on Opioid-Induced Hyperalgesia

Stopped early

Conditions studied: Buprenorphine, Pain

In brief

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.

Key facts

Study ID

NCT03063905

Run by

Georgetown University

People needed

15

Starts

2017-01-01

Expected to finish

2018-02-28

Last updated by the study team

2018-03-21

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Avery Road Treatment Center — Rockville, Maryland, United States
• Kolmac Clinic — Silver Spring, Maryland, United States

Full record on ClinicalTrials.gov

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