An observational study in Buprenorphine and Pain, sponsored by Georgetown University. Terminated at 2 sites in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-03-21.
Sponsored by Georgetown University · 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.
Chronic pain impacts the daily lives of fully one-third of Americans over the age of 45, with prevalence expected to increase as the population ages. In well-intended and industry-driven efforts to provide relief to chronic pain sufferers, the prescription of opioids has increased dramatically since the turn of the century, such that it is currently estimated that between 5 and 8 million Americans use opioids on a daily basis for chronic pain management. Yet, prescription opioid therapy for chronic pain is not an evidence-based intervention. In fact, as evaluation data accumulate, it is becoming clear that outcomes are often poorer for patients on opioid therapy, and that improvements are appreciated when tapered off the medications. In the midst of an "epidemic of prescription drug abuse" it is critical that opioid prescription practices be evidence-based and delivered "in the best possible manner that maximizes effectiveness and minimizes harm".
A theorized explanation for poorer outcomes (functionality, quality of life) for patients on opioid therapy is the phenomenon of opioid-induced hyperalgesia (OIH). Well-demonstrated in animal and inferred in patients, ongoing opioid use results in increased sensitivity to experimental pain, which, in the case of the chronic pain patient, is believed to interfere with (if not preclude) desired pain relief outcomes. However, the causal relationship between opioid discontinuation and OIH has received little empirical attention, such that it is not clear the degree to which opioid taper improves pain responses and outcomes, if at all. Evidence supporting that prescription opioids makes the pain experience worse for chronic pain patients would support a sea change in current practice of chronic opioid therapy.
Studying the direct effects of an opioid taper on pain responses in chronic pain patients is challenging; complicated by the reemergence of pain, variable compliance with taper and concomitant increased use of non-opioid pain medications, a controlled examination of pain responses during and following opioid detoxification is not immediately tenable in this patient population. Thus, funded is a proof-of concept trial to identify and characterize the direct effects of opioid detoxification on experimental pain responses in opioid-dependent patients without chronic pain to establish if, in fact, a notable effect size can be discerned. If supported, these findings will provide a foundation upon which to predict efficacy in patients with the more complicated picture of chronic pain.
Specifically, in a well-characterized sample of men and women seeking addiction treatment in a residential setting, experimental pain responses will be serially described over the course of and for three months following a standard observed opioid (buprenorphine) taper, and compared to those of matched control patients initiated on buprenorphine maintenance therapy. Pain responses will be measured with two valid and reliable experimental pain induction techniques commonly used to measure OIH (cold-pressor, quantitative sensory testing), and subject-level predictors of response identified.
152 studies on the registry are indexed under Hyperalgesia; 13 are open to participants now.
This study's enrollment of 15 is below the median of 53 across 20 observational studies indexed under Hyperalgesia.
Browse Hyperalgesia studies →Georgetown University is the lead sponsor of 286 studies on the registry; 42 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Men and women seeking addiction treatment in a residential or outpatient setting
Exclusion Criteria:
Patients tapering off their buprenorphine treatment
Drug: Buprenorphine
Patients starting their buprenorphine treatment
Drug: Buprenorphine
Patients taking buprenorphine to wean off an opiate addiction
Also known as: Suboxone
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months
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.
Time frame: 3 months
Plan to share: No
This study is terminated, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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