Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01559454 |
| Other study ID # |
FMD0600908A |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
February 2012 |
| Est. completion date |
May 2014 |
Study information
| Verified date |
October 2020 |
| Source |
State University of New York at Buffalo |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Chronic pain patients are treated with prescription opioids and many exhibit opioid
addiction. Currently, there are no evidence-based guidelines to better manage patients with
chronic pain and coexistent opioid addiction. This study compares 6-months buprenorphine and
methadone treatment in these patients. The investigators hypothesize that both buprenorphine
and methadone treatment will reduce pain and addiction behaviors and increase functioning in
these patients.
Description:
Chronic non-malignant pain (i.e. pain unrelated to cancer that persists beyond the usual
course of disease or injury) is a major concern in the United States. Opioids are the most
commonly prescribed medication to treat patients with chronic non-malignant pain. However, in
one systematic review of chronic low back pain, the authors note that, although clinical
trials suggest that opioids are effective for short-term use (≤ 16 weeks), the effectiveness
of long-term opioids (> 16 weeks) for pain relief and improved physical functioning is less
clear.
Five to 31 percent of chronic back pain patients prescribed long-term opioids show aberrant
drug-taking behaviors. Many develop tolerance and withdrawal, 43% of these patients exhibit
opioid addiction. Therefore, patients with chronic pain and a co-occurring opioid addiction
present a clinical challenge. In such cases, referral to addiction experts is recommended,
but specialized treatment is currently based on expert opinion and observational studies.
The expert recommendation is detoxification followed by treatment with methadone,
buprenorphine, naltrexone, or non-opioid analgesics in conjunction with behavioral
counseling. Discontinuing short-acting opioid medications increases pain and will make it
difficult for these patients to abstain from opioids due to the severity of pain. However,
continuing these opioid medications worsens their addiction and renders opioids ineffective
in the treatment of pain. Research is needed to compare the various medication-assisted
treatments.
Long-acting opioids (e.g., methadone, buprenorphine) are used to replace treatment with
short-acting opioids (e.g., hydrocodone, oxycodone). Methadone is a full mu-opioid-receptor
agonist that can be effective in treating pain. Two small studies suggest that treatment of
patients with chronic pain and co-occurring substance use disorder with methadone and
adjunctive pain management therapy is superior to non-opioid treatment protocols. Despite the
demonstration that methadone can be effective as both an analgesic and for opioid addiction
treatment, it possesses side effects (e.g, constipation) and serious adverse events (e.g,
respiratory depression, risk of overdose) that limit its use, making physicians reluctant to
prescribe methadone.
Buprenorphine, a partial opioid agonist, is an alternative to methadone for treatment of
opioid addiction, has a safety profile superior to methadone, and possesses analgesic
properties. For outpatient use, buprenorphine is combined with naloxone (BUP/NLX) to reduce
the potential for abuse (i.e., IV administration). When given to those who abuse prescription
opioids BUP/NLX possesses better treatment outcomes than those who abuse heroin. In one
uncontrolled case series of 95 participants, Malinoff and his colleagues concluded that the
effectiveness in the treatment of opioid dependence, in providing analgesia, and the low
abuse liability make BUP/NLX a potentially useful treatment for patients with chronic pain
and co-occurring opioid addiction. In a randomized controlled trial by Blondell et al.
(2010), treatment with BUP/NLX was superior to the abstinence-oriented approach in regards to
treatment retention in patients with chronic pain and co-existent opioid addiction. However,
there has not been a randomized clinical trial comparing BUP/NLX with methadone maintenance
in chronic pain patients with opioid addiction. Preliminary data suggest that both 6-months
BUP/NLX and methadone treatment results analgesia, but methadone treatment results in better
addiction outcomes. The present study is designed to determine the complexity of recovery
outcomes (e.g., functioning, mental health) in chronic pain patients. Clinicians need
evidence-based guidelines to more effectively manage patients who have both chronic pain and
evidence of opioid misuse or addiction behaviors.
In this study, we plan to investigate whether patients treated with BUP/NLX and usual care
will have improved clinical outcomes as those provided with methadone treatment and usual
care. Specifically, we propose to give 63 patients BUP/NLX therapy for 6 months (experimental
group) and 63 patients methadone therapy over 6 (active comparator). We hypothesize that
patients given BUP/NLX treatment will have similar outcomes as those receiving methadone
maintenance with respect to functioning, mental health, pain level, and treatment retention.
