No increased pain among opioid‐dependent individuals treated with extended‐release naltrexone or buprenorphine‐naloxone: A 3‐month randomized study and 9‐month open‐treatment follow‐up study

Abstract

Background and ObjectivesIt is presently unclear whether extended‐release naltrexone hydrochloride treatment induces pain or aggravates existing pain among individuals with opioid use disorders. We assessed changes in pain among individuals receiving treatment with either extended‐release naltrexone hydrochloride or buprenorphine‐naloxone hydrochloride.MethodsThis randomized prospective open‐label clinical study included 143 participants (aged 18–60 years) with opioid dependencies, recruited from outpatient addiction clinics at five urban hospitals in Norway. After in‐patient detoxification from opioids, patients were randomized to 12‐week treatment with either long‐acting naltrexone (380 mg intramuscularly injected every four weeks) or buprenorphine‐naloxone (flexible 4–16 mg sublingual doses daily). This phase was followed by a 9‐month open‐treatment study with the participant's choice of either naltrexone or buprenorphine‐naloxone. Changes in pain were assessed every 4 weeks using the Norwegian Short‐Form of McGill Pain Questionnaire.ResultsThroughout the study period, we found no increase in mean sensory pain, affective pain, or present pain intensity on the McGill Pain Questionnaire, in either treatment group, including the subgroups of participants with chronic pain. Participants who switched from buprenorphine‐naloxone to extended‐release naltrexone treatment after week 12 reported no increase in pain intensity during longer‐term treatment. Women experienced significantly more affective pain symptoms than men (p = .01).Discussion and ConclusionsAmong individuals with opioid use disorder, switching from daily opioid use to long‐acting naltrexone did not induce pain, or aggravate mild‐to‐moderate chronic pain.Scientific SignificanceIn opioid‐dependent individuals, mild‐to‐moderate chronic pain was not influenced by opioid agonist or antagonist treatment.Trial RegistrationClinicaltrials.gov #NCT01717963, first registered: Oct 28, 2012. Protocol version # 3C, June 12th 2012. (Am J Addict 2018;XX:1–9)

Adapting treatment length to opioid‐dependent individuals’ needs and preferences: a 2‐year follow‐up to a 1‐year study of extended‐release naltrexone

“…The mean age was 36 years, and 82% were men. Patients’ characteristics were representative of the full patient group enrolled into the parent study [ 12 , 26 , 38 , 40 , 41 ].…”

“…This prospective 2‐year cohort study was a prolonged follow‐up to a previous 3‐month randomized clinical trial comparing XR‐NTX with BP‐NLX [ 26 ] and a subsequent 9‐month follow‐up study of XR‐NTX [ 12 , 38 , 39 , 40 , 41 ]. At the conclusion of the 9‐month follow‐up study, participants were offered continued treatment with XR‐NTX up to a period of 104 weeks.…”

Alcohol and Pain: A Translational Review of Preclinical and Clinical Findings to Inform Future Treatment Strategies

“…Pharmacotherapy approaches that may be effective include those that target brain reward and stress systems. For example, there is preliminary evidence that naltrexone, a Food and Drug Administration–approved medication for AUD, may be effective in the treatment of chronic pain (Patten et al, ) and extended‐release naltrexone may be particularly useful in the treatment of co‐occurring chronic pain, AUD, and opioid use disorder (OUD) (Hartung et al, ; Korthuis et al, ; Latif et al, ). However, individuals with OUD need to be fully detoxified prior to naltrexone treatment and compliance with naltrexone treatment is a major issue.…”

The Predictive Value of Degree of Preference for Extended-Release Naltrexone for Treatment Adherence, Opioid Use, and Relapse

“…Participants who continue treatment might relapse in situations of intense temptation or periods of boredom, stress, or inability to cope with physical or emotional pain. However, our participants reported a significant reduction in insomnia symptoms, anxiety, and depression symptoms with both XR-NTX and BP-NLX [31], and the XR-NTX group did not report any increase in chronic pain [32]. The risk of relapse was more prominent in participants who were initially ambivalent about XR-NTX, and it is possible that over time the novelty of the treatment wore off, and that the ambivalence about abstinence became the reason for relapse.…”