The impact of long-term maintenance treatment with buprenorphine on complex psychomotor and cognitive function

Shmygalev, S.; Damm, Martin; Weckbecker, Klaus; Berghaus, Günter; Petzke, Frank; Sabatowski, Rainer

doi:10.1016/j.drugalcdep.2011.01.017

Cited by 33 publications

(24 citation statements)

References 33 publications

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“…In contrast to many other studies, and following the recommendations of some authors [47], the effect of alcohol was used in our study as a “real-world” endpoint and an important benchmark for clinical relevance, as its impact on complex psychomotor performance is well documented and quantifiable. The blood alcohol concentration of 0.05% blood alcohol was chosen as a benchmark according to the German legislation and previous studies [15, 19, 22, 34]. From this perspective, the current results indicated that irrespective of the levels of individual symptomatology and severity, patients with FMS as a group did not perform worse than the normal population under the influence of a 0.05% blood alcohol level.…”

Section: Discussionmentioning

confidence: 55%

“…In accordance with prior studies from our group with patients on acute and chronic opioid therapy [15, 19, 20, 22, 51], we used 1:3 randomizations to increase the power of the study. With 43 patients and 129 controls, the power of this study was calculated to be close to 1 (one-sided t test, α = 0.05).…”

Section: Methodsmentioning

confidence: 99%

“…Driving ability can be compromised if one or more of the aspects involved in cognitive and psychomotor functions, such as attention, reaction time, visual orientation, perception, vigilance, and motor coordination, are impaired [15, 19, 20, 22]. To assess all of these factors, a battery of tests and statistical analyses complying with international recommendations, as well as with German legislation, were applied [28–33].…”

Section: Introductionmentioning

confidence: 99%

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Assessing Cognitive and Psychomotor Performance in Patients with Fibromyalgia Syndrome

Shmygalev

Dagtekin²,

Gerbershagen

et al. 2014

Pain Ther

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IntroductionPatients with fibromyalgia syndrome (FMS) generally present with chronic widespread pain, accompanied by a range of additional and non-specific symptoms, such as fatigue, disturbed sleep, and cognitive dysfunction, which tend to increase with overall severity. Previous studies have shown moderate cognitive impairment in patients with FMS, but there are few valid data explicitly assessing the relevance of these findings to everyday functions, such as driving ability. Therefore, we studied patients with FMS to assess the impact of FMS on tests that predict driving ability.MethodsFemale patients with FMS were prospectively compared to a historical control group of healthy volunteers. The test battery comprised assessments of visual orientation, concentration, attention, vigilance, motor coordination, performance under stress, and reaction time.ResultsA total of 43 patients were matched to 129 controls. The results indicated that the patients’ psychomotor and cognitive performances were significantly non-inferior when compared to healthy controls (with 0.05% alcohol), with the exception of motor coordination. Patients and healthy controls showed an age-related decline in test performance. Correlations were smaller in patients and reversed for vigilance which was linked to a greater FMS symptom load in younger patients.ConclusionThe results of the present study demonstrate that, in general, the driving ability of patients with FMS was not inferior to that of healthy volunteers based on a standardized computer-based test battery. However, variables, such as younger age, depression, anxiety, fatigue, pain, and poor motor coordination, likely contribute to the subjective perception of cognitive dysfunction in FMS.Electronic supplementary materialThe online version of this article (doi:10.1007/s40122-014-0028-0) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 55%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Assessing Cognitive and Psychomotor Performance in Patients with Fibromyalgia Syndrome

Shmygalev

Dagtekin²,

Gerbershagen

et al. 2014

Pain Ther

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“…Due to its partial agonism at MORs, BPN is considered safer than other opiates because it produces fewer side effects, has a ceiling effect on respiratory depression and is not immunosuppressive compared to other potent MOR agonists like morphine or heroin (Davis 2012). Moreover, opioid-dependent patients show milder withdrawal symptoms, less drug dependence, and fewer or no cognitive deficits when treated with BPN (Shmygalev et al 2011; Davis 2012). In a limited number of clinical studies, BPN has also been shown to produce antidepressant effects in non-opioid dependent treatment-resistant patients (Bodkin et al 1995; Nyhuis et al 2008; Karp et al 2014).…”

Section: Introductionmentioning

confidence: 99%

Effects of buprenorphine on behavioral tests for antidepressant and anxiolytic drugs in mice

et al. 2014

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Rationale Buprenorphine (BPN) has been shown to rapidly improve mood in treatment-resistant depressed patients in small clinical studies. However, BPN’s effects in preclinical tests for mood and antidepressant efficacy are largely unexplored. Objective The current study examined the effects of BPN in the forced swim test (FST) and novelty-induced hypophagia (NIH) test as measures of antidepressant and anxiolytic-like effects in C57BL/6J mice. Microdialysis was used to measure whether BPN engaged KORs in the nucleus accumbens shell (NAcSh) at a behaviorally active dose (0.25 mg/kg). Methods BPN was tested in the FST at both 30 min and 24 h post administration. Also measured in the FST at 24 h post administration were the KOR antagonist norbinaltorphimine (nor-BNI), the MOR agonist morphine and the reference antidepressant desipramine. The anxiolytic effects of BPN were examined in the NIH test 24 h after treatment. The effects of acute injection of BPN and the KOR agonist U50,488 were measured on extracellular DA levels in the NAcSh. Results BPN produced significant reductions in FST immobility without changing locomotor activity and reduced approach latencies in the novel environment of the NIH test when tested 24 h after treatment. Repeated daily BPN injections for 6 d did not produce tolerance to these behavioral effects. nor-BNI produced a similar antidepressant-like response in the FST 24 h postinjection but morphine and desipramine were ineffective. BPN (0.25 mg/kg) did not alter DA levels when given alone but prevented the KOR agonist U50,488 from reducing DA levels. Conclusions Acute and subchronic treatment with BPN produced antidepressant and anxiolytic-like responses in mice at doses that engage KORs. These studies support the clinical evidence that BPN may be a novel rapid-acting antidepressant medication and provides rodent models for investigating associated neurochemical mechanisms.

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“…Unlike comparable trials of strong opioids [9, 21, 25], this trial did not compare patients receiving tapentadol with a group of historical controls consisting of untreated healthy subjects. The Vienna Test System-Traffic Plus can use a reference population for internal comparison; because the test system has been validated against a standard driving test [21], no comparative arm was required.…”

Section: Statistical Analysesmentioning

confidence: 99%

Driving Ability in Patients with Severe Chronic Low Back or Osteoarthritis Knee Pain on Stable Treatment with Tapentadol Prolonged Release: A Multicenter, Open-label, Phase 3b Trial

et al. 2014

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IntroductionStrong centrally acting analgesics, including tapentadol prolonged release (PR), have demonstrated efficacy for the management of non-malignant, chronic pain. Maintaining patient independence, including the ability to drive safely, is a key goal of long-term analgesic therapy. This multicenter, open-label, phase 3b trial evaluated the effects of tapentadol PR on driving ability.MethodsThis study included patients who had completed previous tapentadol PR trials for severe low back or osteoarthritis pain. After at least 6 weeks of dose stability, patients continued taking tapentadol PR (50–250 mg twice daily) and could take supplemental immediate-release tapentadol 50 mg, except on the day before or day of the driving test (before the test). Pain intensity was assessed using an 11-point numerical rating scale. The Vienna Test System-Traffic Plus was used to assess cognitive and psychomotor function. The key surrogate parameter for driving ability was a global judgment based on 6 battery tests.ResultsThirty-eight patients enrolled and completed the trial, and 35 patients completed all 6 tests. Pain scores remained unchanged from enrollment to final visit [mean (standard deviation) change, –0.2 (1.0)]. Approximately two-thirds [65.7% (23/35)] of patients were classified as fit to drive based on the global judgment of driving-specific ability [34.3% (12/35) not fit to drive]. Total daily tapentadol PR dose (>200 vs. ≤200 mg/day) did not affect global judgment of driving ability (P = 0.4885). Two adverse events (considered unrelated to study drug) were reported.ConclusionResults suggest that most patients receiving a stable dose of tapentadol PR for severe, chronic pain would be able to drive, consistent with earlier studies evaluating stable treatment with strong opioids. Study design limitations and needs for individual patient assessment must be considered in clinical practice.Electronic supplementary materialThe online version of this article (doi:10.1007/s40122-014-0025-3) contains supplementary material, which is available to authorized users.

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The impact of long-term maintenance treatment with buprenorphine on complex psychomotor and cognitive function

Cited by 33 publications

References 33 publications

Assessing Cognitive and Psychomotor Performance in Patients with Fibromyalgia Syndrome

Assessing Cognitive and Psychomotor Performance in Patients with Fibromyalgia Syndrome

Effects of buprenorphine on behavioral tests for antidepressant and anxiolytic drugs in mice

Driving Ability in Patients with Severe Chronic Low Back or Osteoarthritis Knee Pain on Stable Treatment with Tapentadol Prolonged Release: A Multicenter, Open-label, Phase 3b Trial

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