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1.
Artigo em Inglês | MEDLINE | ID: mdl-32030595

RESUMO

The paper describes the Antipsychotic Medication Management Fidelity Scale and its psychometric properties, including interrater reliability, frequency distribution, sensitivity to change and feasibility. Fidelity assessors conducted fidelity reviews four times over 18 months at eight sites receiving implementation support for evidence-based antipsychotic medication management. Data analyses shows good to fair interrater reliability, adequate sensitivity to change over time and good feasibility. At 18 months, item ratings varied from poor to full fidelity on most items. Use of the scale can assess fidelity to evidence-based guidelines for antipsychotic medication management and guide efforts to improve practice. Further research should improve and better calibrate some items, and improve the procedures for access to information.Trial registration: ClinicalTrials.gov Identifier: NCT03271242.

2.
Medicine (Baltimore) ; 99(1): e18635, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31895824

RESUMO

This cross sectional study examined patients' perceptions of professional support regarding use of psychotropic medication in a specialist mental health care setting. The aims were to evaluate reliability and validity of the MedSupport inventory, and investigate possible associations between MedSupport scores and patient characteristics.A cross-sectional study was performed. The patients completed the MedSupport, a newly developed self-reported 6 item questionnaire on a Likert scale ranged 1 to 5 (1 = strongly disagree to 5 = strongly agree), and the Beliefs about Medicines Questionnaire. Diagnosis and treatment information were obtained at the clinical visits and from patient records.Among the 992 patients recruited, 567 patients (57%) used psychotropic medications, and 514 (91%) of these completed the MedSupport and were included in the study. The MedSupport showed an adequate internal consistency (Cronbach alpha.87; 95% CI.86-89) and a convergent validity toward the available variables. The MedSupport mean score was 3.8 (standard deviation.9, median 3.8). Increasing age and the experience of stronger needs for psychotropic medication were associated with perception of more support to cope with medication, whereas higher concern toward use of psychotropic medication was associated with perception of less support. Patients diagnosed with behavioral and emotional disorders, onset in childhood and adolescence perceived more support than patients with Mood disorders.The MedSupport inventory was suitable for assessing the patients' perceived support from health care service regarding their medication. Awareness of differences in patients' perceptions might enable the service to provide special measures for patients who perceive insufficient medication support.


Assuntos
Transtornos Mentais/tratamento farmacológico , Serviços de Saúde Mental , Psicotrópicos/uso terapêutico , Adulto , Estudos Transversais , Feminino , Humanos , Masculino , Transtornos Mentais/psicologia , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Inquéritos e Questionários , Adulto Jovem
3.
J Pain Res ; 12: 2875-2889, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31686904

RESUMO

Objective: Neuropathic pain and fibromyalgia are two common and poorly understood chronic pain conditions that lack satisfactory treatments, cause substantial suffering and societal costs. Today, there are no biological markers on which to base chronic pain diagnoses, treatment choices or to understand the pathophysiology of pain for the individual patient. This study aimed to investigate cerebrospinal fluid (CSF) protein profiles potentially associated with fibromyalgia and neuropathic pain. Methods: CSF samples were collected from 25 patients with neuropathic pain (two independent sets, n=14 patients for discovery, and n=11 for verification), 40 patients with fibromyalgia and 134 controls without neurological disease from two different populations. CSF protein profiling of 55 proteins was performed using antibody suspension bead array technology. Results: We found increased levels of apolipoprotein C1 (APOC1) in CSF of neuropathic pain patients compared to controls and there was a trend for increased levels also in fibromyalgia patients. In addition, levels of ectonucleotide pyrophosphatase family member 2 (ENPP2, also referred to as autotaxin) were increased in the CSF of fibromyalgia patients compared to all other groups including patients with neuropathic pain. Conclusion: The increased levels of APOC1 and ENPP2 found in neuropathic pain and fibromyalgia patients may shed light on the underlying mechanisms of these conditions. Further investigation is required to elucidate their role in maintaining pain and other main symptoms of these disorders.

4.
J Eval Clin Pract ; 25(6): 1041-1049, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31508872

RESUMO

RATIONALE AND AIMS: There is a growing expectation of implementing shared decision making (SDM) in today's health care service, including mental health care. Traditional understanding of SDM may be too narrow to capture the complexity of treatments of mental health problems. Although the patients' contribution to SDM is well described, the contribution from the health care practitioners is less explored. Therefore, our aim was to explore the attitudes of practitioners in mental health care and the associations between practitioners' attitudes and SDM. METHOD: We performed a cross-sectional study where practitioners reported their sharing and caring attitudes on the Patient-Practitioner Orientation Scale (PPOS) and age, gender, profession, and clinical working site. The patients reported SDM using the CollaboRate tool. We used a mixed effect model linking the data from each practitioner to one or more patients. We presented the findings and used them as background for a more philosophic reflection. RESULTS: We included 312 practitioners with mean age 46.1 years. Of the practitioners, 60 held a medical doctors degree, 97 were psychologists, and 127 held a college degree in nursing, social science, or pedagogy. Female practitioners reported higher sharing (4.79 vs 4.67 [range 1-6], P = .04) and caring scores (4.77 vs 4.65 [range 1-6], P = .02) than males. The regression model contained 206 practitioners and 772 patients. We found a higher probability for the patient to report high SDM score if the practitioner reported higher sharing scores, and lower probability if the practitioner worked in ambulatory care. CONCLUSIONS: SDM in mental health care is complex and demands multifaceted preparations from practitioners as well as patients. The practitioners' attitudes are not sufficiently explored using one instrument. The positive association between practitioners' patient-centred attitudes and SDM found in this study implies a relevance of the practitioners' attitudes for accomplishment of SDM processes in mental health care.

5.
Eur Addict Res ; 25(6): 303-309, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31340204

RESUMO

BACKGROUND AND OBJECTIVE: Opioid maintenance treatment (OMT) is highly available in Norway, but only 50% of opioid-dependent individuals are enrolled in such programs. This study was aimed at examining if availability of extended-release naltrexone (XR-NTX) could attract individuals who for different reasons were not enrolled in an OMT program. METHODS: In a Norwegian clinical study, n = 117 opioid-dependent adults volunteered to receive XR-NTX in a 9-month period, as an extension of a previous randomized clinical trial. RESULTS: Before study inclusion, 40.2% (n = 47) of the study participants were not enrolled in OMT while the remainder were recruited from OMT. Participants not enrolled in OMT displayed more ongoing severe addiction-related problems such as heroin use (p = 0.002), but displayed a higher retention in treatment in the 9-month extension study (p = 0.048 for log-rank test) than participants enrolled in OMT. CONCLUSION: Availability of XR-NTX attracted opioid-dependent individuals not previously enrolled in OMT. While OMT may be perceived as a burden with regard to daily intake and control measures, one-monthly injections with XR-NTX may be perceived favourable, offering more freedom to the patients, not having addictive properties, and potentially reducing heroin craving. We suggest that an introduction of XR-NTX in Europe may increase the number of opioid-dependent individuals in treatment.

6.
Am J Addict ; 28(2): 77-85, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30701613

RESUMO

BACKGROUND AND OBJECTIVES: It 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. METHODS: This 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. RESULTS: Throughout 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 CONCLUSIONS: Among 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 SIGNIFICANCE: In opioid-dependent individuals, mild-to-moderate chronic pain was not influenced by opioid agonist or antagonist treatment. TRIAL REGISTRATION: Clinicaltrials.gov #NCT01717963, first registered: Oct 28, 2012. Protocol version # 3C, June 12th 2012. (Am J Addict 2018;XX:1-9).


Assuntos
Combinação Buprenorfina e Naloxona , Dor Crônica/diagnóstico , Naltrexona , Adulto , Combinação Buprenorfina e Naloxona/administração & dosagem , Combinação Buprenorfina e Naloxona/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Naltrexona/administração & dosagem , Naltrexona/efeitos adversos , Antagonistas de Entorpecentes/uso terapêutico , Noruega , Tratamento de Substituição de Opiáceos/métodos , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Medição da Dor
7.
J Proteomics ; 190: 35-43, 2019 01 06.
Artigo em Inglês | MEDLINE | ID: mdl-29656018

RESUMO

Fibromyalgia (FM) is a syndrome characterized by widespread muscular pain, fatigue and functional symptoms, which is known to be difficult to diagnose as the various symptoms overlap with many other conditions. Currently, there are no biomarkers for FM, and the diagnosis is made subjectively by the clinicians. We have performed shotgun proteomics on cerebrospinal fluid (CSF) from FM patients and non-pain controls to find potential biomarker candidates for this syndrome. Based on our multivariate and univariate analyses, we found that the relative differences in the CSF proteome between FM patients and controls were moderate. Four proteins, important to discriminate FM patients from non-pain controls, were found: Apolipoprotein C-III, Galectin-3-binding protein, Malate dehydrogenase cytoplasmic and the neuropeptide precursor protein ProSAAS. These proteins are involved in lipoprotein lipase (LPL) activity, inflammatory signaling, energy metabolism and neuropeptide signaling. SIGNIFICANCE: Fibromyalgia is present in as much as 2% of the population, causing pain, stiffness, and tenderness of the muscles. Upon accurate diagnostic, nonpharmacological and pharmacological therapies can be used to alleviate pain and manage other symptoms. However, lack of objective, universal applicable diagnostic criteria as well as vague and diffused symptoms, have made diagnosis difficult. In this context, our findings can shed light on potential value of CSF proteome for objectively diagnosing FM.

8.
JAMA Psychiatry ; 76(2): 127-134, 2019 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-30566177

RESUMO

Importance: Extended-release naltrexone (XR-NTX) is a promising alternative treatment of opioid addiction but has never been compared with opioid agonist treatment for effects on symptoms of anxiety, depression, and insomnia. Objective: To investigate whether XR-NTX unmasks or reinforces current comorbid symptoms of anxiety, depression, or insomnia compared with opioid agonist treatment. Design, Setting, and Participants: In this prospective randomized clinical trial, 159 men and women aged 18 to 60 years with opioid dependence were randomized to 12 weeks of treatment with either XR-NTX or combined buprenorphine-naloxone (BP-NLX) followed by a 9-month, open-label treatment study with participant choice of 1 of these 2 drugs. The study was conducted at outpatient addiction clinics in 5 urban hospitals in Norway, with the clinical trial performed from November 1, 2012, to October 23, 2015, and the follow-up study completed on July 23, 2016. All analyses were conducted using an intention-to-treat sample. Interventions: Extended-release naltrexone hydrochloride, 380 mg, administered as an injection every 4 weeks or flexible doses (4-24 mg; target dosage 16 mg/d) of daily oral combined BP-NLX. Main Outcomes and Measures: Every 4 weeks, symptoms of anxiety and depression were assessed using the 25-item Hopkins Symptom Checklist, and symptoms of insomnia were assessed using the Insomnia Severity Index. Results: In total, 159 participants were randomized to treatment with either XR-NTX (n = 80) or BP-NLX (n = 79), and 105 participants (66.0%) completed the trial. The treatment groups showed similar distributions of age (mean [SD], 36.4 [8.8] vs 35.7 [8.5] years), sex (61 [76.3%] women and 54 [68.4%] men), and duration of heroin use (mean [SD], 6.9 [5.8] vs 6.7 [5.2] years). For the clinical trial period, no overall differences were detected between treatment groups for anxiety (effect size [95% CI], -0.14 [-0.47 to 0.19]) or depression (effect size [95% CI], -0.12 [-0.45 to 0.21]) scores, but the insomnia score was significantly lower in the XR-NTX group (effect size [95% CI], -0.32 [-0.61 to -0.02]; P = .008). In the follow-up period, no overall differences could be detected in the effect size [95% CI] of scores for anxiety (0.04 [-0.34 to 0.42]), depression (-0.04 [-0.42 to 0.33]), or insomnia (0.04 [-0.33 to 0.42]) between participants continuing with and participants switching to XR-NTX. No significant sex differences between the 2 treatment groups were detected. Conclusions and Relevance: Comorbid symptoms of anxiety, depression, or insomnia in abstinence-motivated persons with opioid dependence should not prevent switching from treatment with an opioid agonist to treatment with XR-NTX. Trial Registration: ClinicalTrials.gov Identifier: NCT01717963.

9.
Addiction ; 113(10): 1840-1849, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-29806872

RESUMO

BACKGROUND AND AIM: This is a follow-up study of a previously published randomized clinical trial conducted in Norway that compared extended-release naltrexone (XR-NTX) to buprenorphine-naloxone (BP-NLX) over 3 months. At the conclusion of the trial, participants were offered their choice of study medication for an additional 9 months. While BP-NLX was available at no cost through opioid maintenance treatment programmes, XR-NTX was available only through study participation, accounting for why almost all participants chose XR-NTX in the follow-up. The aim of this follow-up study was to compare differences in outcome between adults with opioid dependence continuing XR-NTX and those inducted on XR-NTX for a 9-month period, on measures of effectiveness, safety and feasibility. DESIGN: In this prospective cohort study, participants were either continuing XR-NTX, changed from BP-NLX to XR-NTX or re-included into the study and inducted on XR-NTX treatment. SETTING: Five urban, out-patient addiction clinics in Norway. PARTICIPANTS: Opioid-dependent adults continuing (n = 54) or inducted on (n = 63) XR-NTX. INTERVENTION: XR-NTX administrated as intramuscular injections (380 mg) every fourth week. MEASUREMENTS: Data on retention, use of heroin and other illicit substances, opioid craving, treatment satisfaction, addiction-related problems and adverse events were reported every fourth week. FINDINGS: Nine-month follow-up completion rates were 51.9% among participants continuing XR-NTX in the follow-up and 47.6% among those inducted on XR-NTX. Opioid abstinence rates were, respectively, 53.7 and 44.4%. No significant group differences were found in use of heroin and other opioids. CONCLUSIONS: Opioid-dependent individuals who elect to switch from buprenorphine-naltrexone treatment after 3 months to extended-release naltrexone treatment for 9 months appear to experience similar treatment completion and abstinence rates and similar adverse event profiles to individuals who had been on extended-release naltrexone from the start of treatment.


Assuntos
Naltrexona/administração & dosagem , Antagonistas de Entorpecentes/administração & dosagem , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Adulto , Combinação Buprenorfina e Naloxona/uso terapêutico , Estudos de Coortes , Preparações de Ação Retardada , Estudos de Viabilidade , Feminino , Humanos , Injeções Intramusculares , Masculino , Noruega , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
10.
JAMA Psychiatry ; 74(12): 1197-1205, 2017 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-29049469

RESUMO

Importance: To date, extended-release naltrexone hydrochloride has not previously been compared directly with opioid medication treatment (OMT), currently the most commonly prescribed treatment for opioid dependence. Objective: To determine whether treatment with extended-release naltrexone will be as effective as daily buprenorphine hydrochloride with naloxone hydrochloride in maintaining abstinence from heroin and other illicit substances in newly detoxified individuals. Design, Setting and Participants: A 12-week, multicenter, outpatient, open-label randomized clinical trial was conducted at 5 urban addiction clinics in Norway between November 1, 2012, and December 23, 2015; the last follow-up was performed on October 23, 2015. A total of 232 adult opioid-dependent (per DSM-IV criteria) individuals were recruited from outpatient addiction clinics and detoxification units and assessed for eligibility. Intention-to-treat analyses of efficacy end points were performed with all randomized participants. Interventions: Randomization to either daily oral flexible dose buprenorphine-naloxone, 4 to 24 mg/d, or extended-release naltrexone hydrochloride, 380 mg, administered intramuscularly every fourth week for 12 weeks. Main Outcomes and Measures: Primary end points (protocol) were the randomized clinical trial completion rate, the proportion of opioid-negative urine drug tests, and number of days of use of heroin and other illicit opioids. Secondary end points included number of days of use of other illicit substances. Safety was assessed by adverse event reporting. Results: Of 159 participants, mean (SD) age was 36 (8.6) years and 44 (27.7%) were women. Eighty individuals were randomized to extended-release naltrexone and 79 to buprenorphine-naloxone; 105 (66.0%) completed the trial. Retention in the extended-release naltrexone group was noninferior to the buprenorphine-naloxone group (difference, -0.1; with 95% CI, -0.2 to 0.1; P = .04), with mean (SD) time of 69.3 (25.9) and 63.7 (29.9) days, correspondingly (P = .33, log-rank test). Treatment with extended-release naltrexone showed noninferiority to buprenorphine-naloxone on group proportion of total number of opioid-negative urine drug tests (mean [SD], 0.9 [0.3] and 0.8 [0.4], respectively, difference, 0.1 with 95% CI, -0.04 to 0.2; P < .001) and use of heroin (mean difference, -3.2 with 95% CI, -4.9 to -1.5; P < .001) and other illicit opioids (mean difference, -2.7 with 95% CI, -4.6 to -0.9; P < .001). Superiority analysis showed significantly lower use of heroin and other illicit opioids in the extended-release naltrexone group. No significant differences were found between the treatment groups regarding most other illicit substance use. Conclusions and Relevance: Extended-release naltrexone was as effective as buprenorphine-naloxone in maintaining short-term abstinence from heroin and other illicit substances and should be considered as a treatment option for opioid-dependent individuals. Trial Registration: clinicaltrials.gov Identifier: NCT01717963.


Assuntos
Combinação Buprenorfina e Naloxona , Naloxona , Tratamento de Substituição de Opiáceos/métodos , Transtornos Relacionados ao Uso de Opioides , Administração Oral , Adulto , Combinação Buprenorfina e Naloxona/administração & dosagem , Combinação Buprenorfina e Naloxona/farmacocinética , Preparações de Ação Retardada , Manual Diagnóstico e Estatístico de Transtornos Mentais , Monitoramento de Medicamentos/métodos , Feminino , Humanos , Injeções Intramusculares , Masculino , Naloxona/administração & dosagem , Naloxona/farmacocinética , Antagonistas de Entorpecentes/administração & dosagem , Antagonistas de Entorpecentes/farmacocinética , Transtornos Relacionados ao Uso de Opioides/diagnóstico , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Escalas de Graduação Psiquiátrica , Detecção do Abuso de Substâncias/métodos , Resultado do Tratamento
11.
Acta Derm Venereol ; 97(8): 897-905, 2017 Aug 31.
Artigo em Inglês | MEDLINE | ID: mdl-28512664

RESUMO

There is increasing evidence of clinically relevant anti-inflammatory effects of monoaminergic antidepressants. PubMed and Ovid databases were searched systematically for the use and efficacy of antidepressants in association with 5 common inflammatory skin disorders: chronic urticaria, psoriasis, atopic dermatitis, other eczema, and alopecia areata. From January 1984 to June 2016, publications included a total of 1,252 dermatological patients in 28 trials or case reports. These unambiguously reported a reduced burden of dermatological symptoms in relation to treatment with antidepressants. Several randomized controlled trials of first-generation antidepressants have been published, while studies of modern antidepressants are usually open-label, yet more informative, regarding patients' characteristics and study procedures. These overall positive findings may indicate a rationale, beyond treating comorbid psychiatric disorders, for the use of antidepressants in dermatology. Further research into modern tolerable antidepressants, including selective serotonin re-uptake inhibitors, mirtazapine and bupropion, is required.


Assuntos
Anti-Inflamatórios/uso terapêutico , Antidepressivos de Segunda Geração/uso terapêutico , Fármacos Dermatológicos/uso terapêutico , Inibidores da Captação de Dopamina/uso terapêutico , Inibidores de Captação de Serotonina/uso terapêutico , Dermatopatias/tratamento farmacológico , Anti-Inflamatórios/efeitos adversos , Antidepressivos de Segunda Geração/efeitos adversos , Fármacos Dermatológicos/efeitos adversos , Inibidores da Captação de Dopamina/efeitos adversos , Humanos , Inibidores de Captação de Serotonina/efeitos adversos , Dermatopatias/diagnóstico , Dermatopatias/epidemiologia , Resultado do Tratamento
12.
J Pain Res ; 10: 515-525, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28424559

RESUMO

In addition to central hyperexcitability and impaired top-down modulation, chronic inflammation probably plays a role in the pathophysiology of fibromyalgia (FM). Indeed, on the basis of both animal experiments and human studies involving the analysis of cytokines and other inflammation-related proteins in different body fluids, neuroinflammatory mechanisms are considered to be central to the pathophysiology of many chronic pain conditions. However, concerning FM, previous human plasma/serum and/or cerebrospinal fluid (CSF) cytokine studies have looked only at a few predetermined cytokine candidates. Instead of analyzing only a few substances at a time, we used a new multiplex protein panel enabling simultaneous analysis of 92 inflammation-related proteins. Hence, we investigated the CSF and plasma inflammatory profiles of 40 FM patients compared with CSF from healthy controls (n=10) and plasma from blood donor controls (n=46). Using multivariate data analysis by projection, we found evidence of both neuroinflammation (as assessed in CSF) and chronic systemic inflammation (as assessed in plasma). Two groups of proteins (one for CSF and one for plasma) highly discriminating between patients and controls are presented. Notably, we found high levels of CSF chemokine CX3CL1 (also known as fractalkine). In addition, previous findings concerning IL-8 in FM were replicated, in both CSF and plasma. This is the first time that such an extensive inflammatory profile has been described for FM patients. Hence, FM seems to be characterized by objective biochemical alterations, and the lingering characterization of its mechanisms as essentially idiopathic or even psychogenic should be seen as definitively outdated.

13.
Eur Addict Res ; 22(6): 301-305, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27434137

RESUMO

BACKGROUND/AIMS: Treatment for addiction to illicit opioids has, thus far, been limited to 2 main approaches: maintaining physical dependence by administering opioids medically and medication-free abstinence with psychosocial support. Assisted abstinence by taking daily tablets with the opioid antagonist naltrexone is rarely practiced, but it is unclear whether this is due to the limited efficacy of this method or because of user opposition to antagonist medication. Therefore, we wanted to investigate opioid users' interest in antagonist treatment with naltrexone, administered as extended release injection, which supports abstinence by blocking illicit opioids for 4-5 weeks per administration. METHOD: A one-page questionnaire was distributed among opiate users at a broad range of outreach facilities and a total of 731 answered surveys were analysed. RESULTS: More than half of the opioid users in our study were 'very' or 'quite' interested in receiving a 4-weekly opioid-blocking medication for a year (n = 421), while less than a quarter (n = 164) were 'not interested' at all. CONCLUSION: We discovered a high user interest for naltrexone treatment, suggesting that the interest for such treatment was not a barrier to the implementation of extended release naltrexone treatment.


Assuntos
Naltrexona/administração & dosagem , Antagonistas de Entorpecentes/administração & dosagem , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Transtornos Relacionados ao Uso de Opioides/psicologia , Inquéritos e Questionários , Adulto , Idoso , Preparações de Ação Retardada/administração & dosagem , Feminino , Humanos , Injeções Subcutâneas , Masculino , Pessoa de Meia-Idade , Adulto Jovem
14.
BMC Pharmacol Toxicol ; 17(1): 18, 2016 04 28.
Artigo em Inglês | MEDLINE | ID: mdl-27121539

RESUMO

BACKGROUND: Current guidelines for opioid dependence recommend daily maintenance of physical dependence with methadone or buprenorphine, and discourage abstinence due to the high risk of relapse and overdose. Extended-release formulations of the opioid antagonist naltrexone (XR-NTX) block heroin and other opioid agonists competitively for around 4 weeks per administration. XR-NTX thus enables opioid users to experience abstinence from opioid agonists with greatly reduced risk of overdose compared to medication-free abstinence. While XR-NTX has shown promise compared to placebo and daily naltrexone tablets, there is limited information on long-term safety and its performance compared to daily maintenance treatment. METHODS/DESIGN: In this five-hospital RCT with long-term follow-up, we aim to recruit n = 180 patients in treatment for opioid dependence and allocate them in an open, randomized manner (1:1) to receive either 4-week XR-NTX or daily buprenorphine-naloxone (BP-NLX) for the duration of 12 weeks. Allocation is open-label due to the risk of overdose during attempts to self-unmask allocation using heroin. Urine drug tests are scheduled every week with follow-up visits & assessment every 4 weeks. Primary outcomes are abstinence from illicit opioids in urine drug tests and self-report, as well as retention in treatment. Secondary outcomes include other substance use, injecting behavior, drug craving, mental health, quality of life, treatment satisfaction, abstinence motivation, opioid agonist effect rating, insomnia, and pain. Observation is continued for another 36 weeks in order to assess longer-term safety, adherence and effectiveness. The study is an investigator-initiated trial, funded by public grants and approved by an Independent Ethical Committee (the Regional Ethical Committee for Research South-East B # 2011/1320) and the Norwegian Medicines Agency. DISCUSSION: Despite minor implementation problems, the protocol appears sufficiently robust to generate results of high interest to patients, clinicians and policy makers. TRIAL REGISTRATION: Clinicaltrials.gov # NCT01717963 , first registered: Oct 28, 2012. Protocol version # 3C, June 12th 2012.


Assuntos
Combinação Buprenorfina e Naloxona/administração & dosagem , Naltrexona/administração & dosagem , Antagonistas de Entorpecentes/administração & dosagem , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Adulto , Preparações de Ação Retardada/administração & dosagem , Feminino , Seguimentos , Humanos , Injeções Intramusculares , Masculino , Noruega/epidemiologia , Transtornos Relacionados ao Uso de Opioides/diagnóstico
15.
J ECT ; 32(3): 151-8, 2016 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-26909824

RESUMO

OBJECTIVES: Bifrontal (BF) electrode placement has been explored to refine the electroconvulsive therapy (ECT) technique. No previous study has compared the cognitive effects of BF versus right unilateral (RUL) ECT by only including the subgroup that is most likely to receive it: elderly patients with major depression. METHODS: Nondemented patients (n = 65) with major depression, aged 60 to 85 years, were randomly allocated to BF ECT and RUL formula-based ECT. Cognitive function was assessed at baseline (T1), within 1 week after a course of ECT (T2), and 3 months after T2 (T3). Six neuropsychological test measures of memory, 5 of executive function, and 3 of information-processing speed were administered. RESULTS: According to linear mixed models, there were no significant differences between the BF and RUL groups at any time. The retrograde memory score for public facts declined more for the RUL group (P < 0.001) than the BF group (P = 0.005) from baseline to the first retest and remained stable for both groups from T2 to T3. A rapid improvement in selective attention was observed in the RUL group from T1 to T2, but the scores remained stable from T2 to T3 (P < 0.001). This measure remained stable in the BF group from T1 to T3. CONCLUSIONS: Our findings indicate that there were negligible differences in the cognitive effects of formula-based BF or RUL ECT. The overall cognitive effects of ECT were equally favorable for each of the groups.


Assuntos
Transtorno Depressivo Maior/psicologia , Transtorno Depressivo Maior/terapia , Eletroconvulsoterapia/métodos , Idoso , Idoso de 80 Anos ou mais , Atenção , Eletrodos , Função Executiva , Feminino , Humanos , Masculino , Memória , Pessoa de Meia-Idade , Testes Neuropsicológicos , Escalas de Graduação Psiquiátrica , Método Simples-Cego , Resultado do Tratamento
16.
J Affect Disord ; 190: 178-186, 2016 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-26519638

RESUMO

BACKGROUND: No study has previously investigated whether the speed of recovery from disorientation in the post-ictal period may predict the short-term treatment outcome of electroconvulsive therapy (ECT). METHODS: This longitudinal cohort study included 57 elderly patients with unipolar or bipolar major depression, aged 60-85 years, treated with formula-based ECT. Treatment outcome was assessed weekly during the ECT course using the 17-item Hamilton Rating Scale for Depression (HRSD17). The post-ictal reorientation time (PRT) was assessed at the first and third treatments. RESULTS: Longer PRTs at the first and third treatments predicted a more rapid decline and a lower end-point in continuous HRSD17 scores (p=0.002 and 0.019, respectively). None of the patients who recovered from disorientation in less than 5 min met the remission criterion, defined as an HRSD17 score of 7 or less. A greater increment in stimulus dosage from the first to the third ECT session rendered a smaller relative decline in PRT (p<0.001). LIMITATIONS: The limited number of subjects may reduce the generalizability of the findings. CONCLUSIONS: The speed of recovery from disorientation at the first and third sessions seems to be a predictor of the treatment outcome of formula-based ECT, at least in elderly patients with major depression. It remains to be clarified how the PRT may be utilized to guide stimulus dosing.


Assuntos
Transtorno Bipolar/terapia , Confusão/terapia , Transtorno Depressivo Maior/terapia , Eletroconvulsoterapia/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Transtorno Bipolar/epidemiologia , Estudos de Coortes , Comorbidade , Confusão/epidemiologia , Transtorno Depressivo Maior/epidemiologia , Feminino , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Indução de Remissão , Resultado do Tratamento
17.
J Affect Disord ; 185: 67-75, 2015 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-26143406

RESUMO

BACKGROUND: No prior study has investigated whether impairment of specific cognitive functions at baseline may predict the short-term treatment outcome of electroconvulsive therapy (ECT) in elderly non-demented patients with major depression (MD). METHODS: This longitudinal cohort study included 65 elderly patients with unipolar or bipolar MD, aged 60-85 years, treated with formula-based ECT. Treatment outcome was assessed using the 17-item Hamilton Rating Scale for Depression (HRSD17). Cognitive function at baseline was assessed using nine neuropsychological tests or subtests measuring information processing speed, verbal learning and memory, and aspects of executive function. RESULTS: A poorer performance on the word reading task of the Color Word Interference Test rendered higher odds of achieving remission during the ECT course (p=0.021). Remission was defined as an HRSD17 score of 7 or less. There were no other significant associations between the treatment outcome of ECT and cognitive performance parameters assessed at baseline. LIMITATIONS: The limited number of subjects may have reduced the generalizability of the findings. Multiple statistical tests increase the risk for making a type I error. CONCLUSIONS: How well patients perform on neuropsychological tests at baseline is most likely not a predictor of, or otherwise not significantly associated with the treatment outcome of formula-based ECT in elderly patients with MD.


Assuntos
Transtorno Bipolar/psicologia , Transtorno Bipolar/terapia , Cognição/fisiologia , Transtorno Depressivo/psicologia , Transtorno Depressivo/terapia , Eletroconvulsoterapia , Idoso , Idoso de 80 Anos ou mais , Transtornos Cognitivos/psicologia , Estudos de Coortes , Função Executiva , Feminino , Avaliação Geriátrica/estatística & dados numéricos , Humanos , Estudos Longitudinais , Masculino , Memória , Pessoa de Meia-Idade , Testes Neuropsicológicos , Escalas de Graduação Psiquiátrica , Resultado do Tratamento , Aprendizagem Verbal
18.
Clin Neuropsychol ; 29(4): 487-508, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26029851

RESUMO

OBJECTIVE: Electroconvulsive therapy (ECT) is an effective biological treatment option for severely depressed elderly patients; however, it can cause cognitive side effects, including anterograde and retrograde amnesia. Elderly patients with "cognitive impairment no dementia" (CIND) are reported as being more vulnerable to the cognitive side effects of ECT compared with patients with "no cognitive impairment" (NCI). The few studies that have reached this conclusion can be criticized for using insensitive outcome measures. METHOD: The present study investigated cognitive side effects using standard neuropsychological tests before and after twice-weekly ECT. Patients were assessed at baseline (T1) and within one week after a course of ECT (consisting of a mean of 10 treatments) (T2), and were followed up for three months after T2 (T3). The sample included 54 patients with NCI (n = 36) or CIND (n = 18). For a control group, we recruited 17 healthy elderly persons. Tests of anterograde memory, information-processing speed, executive function, and retrograde memory were administered. We computed reliable change indices using simple regression methods. RESULTS: Short-term side effects were detected at T2 in a large minority of patients, with no significant differences between NCI and CIND patients. Considerable improvement in global cognitive function from T1 to T3 was observed in 44% of the CIND patients. At the group level, information-processing speed improved significantly in CIND vs. NCI patients. CONCLUSIONS: CIND patients were not more vulnerable to amnesia than were NCI patients. Long-term cognitive side effects of ECT were not detected.


Assuntos
Amnésia/etiologia , Transtornos Cognitivos/etiologia , Cognição , Transtorno Depressivo Maior/psicologia , Transtorno Depressivo Maior/terapia , Eletroconvulsoterapia/efeitos adversos , Idoso , Amnésia Anterógrada/etiologia , Amnésia Retrógrada/etiologia , Função Executiva , Feminino , Humanos , Masculino , Memória , Pessoa de Meia-Idade , Testes Neuropsicológicos , Resultado do Tratamento
19.
Eur Addict Res ; 21(5): 253-61, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-25967268

RESUMO

BACKGROUND: The tapering of methadone or buprenorphine during pregnancy is an understudied and controversial issue. The aim of this study was to determine to what extent women tapered their opioid medication dose during pregnancy and what the neonatal outcomes were for those who tapered compared to the women who did not. METHODS: The study was a mixed prospective/retrospective national cohort study of 123 Norwegian women in opioid maintenance treatment (OMT) during pregnancy and their neonates. A standardized questionnaire was administered to the women and medical information that could be used for verification was collected from hospitals and municipalities. RESULTS: Two of the women came off the OMT-medication during pregnancy and another 15% tapered their OMT-medication dose more than 50%. The birth weights of methadone-exposed neonates of the women who tapered more than 50% were significantly higher than for the methadone-exposed neonates of the women tapering between 11 and 50%. No other significant differences were found. CONCLUSION: Pregnant women in OMT who taper their OMT-medication dose should be monitored closely. We need studies that document the maternal well-being and fetal safety of maternal tapering of the OMT-medication during pregnancy.


Assuntos
Peso ao Nascer/efeitos dos fármacos , Buprenorfina/administração & dosagem , Buprenorfina/efeitos adversos , Metadona/administração & dosagem , Metadona/efeitos adversos , Tratamento de Substituição de Opiáceos/efeitos adversos , Resultado da Gravidez , Adulto , Esquema de Medicação , Feminino , Humanos , Recém-Nascido , Masculino , Antagonistas de Entorpecentes/administração & dosagem , Antagonistas de Entorpecentes/efeitos adversos , Entorpecentes/administração & dosagem , Entorpecentes/efeitos adversos , Noruega/epidemiologia , Gravidez , Estudos Prospectivos , Estudos Retrospectivos
20.
J Clin Psychiatry ; 76(1): e111-6, 2015 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25650676

RESUMO

OBJECTIVE: Antipsychotic agents have serious metabolic adverse effects, among them dyslipidemia, which may necessitate secondary prophylaxis with cholesterol-lowering drugs. Second-generation antipsychotics (SGAs), particularly clozapine and olanzapine, are known to confer a higher risk of metabolic adverse effects than first-generation antipsychotics (FGAs). However, little is known regarding the real-life number of antipsychotic-treated patients receiving statins. METHOD: By extracting data from the Norwegian prescription database, all patients 18-69 years old that started treatment with an antipsychotic during 2004-2012 formed the basis for analysis (n = 301,713). The primary outcome measure was the proportion of FGA and SGA users prescribed with cholesterol-lowering agent during the same period. We used Cox proportional hazards regression to evaluate the risk of redeeming a cholesterol-lowering drug for formerly antipsychotic drug-naive patients (n = 147,218). RESULTS: Statin prescription rates in patients receiving antipsychotic agents were lower (5.3%) than comparable rates in studies covering the general population (34%) and lower than would be expected based on the recognized negative impact of antipsychotics on serum lipids. Statin prescription rates were affected by patient age, antipsychotic dose, and the number of antipsychotic agents prescribed, but rates were only 5% elevated in patients receiving SGAs compared to patients receiving FGAs (P = .048). CONCLUSIONS: Our results may support the notion that patients treated with antipsychotic agents receive suboptimal care with regard to metabolic adverse effects.


Assuntos
Antipsicóticos/uso terapêutico , Prescrições de Medicamentos/estatística & dados numéricos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Adolescente , Adulto , Idoso , Antipsicóticos/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Noruega/epidemiologia , Adulto Jovem
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