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

2021 ◽  
pp. 1-12
Author(s):  
Zhanna Gaulen ◽  
Ida Halvorsen Brenna ◽  
Lars Thore Fadnes ◽  
Jūratė Šaltytė Benth ◽  
Kristin K. Solli ◽  
...  
Keyword(s):  
Treatment Adherence ◽  
Extended Release ◽  
Adherence Rate ◽  
Adherence To Treatment ◽  
Opioid Use ◽  
Open Label ◽  
Short Term Treatment ◽  
Baseline Preference ◽  
Risk Of Relapse

<b><i>Background:</i></b> Extended-release naltrexone (XR-NTX) is effective for illicit opioid abstinence as an opioid maintenance treatment. To improve treatment outcomes, patient’s preference for the modality of treatment is an important factor. <b><i>Objectives:</i></b> We aimed to test the relationship between baseline preference for XR-NTX and adherence to treatment, use of illicit opioids, and risk of relapse. <b><i>Methods:</i></b> In an open-label, Norwegian clinical trial participants with opioid use disorder were randomized to either monthly injections with XR-NTX or daily sublingual buprenorphine-naloxone (BP-NLX) for 12 weeks. Subsequently, participants could continue with their preferred medication in a 36-week follow-up and in a prolonged period of 104 weeks. <b><i>Results:</i></b> Of 153 participants who completed detoxification, 72% were men, with a mean age of 36 years. Preference levels were similar across the randomized groups, with no significant associations between preference and adherence to treatment, opioid use, or relapse. The BP-NLX group had a significantly higher risk of first relapse to opioids than the XR-NTX group for all levels of preference (<i>p</i> &#x3c; 0.001) and a significantly higher number of days of illicit opioid use. In the follow-up period, the adherence rate was twice as high among participants with the highest preference compared to participants with the lowest preference, both among those who switched to XR-NTX and those who continued (hazard ratio 2.2; 1.2–4.0, <i>p</i> = 0.013). Opioid use was significantly higher among participants who switched to XR-NTX with the lowest preference than the medium (<i>p</i> = 0.003) or the highest (<i>p</i> = 0.001) preference. The risk of relapse to opioids, however, was significantly higher among XR-NTX continuing participants with the lowest (<i>p</i> = 0.002) or the medium (<i>p</i> = 0.043) preference than those with the highest preference. <b><i>Conclusions:</i></b> Individuals who matched with their preferred treatment used less illicit opioids than those who did not during short-term treatment. However, baseline preference for XR-NTX treatment primarily influenced longer term opioid use and treatment adherence.

Psychoeducational Strategies During Outpatient Transition to Extended-Release Naltrexone for Patients With Opioid Use Disorder

2018 ◽  
Vol 25 (4) ◽  
pp. 272-279
Author(s):  
Abigail Zavod ◽  
Sarah C. Akerman ◽  
Martha M. Snow ◽  
Matt Tierney ◽  
Maria A. Sullivan
Keyword(s):  
Treatment Adherence ◽  
Extended Release ◽  
The United States ◽  
Opioid Use Disorder ◽  
Opioid Withdrawal ◽  
Opioid Use ◽  
Major Barrier ◽  
Supportive Interventions ◽  
Outpatient Utilization ◽  
Withdrawal Management

BACKGROUND: The United States is experiencing an opioid epidemic. Better approaches to encourage outpatient utilization of Food and Drug Administration–approved medications for the treatment of opioid use disorder, including extended-release naltrexone (XR-NTX), are needed. Withdrawal management before initiation of XR-NTX is challenging for clinicians and patients and represents a major barrier to treatment. AIMS: To review psychoeducational strategies that support patients during outpatient withdrawal management and transition to XR-NTX. METHOD: We reviewed the literature on psychoeducational strategies used during opioid withdrawal management and described the role that nurses can play in facilitating transition to XR-NTX in a Phase 3, placebo-controlled, outpatient trial comparing induction regimens. RESULTS: Supportive interventions include general psychoeducation on addiction, overcoming ambivalence, treatment adherence, anticipating XR-NTX induction, managing psychological and physiological aspects of opioid withdrawal, risks of opioid use, and sources of support during recovery. CONCLUSIONS: Psychoeducational strategies led by nurses can promote treatment adherence during withdrawal management and induction onto XR-NTX.

scholarly journals Predictors of client retention in a state-based tobacco quitline

2020 ◽  
Vol 15 (2) ◽  
pp. 67-75
Author(s):  
Uma S. Nair ◽  
Brooke Rabe ◽  
Benjamin R. Brady ◽  
Melanie L. Bell
Keyword(s):  
Treatment Adherence ◽  
Tobacco Use ◽  
Standard Care ◽  
Adherence To Treatment ◽  
Client Engagement ◽  
Client Retention ◽  
High Adherence ◽  
Retention In Treatment ◽  
High Treatment

AbstractIntroductionQuitlines are standard care for smoking cessation; however, retaining clients in services is a problem. Little is known about factors that may predict dropout.AimsTo examine predictors of retention while in-program and at follow-up for clients enrolling in a state quitline.MethodsThis was a retrospective analysis of quitline enrolled clients from 2011 to 2017 (N = 49,347). Client retention in-program was categorized as (a) low adherence to treatment (receiving zero coaching calls), moderate (1–2 calls), and high adherence (3+ calls). Dropout at follow-up included participants who were not reached for the 7-month follow-up.ResultsMore than half the sample dropped out during treatment; 61% were not reached for follow-up. Women (odds ratio (OR) = 1.21; 95% confidence interval (CI) = [1.16, 127]) and those with high levels of nicotine dependence (OR = 1.03; 95% CI = [1.02, 1.04]) were more likely to have moderate adherence to treatment (1–2 coaching calls). Dropout at follow-up was more likely among clients who used nicotine replacement therapy (OR = 1.14; 95% CI = [1.09, 1.19]) and less likely among those who had high treatment adherence (OR = 0.41; 95% CI = [0.39, 0.42]).ConclusionGiven the relapsing nature of tobacco use and the harms related to tobacco use, quitlines can improve their impact by offering tailored services to enhance client engagement and retention in-treatment and at follow-up.

FC18-01 - Twelve-month follow-up study of drug treatment in pathological gamblers

2011 ◽  
Vol 26 (S2) ◽  
pp. 1910-1910
Author(s):  
P. Dannon ◽  
M. Kotler
Keyword(s):  
Drug Treatment ◽  
Impulse Control ◽  
Selective Serotonin Reuptake Inhibitors ◽  
Gambling Behavior ◽  
Open Label ◽  
Short Term Treatment ◽  
Addictive Disorders ◽  
Pathological Gamblers ◽  
Wide Range

BackgroundPathological Gambling (PG) is a relatively common and highly disabling impulse control disorder. A range of psychotherapeutic agents including selective serotonin reuptake inhibitors (SSRIs), antiepileptic drugs, and opioid antagonists are shown to be effective in the short-term treatment of PG. The use of a wide range pf pharmacologic treatments for PG is consistent with the observation that PG shares features of obsessive-compulsive spectrum disorders, impulse control disorders, and addictive disorders. The aim of the study is to assess the rate of relapse in treatment-responder pathological gamblers after discontinuation of the active treatment.MethodsThe 43 full -responders were then followed prospectively for an additional 9 months, which included a 3-month open-label continuation phase and a 6-month medication-free, follow-up phase. Raters were blind to the previous drug treatment.ResultsThe majority of patients did not relapse during the 6-month medication- free follow-up phase. Three out of six patients with fluvoxamine, three out of nine with topiramate, seven out of eighteen with bupropion SR, and four out of ten with naltrexone relapsed. Relapse was strictly defined as gambling behavior at any time during the 6-month medication- free follow- up period. Most of the patients did not gamble during the follow- up period, and the patients that did gamble reported a decrease in gambling losses.ConclusionThis naturalistic, long-term follow-up outcome study demonstrates that among pathological gamblers who respond to a six- month trial of medication, the majority of patients appear to maintain full-response during a six-month medication- free follow-up phase.

337 A Multicenter Open-label Pilot Study Evaluating Next-Dose Transition From Zolpidem to Lemborexant: Analysis of Female Subgroup

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A134-A135
Author(s):  
Maha Ahmad ◽  
Manoj Malhotra ◽  
Jess Amchin ◽  
Dinesh Kumar ◽  
Carlos Perdomo ◽  
...  
Keyword(s):  
Pilot Study ◽  
Extended Release ◽  
Open Label ◽  
Titration Period ◽  
Post Hoc ◽  
Dose Change ◽  
Extension Period ◽  
Common Teaes ◽  
Female Subjects

Abstract Introduction Dosing paradigms for transitioning patients to lemborexant (LEM) from zolpidem (ZOL: immediate [IR] or extended-release [ER]) were examined in E2006-A001-312 (Study 312; NCT04009577), an open-label pilot study. Given insomnia prevalence in women, post hoc analyses in female subjects were conducted. Methods Study 312 included: 3-week Screening Period (subjects continued ZOL); 2-week Titration Period (TITR); 12-week Extension Period (EXT); 4-week Follow-up. Adults with insomnia taking ZOL-IR or ZOL-ER intermittently (3–4 nights/week) or frequently (≥5 nights/week) were enrolled. Subjects with intermittent, or one week each of intermittent and frequent ZOL use, were assigned to Cohort-1 and started TITR with LEM 5mg (LEM5). Frequent ZOL users (Cohort-2) were randomized 1:1 to LEM5 (Cohort-2A) or LEM 10mg (LEM10; Cohort-2B). Subjects who transitioned to LEM could opt into EXT. Subjects could change LEM dose during TITR (only once) and during EXT. The primary endpoint was the proportion of subjects who transitioned to LEM at end of TITR. Treatment-emergent adverse events (TEAEs) were assessed by dose at time of TEAE. Results Overall, 35 subjects were female and 29/35 (82.9%) transitioned to LEM. In Cohort-1, 7 subjects began TITR; all transitioned to LEM (5 subjects ended TITR on LEM5; 2 ended on LEM10). In Cohort-2A, 14 subjects began TITR with LEM5; 12/14 (85.7%) transitioned (6 subjects each ended TITR on LEM5 or LEM10). In Cohort-2B, 14 subjects began TITR with LEM10; 10/14 (71.4%) transitioned to LEM (3 subjects ended TITR on LEM5 and 7 on LEM10). All 29 transitioned subjects opted into EXT, and 27/29 (93.1%) completed the study. Based on modal dose (most frequent dose taken during TITR and EXT combined) groups, median time to first dose change during EXT was 14.5 and 17.0 days for LEM5 and LEM10, respectively. Overall, most TEAEs were mild/moderate in severity. Across TITR and EXT, more TEAEs occurred with LEM10 than with LEM5; the most common TEAEs were somnolence (n=3) and abnormal dreams (n=3). Conclusion Most female subjects successfully transitioned from intermittent or frequent ZOL-IR/ZOL-ER use to LEM and completed the study. LEM was generally well tolerated. The safety profile was consistent with that observed in Phase 3 studies. Support (if any) Eisai Inc.

Levetiracetam extended release for the treatment of patients with partial-onset seizures: A long-term, open-label follow-up study

2016 ◽  
Vol 120 ◽  
pp. 7-12 ◽  
Author(s):  
Steve Chung ◽  
Hugo Ceja ◽  
Jacek Gawłowicz ◽  
Cindy McShea ◽  
Jimmy Schiemann ◽  
...  
Keyword(s):  
Extended Release ◽  
Open Label ◽  
Follow Up Study

Evaluation of Treatment Adherence of Sickle Cell Pediatric patients in Use of hydroxyurea

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 4757-4757
Author(s):  
Celia M. Campanaro ◽  
Annemeri Livinalli ◽  
Debora Lourenço Souza ◽  
Vanessa Rocha Varizano ◽  
Heder Frank Gianotto Estrela
Keyword(s):  
Sickle Cell Disease ◽  
Treatment Adherence ◽  
Sickle Cell ◽  
Pediatric Patients ◽  
Adherence Rate ◽  
Cell Disease ◽  
Good Adherence ◽  
Short Period ◽  
The Impact

Abstract Abstract 4757 Background: Sickle cell disease is a genetic and chronic disease prevalent in Brazil. It is believed that about 2500 to 3000 brazilians born a year with sickle cell disease. The most common clinical complication is the vessel occlusive crisis, the blockade of microcirculation, sickling of red blood cells, local hypoxia and ischemia of tissues, resulting in acute painful crises. To control this situation, treatment with analgesics, red blood cell transfusion and hydroxyurea (HU) are recommended.The HU administration has shown excellent results through the significant increase in the hemoglobin F levels, thus contributing to decrease in vessel occlusive crises, reducing the frequency of transfusion and potentially preventing organ damage. The treatment adherence is crucial to maintain the serum level of the drug and achieve the best therapeutic results. Adherence is defined as degree of agreement between the person's behavior in relation to guidance provided by physician or other healthcare professional.Several factors influence adherence and understand them allows the professional to develop tools to assist the patient in understanding its importance.The purpose of this study was to quantify the adherence to treatment with HU and identify related causes to non-adherence in pediatric patients with sickle cell disease. METHODS: quantitative, descriptive and retrospective study involving pediatric patients 3 to 18 years seen at GRENDACC- Jundiai-SP.The information was obtained from a questionnaire applied to 19 caregivers and pharmacotherapeutic follow-up recording form (PH) available at the pharmacy for the period from may/2010 to september/2010.PH served as an instrument to measure adherence by the method pill count. Each patient has a form that is filled with information: date and amount of medication dispensed and dosage.At each visit to pharmacy, the caregiver has the bottle for refill and pill count.During the research, the form provided information to apply the formula to verify the adherence rate: quantify dispensed – number on the bottle/treatment period × 100.It was considered a good adherence who have demonstrated a adherence rate of ≥ 90%. RESULTS: The caregivers were represented mostly by mothers (68%).The caregiver's educational level varied from illiterate (1/19), complete or incomplete elementary (10/19), complete or incomplete secondary (7/19) and university (1/19). Asked about the administration of HU, 95% of caregivers reported giving the medication in correct schedule and 42% forgot to give the medicine sometime during the treatment, the reason was accumulation of tasks and concerns with other family members. In the evaluation of adherence 17 PH were viable and showed that 58.8% (10/17) of patients had an rate ≥90%. The lowest rate was 63% and ocurred in only 1 patient. CONCLUSIONS: Although there is no consensus regarding the optimal rate to consider a good adherence, the papers present that rates below 80% is worrying and needs intervention. In the group evaluated, 82% presented more than 80% adherence. Pharmacotherapeutic follow-up allows rapid detection of drug related problems, with immediate intervention through guidance, and if necessary, medical or psychosocial intervention. Although there are few studies about this issue in pediatric patient, the small group of subjects studied and the short period of assessment, we believe the results support the importance of a rigorous monitoring pharmacotherapeutic by visits to pharmacy to follow-up consultations. We suggest further studies with a larger sample and longer period to confirm the importance of monitoring pharmacotherapeutic tool in improving the adherence, evaluate the impact and variables that affect the non-adherence. Disclosures: No relevant conflicts of interest to declare.

335 Evaluation of Dose Transition From Zolpidem to Lemborexant Across 14 Weeks: Results From a Multicenter Open-label Pilot Study

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A134-A134
Author(s):  
Russell Rosenberg ◽  
Jess Amchin ◽  
Dinesh Kumar ◽  
Carlos Perdomo ◽  
Norman Atkins ◽  
...  
Keyword(s):  
Pilot Study ◽  
Extended Release ◽  
Open Label ◽  
Phase 3 ◽  
Titration Period ◽  
Study Results ◽  
Dose Change ◽  
Extension Period ◽  
Common Teaes

Abstract Introduction E2006-A001-312 (Study 312; NCT04009577) was an open-label pilot study that examined pre-specified dosing paradigms for transitioning patients from zolpidem (ZOL: immediate [IR] or extended-release [ER]) to the dual orexin receptor antagonist lemborexant (LEM; 5mg [LEM5] or 10mg [LEM10]). Methods Study 312 included a 3-week Screening Period (subjects continued ZOL), 2-week Titration Period (TITR), 12-week Extension Period (EXT), and 4-week Follow-up Period. Adults with insomnia who were intermittent (3–4 nights/week) or frequent (≥5 nights/week) ZOL-IR or ZOL-ER users participated. Intermittent ZOL users and subjects with one week each of intermittent and frequent ZOL usage were assigned to Cohort-1 and began TITR with LEM5. Frequent ZOL users were assigned to Cohort-2 and randomized 1:1 to LEM5 or LEM10. Subjects who successfully transitioned to LEM had the option to enter EXT. During TITR and EXT, subjects could change LEM dose (only once during TITR). The primary endpoint was the proportion of subjects who transitioned to LEM at the end of TITR. Treatment-emergent adverse events (TEAEs) were assessed based on dose at time of TEAE. Results Fifty-three subjects enrolled (Cohort-1, n=10; Cohort-2, n=43). Of these, 43/53 (81.1%) transitioned to LEM at the end of TITR; all 43 (100.0%) entered EXT wherein 41/43 subjects received treatment. Three of these subjects discontinued treatment during EXT, so that 38/41 (92.7%) subjects entered EXT, received treatment and completed EXT. At the end of EXT, 25/41 (61.0%) subjects were receiving LEM10 and 16/41 (39.0%) were receiving LEM5. Based on modal dose (most frequent dose taken during TITR and EXT combined) groups, median time to first dose change was 14.5 days and 36.0 days for LEM5 and LEM10, respectively. The majority of TEAEs were mild/moderate in severity. Across the study (TITR and EXT), more TEAEs occurred with LEM10 than LEM5; the most common TEAEs were somnolence (n=4) and abnormal dreams (n=4). Conclusion Study results support the view that patients can successfully transition directly from ZOL to LEM. LEM was generally well tolerated; the safety profile was consistent with that observed in Phase 3 clinical development. Support (if any) Eisai Inc.

Compliance therapy in patients with chronic heart failure: a review

2011 ◽  
Vol 6 (1) ◽  
pp. 240
Author(s):  
Maria Fernanda de Oliveira Carvalho ◽  
João Carlos Alchieri
Keyword(s):  
Heart Failure ◽  
Chronic Heart Failure ◽  
Treatment Adherence ◽  
Psychological Assessment ◽  
Patient Adherence ◽  
Adherence To Treatment ◽  
Disease Characteristics ◽  
Compliance Behavior ◽  
Insuficiencia Cardiaca

ABSTRACTObjective: to check which instruments have been used in psychological assessment of treatment adherence, the indicators have shown the results from these instruments for research and evaluation of this aspect, as well as reflect on the applicability of the practice of the psychologist. Method: this integrative review is performed in the Portal Periodicos Capes, using the keywords adherence, instruments and chronic heart failure and correlates in English. Results: poor adherence to treatment may be associated with several factors, from socioeconomic, psychological disorders and cognitive impairment until the disease characteristics and complexity of treatment, the relationship between health professional and patient, however, is one of the factors contributing to treatment adherence. Conclusion: some authors have sought to present methods to assess adherence to treatment, including psychological tests and inventories, but there are a limited number of investigations in this direction. It is known that the compliance behavior involves many different factors, which requires thorough investigation by means of psychological assessment, to identify those which favor or hinder the appropriate follow-up treatment, and promote greater understanding of both the healthcare staff as to patient, allowing for intervention strategies. Descriptors: heart failure; patient adherence; treatment.RESUMOObjetivo: verificar quais instrumentos psicológicos vêm sendo utilizados na avaliação da aderência terapêutica, apresentar os indicadores evidenciados nos resultados provenientes de tais instrumentos para investigação e avaliação deste aspecto, bem como refletir acerca da aplicabilidade destes na prática de atuação do psicólogo. Método: trata-se de revisão integrativa realizada no portal Periódicos Capes, utilizando-se os descritores aderência, instrumentos e insuficiência cardíaca crônica, bem como os correlatos em língua inglesa. Resultados: a baixa adesão ao tratamento pode estar associada a diversos fatores, desde problemas socioeconômicos, distúrbios psicológicos, e prejuizos cognitivos, até as características da doença e a complexidade do tratamento; o relacionamento entre o profissional de saude e o paciente, em contrapartida, é um dos fatores que contribui à adesão ao tratamento. Conclusão: alguns autores vêm buscando apresentar métodos que avaliem a adesão ao tratamento incluindo testes e inventários psicológicos, porém há um número limitado de investigação nesse sentido. Sabe-se que o comportamento aderente envolve muitos e diferentes fatores, o que requer investigação aprofundada por meio da avaliação psicológica, no sentido de identificar quais destes favorecem ou dificultam o seguimento adequado do tratamento, e promover maior conhecimento tanto à equipe de saude quanto ao paciente, possibilitando estratégias de intervenção. Descritores: insuficiência cardíaca; adesão do paciente; tratamento.RESUMENObjetivo: comprobar que instrumentos psicológicos han sido utilizados en la evaluación de la adherencia al tratamiento, presente los indicadores que se evidencia en los resultados de estos instrumentos para la investigación y la evaluación de este aspecto, así como reflexionar sobre la aplicabilidad destas en la práctica del psicólogo. Método: se trata de un revisión integradora celebrada en el Portal Periodicos Capes, utilizando los descriptores la adhesión, los instrumentos y la insuficiencia cardiaca crónica y se correlaciona en inglés. Resultados: la mala adherencia al tratamiento puede estar asociado con varios factores, desde socioeconómica, trastornos psicológicos y deterioro cognitivo hasta la características de la enfermedad y la complejidad del tratamento; la relación entre el profesional de la salud y el paciente, sin embargo, es uno de los factores que contribuyen a la adherencia al tratamiento. Conclusión: algunos autores han tratado de presentar los métodos para evaluar la adherencia al tratamiento, incluyendo las pruebas psicológicas y los inventarios, pero hay un número limitado de investigaciones en esta dirección. Se sabe que el comportamiento de cumplimiento implica muchos factores diferentes, lo que requiere una investigación a fondo por medio de la evaluación psicológica, para identificar los que favorecen o dificultan la comprensión de un seguimiento adecuado del tratamiento, y promover una mayor conocimiento tanto del personal médico en cuanto a paciente, teniendo en cuenta las estrategias de intervención. Descriptores: insuficiencia cardíaca; adhesión del paciente; el tratamiento.

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