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1.
Clin Infect Dis ; 78(3): 582-590, 2024 03 20.
Artículo en Inglés | MEDLINE | ID: mdl-37992203

RESUMEN

BACKGROUND: We aimed to evaluate the efficacy of opportunistic treatment of hepatitis C virus (HCV) infection among hospitalized people who inject drugs (PWID). METHODS: We performed a pragmatic, stepped wedge cluster randomized trial recruiting HCV RNA positive individuals admitted for inpatient care in departments of internal medicine, addiction medicine, and psychiatry at three hospitals in Oslo, Norway. Seven departments were sequentially randomized to change from control conditions (standard of care referral to outpatient care) to intervention conditions (immediate treatment initiation). The primary outcome was treatment completion, defined as dispensing the final package of the prescribed treatment within six months after enrolment. RESULTS: A total of 200 HCV RNA positive individuals were enrolled between 1 October 2019 and 31 December 2021 (mean age 47.4 years, 72.5% male, 60.5% injected past 3 months, 20.4% cirrhosis). Treatment completion was accomplished by 67 of 98 (68.4% [95% confidence interval {CI}: 58.2-77.4]) during intervention conditions and by 36 of 102 (35.3% [95% CI: 26.1-45.4]) during control conditions (risk difference 33.1% [95% CI: 20.0-46.2]; risk ratio 1.9 [95% CI: 1.4-2.6]). The intervention was superior in terms of treatment completion (adjusted odds ratio [aOR] 4.8 [95% CI: 1.8-12.8]; P = .002) and time to treatment initiation (adjusted hazard ratio [aHR] 4.0 [95% CI: 2.5-6.3]; P < .001). Sustained virologic response was documented in 60 of 98 (61.2% [95% CI: 50.8-70.9]) during intervention and in 66 of 102 (64.7% [95% CI: 54.6-73.9]) during control conditions. CONCLUSIONS: An opportunistic test-and-treat approach to HCV infection was superior to standard of care among hospitalized PWID. The model of care should be considered for broader implementation. Clinical Trials Registration. NCT04220645.


Asunto(s)
Consumidores de Drogas , Hepatitis C Crónica , Hepatitis C , Abuso de Sustancias por Vía Intravenosa , Femenino , Humanos , Masculino , Persona de Mediana Edad , Antivirales/uso terapéutico , Hepacivirus/genética , Hepatitis C/tratamiento farmacológico , Hepatitis C Crónica/tratamiento farmacológico , ARN , Abuso de Sustancias por Vía Intravenosa/complicaciones , Abuso de Sustancias por Vía Intravenosa/tratamiento farmacológico
2.
Contemp Clin Trials ; 135: 107360, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37865138

RESUMEN

BACKGROUND AND OBJECTIVE: First study to assess any compensatory increase in use of non-opioid illicit substances and alcohol in opioid dependent patients randomized to treatment with extended-release naltrexone (XR-NTX) or buprenorphine-naloxone (BP-NLX) and in longer term treatment with extended-release naltrexone. METHOD: A multicenter, outpatient, open-label randomized clinical trial where patients received intramuscular extended-release naltrexone hydrochloride, 380 mg/month, or daily sublingual buprenorphine-naloxone 8-24/2-6 mg for 12 weeks, and an option to continue with extended-release naltrexone for an additional 36 week follow-up. The study was conducted at five urban addiction clinics and detoxification units in Norway between November 2012, and July 2016. RESULTS: Among the 143 patients, 106 men and 37 women, there were no significant differences between those randomized to XR-NTX or BP-NLX in the risk of first relapse to alcohol (HR 1.31; 0.68-2.53), amphetamines (HR 0.88; 0.43-1.80), benzodiazepines (HR 1.24; 0.74-2.09) or cannabis (HR 1.55; 0.83-2.89). Also in the 36-week (12-48 weeks) follow-up period we found no significant differences between patients continuing with XR-NTX compared to those switching to XR-NTX after the randomized period in risk of first relapse to any non-opioid substance. In both study periods, the mean time in the study were longer among those relapsing to non-opioid addictive substances than those who did not. There was no significant association between first relapse to illicit opioids and first relapse to non-opioid addictive substances. CONCLUSION: There was no increase in the risk of relapse to non-opioid addictive substances neither in short term nor longer-term treatment with extended-release naltrexone. Trial registrationclinicaltrials.gov Identifier: NCT01717963.


Asunto(s)
Buprenorfina , Trastornos Relacionados con Opioides , Masculino , Humanos , Femenino , Antagonistas de Narcóticos/uso terapéutico , Naltrexona/uso terapéutico , Combinación Buprenorfina y Naloxona/uso terapéutico , Analgésicos Opioides/uso terapéutico , Trastornos Relacionados con Opioides/tratamiento farmacológico , Enfermedad Crónica , Recurrencia , Preparaciones de Acción Retardada/uso terapéutico , Inyecciones Intramusculares
3.
Heliyon ; 9(7): e17516, 2023 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-37449176

RESUMEN

Background and aims: Recovery from substance use disorders (SUD) has traditionally been equated with abstinence. "Personal recovery" however emphasizes recovery as a unique and personal process, supported by changes in connectedness, hope, identity, meaning and empowerment. This study aimed to examine personal recovery in people receiving extended-release naltrexone (XR-NTX); specifically investigate changes in personal recovery during treatment, identify groups of participants following distinct trajectories of recovery, and characteristics predicting group-belonging. Methods: Overall change in recovery (Questionnaire about the Process of Recovery, QPR) score was assessed by linear mixed model in a subsample of 135 people with opioid use disorder (OUD) participating in a 24 + 28-week trial of XR-NTX. Growth mixture model was used to identify potential groups of people following distinct trajectories of personal recovery. Results: Overall, there was a significant change in QPR score during treatment. Four groups with distinct recovery trajectories were identified: "initially low- increase" (G1), "initially average- no change" (G2), "initially high- no change" (G3) and "initially high- increase" (G4). The groups were different with regards to level of psychological distress, social support, and the use of benzodiazepines. In addition, previous participation in opioid agonist treatment programs, current pain, life satisfaction, employment, heroin craving and previous use of heroin also differed between groups. Conclusions: Personal recovery among people receiving XR-NTX follows different trajectories, and various factors are associated with personal recovery. Particular attention regarding psychological distress, social support and heroin use among patients commencing XR-NTX treatment is important to facilitate successful recovery trajectories.

4.
Addict Behav Rep ; 17: 100488, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-37077505

RESUMEN

Aim: To investigate the association of adverse childhood experiences (ACEs) and substance use disorders (alcohol and illicit drug use disorders), specifically by gender, in a large longitudinal non-clinical population study. Methods: Data from 8199 adolescents, first assessed for ACE (2006-2008), were linked with subsequent data from the Norwegian Patient Register to obtain diagnoses of a substance use disorder in adulthood (after 12-14 years' follow-up in March 2020). This study used logistic regression analysis to assess the associations between ACEs and substance use disorders with respect to gender. Results: Adults with any history of ACEs have a 4.3-fold higher likelihood of developing a substance use disorder. Female adults had a 5.9-fold higher likelihood of developing an alcohol use disorder. Emotional neglect, sexual abuse and physical abuse were the strongest individual ACE predictors for this association. Male adults had a 5.0-fold higher likelihood of developing an illicit drug use disorder (for example stimulants such as cocaine, inhibiter such as opioids, cannabinoids and multiple drugs). Physical abuse, parental divorce and witnessed violence were the strongest individual ACE predictors for this association. Conclusions: This study reinforces the association between ACEs and substance use disorders and exposes a gender-specific pattern. Increased attention should be paid to the meaning of individual ACEs as well as to the accumulation of ACEs in the development of a substance use disorder.

5.
Artículo en Inglés | MEDLINE | ID: mdl-36141709

RESUMEN

Previous studies have indicated elevated levels of impulsivity, hyperactivity, and inattention (IHI) among opioid-dependent patients seeking outpatient treatment with extended-release naltrexone (XR-NTX). This led us to hypothesize that IHI may be associated with a higher discontinuation rate for XR-NTX treatment. In a group of 162 patients with opioid dependence, discontinuation prior to the full 24 weeks of the study period (six injections and attending the study visit at 24 weeks) occurred in 49% of the patients, primarily in the early stage of treatment. IHI above the clinical cut-off on the adult ADHD self-report scale (ASRS) was not associated with a risk of premature discontinuation. This finding was not altered when controlling for socio-demographics, substance, use and mental health severity. Conclusively, high levels of IHI per se is not contradictive for XR-NTX treatment in regard to concern for premature discontinuation.


Asunto(s)
Naltrexona , Trastornos Relacionados con Opioides , Adulto , Analgésicos Opioides/uso terapéutico , Preparaciones de Acción Retardada/uso terapéutico , Humanos , Conducta Impulsiva , Inyecciones Intramusculares , Naltrexona/efectos adversos , Naltrexona/uso terapéutico , Antagonistas de Narcóticos/uso terapéutico , Trastornos Relacionados con Opioides/tratamiento farmacológico
6.
Addict Sci Clin Pract ; 17(1): 36, 2022 07 18.
Artículo en Inglés | MEDLINE | ID: mdl-35850782

RESUMEN

BACKGROUND: The opioid antagonist extended-release naltrexone (XR-NTX) in the treatment of opioid use disorder (OUD) is effective in terms of safety, abstinence from opioid use and retention in treatment. However, it is unclear how patients experience and adjust to losing the possibility of achieving an opioid effect. This qualitative study is the first to explore how people with opioid dependence experience XR-NTX treatment, focusing on the process of treatment over time. METHODS: Using a purposive sampling strategy, semi-structured interviews were undertaken with 19 persons with opioid use disorder (15 men, four women, 22-55 years of age) participating in a clinical trial of XR-NTX in Norway. The interviewees had received at least three XR-NTX injections. Qualitative content analysis with an inductive approach was used. FINDINGS: Participants described that XR-NTX treatment had many advantages. However they still faced multiple challenges, some of which they were not prepared for. Having to find a new foothold and adapt to no longer gaining an effect from opioids due to the antagonist medication was challenging. This was especially true for those struggling emotionally and transitioning into the harmful use of non-opioid substances. Additional support was considered crucial. Even so, the treatment led to an opportunity to participate in society and reclaim identity. Participants had strong goals for the future and described that XR-NTX enabled a more meaningful life. Expectations of a better life could however turn into broken hopes. Although participants were largely optimistic about the future, thinking about the end of treatment could cause apprehension. CONCLUSIONS: XR-NTX treatment offers freedom from opioids and can facilitate the recovery process for people with OUD. However, our findings also highlight several challenges associated with XR-NTX treatment, emphasizing the importance of monitoring emotional difficulties and increase of non-opioid substances during treatment. As opioid abstinence in itself does not necessarily equal recovery, our findings underscore the importance of seeing XR-NTX as part of a comprehensive, individualized treatment approach. TRIAL REGISTRATION: Clinicaltrials.gov # NCT03647774, first Registered: Aug 28, 2018.


Asunto(s)
Naltrexona , Trastornos Relacionados con Opioides , Adulto , Analgésicos Opioides/uso terapéutico , Preparaciones de Acción Retardada/uso terapéutico , Femenino , Humanos , Inyecciones Intramusculares , Masculino , Persona de Mediana Edad , Naltrexona/uso terapéutico , Antagonistas de Narcóticos/uso terapéutico , Trastornos Relacionados con Opioides/tratamiento farmacológico , Adulto Joven
7.
Eur Addict Res ; 28(1): 56-67, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-34569487

RESUMEN

BACKGROUND: 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. OBJECTIVES: We aimed to test the relationship between baseline preference for XR-NTX and adherence to treatment, use of illicit opioids, and risk of relapse. METHODS: 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. RESULTS: 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 (p < 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, p = 0.013). Opioid use was significantly higher among participants who switched to XR-NTX with the lowest preference than the medium (p = 0.003) or the highest (p = 0.001) preference. The risk of relapse to opioids, however, was significantly higher among XR-NTX continuing participants with the lowest (p = 0.002) or the medium (p = 0.043) preference than those with the highest preference. CONCLUSIONS: 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.


Asunto(s)
Naltrexona , Trastornos Relacionados con Opioides , Adulto , Analgésicos Opioides/uso terapéutico , Preparaciones de Acción Retardada/uso terapéutico , Humanos , Inyecciones Intramusculares , Masculino , Naltrexona/uso terapéutico , Antagonistas de Narcóticos/uso terapéutico , Trastornos Relacionados con Opioides/tratamiento farmacológico , Recurrencia , Cumplimiento y Adherencia al Tratamiento
8.
J Subst Abuse Treat ; 135: 108656, 2022 04.
Artículo en Inglés | MEDLINE | ID: mdl-34774396

RESUMEN

INTRODUCTION: Life satisfaction (LS) in opioid-dependent individuals is lower than in the general population. This study aimed to explore changes in LS during short- and long-term treatment with extended-release naltrexone (XR-NTX). METHODS: This open-label 12-week clinical trial randomized 159 participants to either monthly XR-NTX or daily buprenorphine-naloxone (BP-NLX). In a subsequent 36-week follow-up study on XR-NTX, participants either continued or switched to XR-NTX. The study collected data on the Temporary Satisfaction with Life (TSWL) and illicit opioid use every fourth week. The research team assessed changes in TSWL by a linear mixed model and growth mixture model. The study assessed relationship between opioid use and TSWL by a linear mixed model. RESULTS: Change in LS differed significantly between the groups in both study periods. TSWL scores were significantly higher in the XR-NTX group at week 4 (p = 0.013) and week 8 (p = 0.002). In the follow-up period, the groups were significantly different only at week 16 (p = 0.031) and week 48 (p = 0.025), with the higher TSWL scores in the XR-NTX continued group. Increase in opioid use by one day was associated with a 0.12 point lower mean TSWL score. Both study periods identified groups with low and high LS levels. In the trial period, the TSWL scores exhibited a significant increase from baseline to week 12 in both groups, p < 0.001 and p = 0.011 in the low and high LS group, respectively. In the follow-up period, the TSWL scores exhibited a significant increase from week 16 to week 48 (p = 0.003) in the high LS group, while the low LS group showed persistently lower values throughout that period. CONCLUSIONS: XR-NTX treatment given once monthly is associated with higher LS, as measured by TSWL, compared to daily use of BP-NLX. The majority of the participants had relatively low TSWL scores and did not report any change in TSWL during longer-term treatment. The study found a significant association between more frequent illicit opioid use and a low or decreased LS during follow-up.


Asunto(s)
Naltrexona , Trastornos Relacionados con Opioides , Preparaciones de Acción Retardada/uso terapéutico , Estudios de Seguimiento , Humanos , Inyecciones Intramusculares , Naltrexona/uso terapéutico , Antagonistas de Narcóticos/uso terapéutico , Trastornos Relacionados con Opioides/tratamiento farmacológico , Trastornos Relacionados con Opioides/epidemiología , Satisfacción Personal
9.
J Subst Abuse Treat ; 136: 108667, 2022 05.
Artículo en Inglés | MEDLINE | ID: mdl-34865937

RESUMEN

BACKGROUND: Extended-release naltrexone (XR-NTX), an opioid antagonist, has demonstrated equal treatment outcomes, in terms of safety, opioid use, and retention, to the recommended OMT medication buprenorphine. However, premature discontinuation of XR-NTX treatment is still common and poorly understood. Research on patient experiences of XR-NTX treatment is limited. We sought to explore participants' experiences with discontinuation of treatment with XR-NTX, particularly motivation for XR-NTX, experiences of initiation and treatment, and rationale for leaving treatment. METHODS: We conducted qualitative, semi-structured interviews with participants from a clinical trial of XR-NTX. The study participants (N = 13) included seven women and six men with opioid dependence, who had received a minimum of one and maximum of four injections of XR-NTX. The study team analyzed transcribed interviews, employing thematic analysis with a critical realist approach. FINDINGS: The research team identified three themes, and we present them as a chronological narrative: theme 1: Entering treatment - I thought I knew what I was going into; theme 2: Life with XR-NTX - I had something in me that I didn't want; and theme 3: Leaving treatment - I want to go somewhere in life. Patients' unfulfilled expectations of how XR-NTX would lead to a better life were central to decisions about discontinuation, including unexpected physical, emotional, or mental reactions as well as a lack of expected effects, notably some described an opioid effect from buprenorphine. A few participants ended treatment because they had reached their treatment goal, but most expressed disappointment about not achieving this goal. Some also expressed renewed acceptance of OMT. The participants' motivation for abstinence from illegal substances generally remained. CONCLUSION: Our findings emphasize that a dynamic understanding of discontinuation of treatment is necessary to achieve a long-term approach to recovery: the field should understand discontinuation as a feature of typical treatment trajectories, and discontinuation can be followed by re-initiation of treatment.


Asunto(s)
Buprenorfina , Trastornos Relacionados con Opioides , Analgésicos Opioides/uso terapéutico , Buprenorfina/uso terapéutico , Estudios Clínicos como Asunto , Preparaciones de Acción Retardada/uso terapéutico , Femenino , Humanos , Inyecciones Intramusculares , Masculino , Naltrexona/uso terapéutico , Antagonistas de Narcóticos/uso terapéutico , Trastornos Relacionados con Opioides/tratamiento farmacológico , Investigación Cualitativa
10.
J Clin Med ; 10(19)2021 Sep 30.
Artículo en Inglés | MEDLINE | ID: mdl-34640572

RESUMEN

The level of impulsivity, hyperactivity, and inattention (IHI) is higher among patients with substance use disorder (SUD) than in the general population. However, the prevalence of such symptoms in patients seeking treatment with an opioid antagonist, such as extended-release naltrexone (XR-NTX), is unknown. We screened 162 patients with opioid use disorder (OUD) seeking treatment with XR-NTX in Norway using the Adult ADHD Self-Report Scale (ASRS) to estimate the prevalence of IHI alongside an assessment of mental and physical health and substance use. Sixty-six patients scored above the clinical cut-off on the ASRS. Higher levels of IHI were significantly associated with a longer history of frequent amphetamine use, current alcohol use, and greater mental distress. Mental distress was the strongest factor associated with higher levels of IHI. The introduction of screening for IHI and mental distress in opioid maintenance treatment and XR-NTX would likely improve the quality of care and enable clinicians to tailor interventions to the needs of patients with high levels of IHI to prevent treatment discontinuation.

11.
Am J Addict ; 30(5): 453-460, 2021 09.
Artículo en Inglés | MEDLINE | ID: mdl-34487395

RESUMEN

BACKGROUND AND OBJECTIVES: Compare the risk of relapse to heroin and other illicit opioids among opioid-dependent patients receiving treatment with extended-release naltrexone (XR-NTX) or buprenorphine-naloxone (BP-NLX). METHODS: Re-analyzed data from a 12-week multicenter, open-label, randomized treatment study with a subsequent 36-week open-label follow-up study. All patients, N = 143, had completed detoxification and received at least one dose of study medication. RESULTS: Of 143 patients (72% men), mean age 36 years, 71 received XR-NTX and 72 BP-NLX. The risk of first relapse and the risk of any relapse to heroin and other illicit opioids were both significantly lower in the XR-NTX group compared with the BP-NLX group (hazard ratio [HR], 0.46; 95% confidence interval [CI], 0.28-0.76; P = .002, and HR, 0.11; 95% CI, 0.04-0.29; P < .001, respectively) and (HR, 0.15; 95% CI, 0.09-0.27; P < .001 and HR, 0.05; 95% CI, 0.03-0.09; P < .001, respectively). There was a stable low risk of relapse among participants receiving XR-NTX in the follow-up. DISCUSSION AND CONCLUSIONS: Compared to BP-NLX, patients on XR-NTX had a substantially reduced risk of relapse to illicit opioids and showed a stable low risk of relapse over time in longer-term treatment. SCIENTIFIC SIGNIFICANCE: Our data support XR-NTX as a first-line treatment option for patients with opioid addiction both in short and longer-term treatment. This is the first European study showing that XR-NTX significantly reduces the risk of first and any relapse to heroin use in opioid-dependent patients compared to BP-NLX. Our data contradict previous data from the X:BOT study, showing no significant difference in relapse risk between the groups in a 6-month randomised controlled trial. (© 2021 Authors. The American Journal on Addictions published by Wiley Periodicals LLC on behalf of The American Academy of Addiction Psychiatry). (Am J Addict 2021;30:451-458).


Asunto(s)
Combinación Buprenorfina y Naloxona , Trastornos Relacionados con Opioides , Adulto , Analgésicos Opioides/uso terapéutico , Combinación Buprenorfina y Naloxona/uso terapéutico , Preparaciones de Acción Retardada/uso terapéutico , Femenino , Estudios de Seguimiento , Humanos , Inyecciones Intramusculares , Masculino , Naltrexona/uso terapéutico , Antagonistas de Narcóticos/uso terapéutico , Trastornos Relacionados con Opioides/tratamiento farmacológico , Recurrencia
12.
Am J Addict ; 30(4): 366-375, 2021 07.
Artículo en Inglés | MEDLINE | ID: mdl-33738870

RESUMEN

BACKGROUND AND OBJECTIVES: Chronic pain is not well understood in opioid-dependent populations. We report the prevalence of chronic pain and pain characteristics in an opioid-dependent population by treatment type and gender. METHODS: This cross-sectional study opportunistically recruited 569 patients (32% women) receiving treatment for opioid use disorder (DSM-5) in Norway during 2016-2018 (83% received opioid maintenance treatment, 17% received treatment without medication). We asked about chronic pain (≥3 months; ICD-11), pain severity (NRS-11), and other pain characteristics. RESULTS: Overall, 55% reported chronic pain (≥3 months), with a higher prevalence among women (61% vs 52%, P = .041) and patients receiving methadone (66%) compared with buprenorphine or no medication (46% and 45%, P < .001). Chronic pain was associated with higher age (P < .001) and higher doses of methadone (P = .048). The average duration of pain was 11 years. The most frequently reported pain locations were the lower extremities (59%) and the back (54%), and 69% reported more than one pain location. Constant pain and migrating pain were significantly associated with both moderate (adjusted odds ratio [aOR]: 2.04, confidence interval [CI]: 1.12-3.74 and aOR: 2.44, CI: 1.09-5.43) and severe pain intensity (aOR: 2.08, CI: 1.14-3.80 and aOR: 2.46, CI: 1.10-5.47). Reporting no effect of analgesics was associated with severe pain intensity (aOR: 0.54, CI: 0.29-0.99). CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: Over half reported chronic pain, and rates were highest among women and patients receiving methadone. New contributions to the field are descriptions of pain characteristics by gender and pain severity, and interactions between medication type and age. (© 2021 The Authors. The American Journal on Addictions published by Wiley Periodicals LLC on behalf of The American Academy of Addiction Psychiatry). (Am J Addict 2021;00:00-00).


Asunto(s)
Dolor Crónico/epidemiología , Trastornos Relacionados con Opioides/tratamiento farmacológico , Trastornos Relacionados con Opioides/epidemiología , Adolescente , Adulto , Buprenorfina/uso terapéutico , Estudios Transversales , Femenino , Humanos , Masculino , Metadona/uso terapéutico , Persona de Mediana Edad , Noruega/epidemiología , Tratamiento de Sustitución de Opiáceos/estadística & datos numéricos , Prevalencia , Adulto Joven
13.
Addiction ; 2020 Dec 18.
Artículo en Inglés | MEDLINE | ID: mdl-33338285

RESUMEN

BACKGROUND AND AIM: Extended-release naltrexone (XR-NTX) is an underused treatment option for opioid dependence, today only available in a few countries in the world. Although effective, safe and feasible in short-term treatment, long-term data are scarce and there is no recommendation for required treatment length. The aims of the study were to determine the perceived need of long-term XR-NTX treatment and to examine long-term treatment outcomes. DESIGN: In this prospective cohort study, following a parent 1-year study of XR-NTX, participants received treatment with XR-NTX at their own discretion for a maximum of 104 weeks. SETTING: Five urban, outpatient addiction clinics in Norway. PARTICIPANTS: Opioid-dependent adults 18-60 years old (n=50) already participating in the parent study. INTERVENTION: XR-NTX administrated as intra-muscular injections (380 mg) every 4 weeks. MEASUREMENTS: Time in the study, use of opioids and other illicit substances, opioid craving, and treatment satisfaction reported every 4 weeks. FINDINGS: Among 58 participants who completed the 1-year parent study, 50 chose to continue the treatment with XR-NTX. Median prolonged treatment time was 44.0 weeks (95% CI: 25.5-62.5), ranging from 8 to 104 weeks. Most participants (35, 70%) reported no relapse to opioid use during treatment while a subgroup (15, 30%) reported relapses to opioids during the study. Scores for mean treatment satisfaction and recommending treatment to others were very high (>9) and mean opioid craving score was very low (<1) on a scale ranging from 0 to 10. CONCLUSIONS: Extended-release naltrexone (XR-NTX) was well tolerated in long-term treatment of opioid dependent individuals in Norway already in XR-NTX treatment. On average, the participants chose to continue treatment for almost 1 year beyond the initial 9 to 12 months of treatment. Participants reported high treatment satisfaction and 70% showed no relapse to opioids during the treatment period.

14.
Front Psychol ; 11: 443, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32265780

RESUMEN

BACKGROUND: A defined goal in mental health care is to increase the opportunities for patients to more actively participate in their treatment. This goal includes integrating aspects of user empowerment and shared decision-making (SDM) into treatment courses. To achieve this goal, more knowledge is needed about how patients and therapists perceive this integration. OBJECTIVE: To explore patient experiences of SDM, to describe differences between patient and therapist experiences, and to identify patient factors that might reduce SDM experiences for patients compared to the experiences of their therapists. METHODS: This cross-sectional study included 992 patients that had appointments with 267 therapists at Sørlandet Hospital, Division of Mental Health during a 1-week period. Both patients and therapists completed the CollaboRATE questionnaire, which was used to rate SDM experiences. Patients reported demographic and treatment-related information. Therapists provided clinical information. RESULTS: The analysis included 953 patient-therapist responder pairs that completed the CollaboRATE questionnaire. The mean SDM score was 80.7 (SD 20.8) among patients, and 86.6 (SD 12.1) among therapists. Females and patients that did not use medication for mental health disorders reported higher SDM scores than males and patients that used psychiatric medications (83.3 vs. 77.7; p < 0.001 and 82.6 vs. 79.8; p = 0.03, respectively). Patients with diagnoses involving psychotic symptoms reported lower SDM scores than all the other patients (66.8 vs. 82.3; p < 0.001). The probability that a patient would report lower SDM scores than their therapist was highest among patients that received involuntary treatment (OR 3.2, p = 0.02), patients with treatment durations longer than 2.2 years (OR 1.9, p = 0.001), and patients that required day care or in-patient care (OR 3.2, p = 0.01 and OR 3.2, p < 0.001, respectively). CONCLUSION: We showed that both therapists and patients reported good SDM experiences in decisional situations, which indicated that SDM was implemented well. However, the SDM scores reported by in-patients and patients with prolonged or involuntary treatments were significantly lower than scores reported by their therapists. Our findings suggested that it remains a struggle in mental health care to establish a common understanding between patients and therapists in decisional processes regarding treatments for some patient groups.

15.
Adm Policy Ment Health ; 47(6): 911-919, 2020 11.
Artículo en Inglés | MEDLINE | ID: mdl-32030595

RESUMEN

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.


Asunto(s)
Antipsicóticos , Antipsicóticos/uso terapéutico , Recolección de Datos , Humanos , Administración del Tratamiento Farmacológico , Psicometría , Reproducibilidad de los Resultados
16.
Medicine (Baltimore) ; 99(1): e18635, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-31895824

RESUMEN

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.


Asunto(s)
Trastornos Mentales/tratamiento farmacológico , Servicios de Salud Mental , Psicotrópicos/uso terapéutico , Adulto , Estudios Transversales , Femenino , Humanos , Masculino , Trastornos Mentales/psicología , Persona de Mediana Edad , Reproducibilidad de los Resultados , Encuestas y Cuestionarios , Adulto Joven
17.
J Pain Res ; 12: 2875-2889, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31686904

RESUMEN

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.

18.
J Eval Clin Pract ; 25(6): 1041-1049, 2019 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-31508872

RESUMEN

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.


Asunto(s)
Actitud del Personal de Salud , Toma de Decisiones Conjunta , Servicios de Salud Mental , Relaciones Médico-Paciente/ética , Estudios Transversales , Femenino , Humanos , Masculino , Servicios de Salud Mental/ética , Servicios de Salud Mental/normas , Persona de Mediana Edad , Evaluación de Necesidades , Noruega , Psiquiatría , Psicología , Procesos Psicoterapéuticos , Trabajadores Sociales
19.
Eur Addict Res ; 25(6): 303-309, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31340204

RESUMEN

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.


Asunto(s)
Naltrexona/uso terapéutico , Trastornos Relacionados con Opioides/tratamiento farmacológico , Aceptación de la Atención de Salud/estadística & datos numéricos , Adulto , Preparaciones de Acción Retardada/uso terapéutico , Femenino , Humanos , Masculino , Antagonistas de Narcóticos/uso terapéutico , Adulto Joven
20.
Am J Addict ; 28(2): 77-85, 2019 02.
Artículo en Inglés | MEDLINE | ID: mdl-30701613

RESUMEN

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).


Asunto(s)
Combinación Buprenorfina y Naloxona , Dolor Crónico/diagnóstico , Naltrexona , Adulto , Combinación Buprenorfina y Naloxona/administración & dosificación , Combinación Buprenorfina y Naloxona/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Naltrexona/administración & dosificación , Naltrexona/efectos adversos , Antagonistas de Narcóticos/uso terapéutico , Noruega , Tratamiento de Sustitución de Opiáceos/métodos , Trastornos Relacionados con Opioides/tratamiento farmacológico , Dimensión del Dolor
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