Opportunistic Treatment of Hepatitis C Infection Among Hospitalized People Who Inject Drugs (OPPORTUNI-C): A Stepped Wedge Cluster Randomized Trial.

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.

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

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.

Chronic Pain Among Patients With an Opioid Use Disorder.

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).

Risk of Relapse Among Opioid-Dependent Patients Treated With Extended-Release Naltrexone or Buprenorphine-Naloxone: A Randomized Clinical Trial.

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).

The Antipsychotic Medication Management Fidelity Scale: Psychometric properties.

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.

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

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).

Availability of Extended-Release Naltrexone May Increase the Number of Opioid-Dependent Individuals in Treatment: Extension of a Randomized Clinical Trial.

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.

Antidepressants have Anti-inflammatory Effects that may be Relevant to Dermatology: A Systematic Review.

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.

Interest in Extended Release Naltrexone among Opioid Users.

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.

Cognitive Effects of Bifrontal Versus Right Unilateral Electroconvulsive Therapy in the Treatment of Major Depression in Elderly Patients: A Randomized, Controlled Trial.

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.

Tapering from Methadone or Buprenorphine during Pregnancy: Maternal and Neonatal Outcomes in Norway 1996-2009.

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.

Adverse childhood experiences and their association with substance use disorders in adulthood: A general population study (Young-HUNT).

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.

Personal recovery among people with opioid use disorder during treatment with extended-release naltrexone.

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.

Risk of relapse to non-opioid addictive substances among opioid dependent patients treated with an opioid receptor antagonist or a partial agonist: A randomized clinical trial.

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.

Amphetamine-induced psychosis--a separate diagnostic entity or primary psychosis triggered in the vulnerable?

Use of amphetamine and methamphetamine is widespread in the general population and common among patients with psychiatric disorders. Amphetamines may induce symptoms of psychosis very similar to those of acute schizophrenia spectrum psychosis. This has been an argument for using amphetamine-induced psychosis as a model for primary psychotic disorders. To distinguish the two types of psychosis on the basis of acute symptoms is difficult. However, acute psychosis induced by amphetamines seems to have a faster recovery and appears to resolve more completely compared to schizophrenic psychosis. The increased vulnerability for acute amphetamine induced psychosis seen among those with schizophrenia, schizotypal personality and, to a certain degree other psychiatric disorders, is also shared by non-psychiatric individuals who previously have experienced amphetamine-induced psychosis. Schizophrenia spectrum disorder and amphetamine-induced psychosis are further linked together by the finding of several susceptibility genes common to both conditions. These genes probably lower the threshold for becoming psychotic and increase the risk for a poorer clinical course of the disease.The complex relationship between amphetamine use and psychosis has received much attention but is still not adequately explored. Our paper reviews the literature in this field and proposes a stress-vulnerability model for understanding the relationship between amphetamine use and psychosis.

[Gender- and age-related differences in dosage and serum concentration of psychotropic drugs]. / Kjønns- og aldersforskjeller ved bruk av psykofarmaka.

BACKGROUND: The dose recommendations in the Norwegian Pharmaceutical Product Compendium (Felleskatalogen) are not gender-specific, despite evidence of gender-dependent differences in the metabolism of a number of drugs. The purpose of this study was to investigate the extent to which age and gender influence the prescription and serum concentration of psychotropic drugs. MATERIAL AND METHOD: The prescribed doses and serum concentrations of antidepressant, antipsychotic and antiepileptic drugs were studied in relation to age and gender in 1533 patients. RESULTS: Elderly women (≥ 65 years) were given somewhat lower doses of antidepressant drugs, but they had significantly higher serum concentrations than younger patients of either gender. Antidepressant drugs were prescribed in fairly high doses in the study population; the median number of defined daily doses was 1.5. INTERPRETATION: The study suggests that when prescribing drugs, Norwegian physicians do not take sufficient account of the effect of age and gender on the pharmacokinetics of antidepressant drugs.

Life satisfaction among individuals with opioid use disorder receiving extended-release naltrexone: A 12-week randomized controlled trial and a 36-week follow-up.

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.

Impact of Impulsivity, Hyperactivity, and Inattention on Discontinuation Rate among Opioid-Dependent Patients Treated with Extended-Release Naltrexone.

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.

'Not at all what I had expected': Discontinuing treatment with extended-release naltrexone (XR-NTX): A qualitative study.

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.

Patients' experiences of continued treatment with extended-release naltrexone: a Norwegian qualitative study.

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.