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

Solli, Kristin Klemmetsby; Kunøe, Nikolaj; Latif, Zill-E-Huma; Sharma-Haase, Kamni; Opheim, Arild; Krajči, Peter; Gaulen, Zhanna; Benth, Jūratė Šaltytė; Tanum, Lars

doi:10.1159/000501931

Cited by 8 publications

(10 citation statements)

References 36 publications

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“…The mean age was 36 years, and 82% were men. Patients’ characteristics were representative of the full patient group enrolled into the parent study [ 12 , 26 , 38 , 40 , 41 ].…”

Section: Resultsmentioning

confidence: 99%

“…The patients’ characteristics corresponded well with the total sample of the parent study [ 12 , 26 ]. When entering the parent study, a limited number of participants were already in recovery in OMT and not using illicit substances, while a majority reported ongoing illicit substance use and serious addiction‐related problems [ 38 ]. While opioid‐dependent individuals already in recovery in OMT may need XR‐NTX in a shorter transition phase to obtain medication‐free abstinence over time, those who have an ongoing opioid addiction and addiction‐related problems are likely to need longer‐term treatment.…”

Section: Discussionmentioning

confidence: 99%

“…This prospective 2‐year cohort study was a prolonged follow‐up to a previous 3‐month randomized clinical trial comparing XR‐NTX with BP‐NLX [ 26 ] and a subsequent 9‐month follow‐up study of XR‐NTX [ 12 , 38 , 39 , 40 , 41 ]. At the conclusion of the 9‐month follow‐up study, participants were offered continued treatment with XR‐NTX up to a period of 104 weeks.…”

Section: Methodsmentioning

confidence: 99%

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Adapting treatment length to opioid‐dependent individuals’ needs and preferences: a 2‐year follow‐up to a 1‐year study of extended‐release naltrexone

et al. 2021

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Background and aims Extended‐release naltrexone (XR‐NTX) is an under‐used 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 and participants Five urban, outpatient addiction clinics in Norway, comprising opioid‐dependent adults aged 18–60 years (n = 50) already participating in the parent study. Intervention XR‐NTX administered as intramuscular 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% confidence interval (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 9–12 months of treatment. Participants reported high treatment satisfaction and 70% showed no relapse to opioids during the treatment period.

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“…The mean age was 36 years, and 82% were men. Patients’ characteristics were representative of the full patient group enrolled into the parent study [ 12 , 26 , 38 , 40 , 41 ].…”

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Adapting treatment length to opioid‐dependent individuals’ needs and preferences: a 2‐year follow‐up to a 1‐year study of extended‐release naltrexone

et al. 2021

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“…The participants in the current study can be characterized as a selfselected sample, by pursuing a novel and "unknown" treatment, despite the comparatively unrestricted availability of OMT and other treatment approaches in Norway. This may involve more dissatisfaction with OMT, a stronger drive for abstinence, and showing a higher interest in treatment alternatives to OMT (Sharma Haase et al, 2016;Solli et al, 2019). Self-selection might have been a further issue in the current study, where those who chose to participate might have been those who were reconciled with the result of their "failed" XR-NTX treatment.…”

Section: Methodological Considerationsmentioning

confidence: 92%

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

Brenna

Marciuch

Birkeland

et al. 2022

Journal of Substance Abuse Treatment

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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.

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“…There has been a growing interest in XR-NTX treatment in some countries [20,21] and a strong increase in the number of treatment programs offering such treatment in the US in recent years [22]. A study comparing XR-NTX with buprenorphine-naloxone (BP-NLX) in Norway attracted >40% of people who were not previously in OMT and who reported a more severe heroin use than those who were already in treatment [23]. The results showed, however, that this group had higher retention rates than OMT patients, suggesting that there are opioid-dependent goal-oriented people looking for alternative therapies.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2021

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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.

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

Abstract: The authors wish to thank all the participants who shared their stories with us. We also thank the study sites and staff members that helped recruit participants.

Cited by 8 publications

References 36 publications

Adapting treatment length to opioid‐dependent individuals’ needs and preferences: a 2‐year follow‐up to a 1‐year study of extended‐release naltrexone

Adapting treatment length to opioid‐dependent individuals’ needs and preferences: a 2‐year follow‐up to a 1‐year study of extended‐release naltrexone

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

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

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