Abstract
Background:
Opioid agonist treatment (OAT) is the mainstay for opioid use disorder (OUD). Long-acting injectable buprenorphine may address limitations of daily medications by reducing treatment burden and improving engagement. This study assessed retention and patient-reported outcomes with Buvidal® in France.
Methods:
This multicenter, observational, retrospective study analyzed medical records of adults diagnosed with OUD who received ≥1 Buvidal® injection between July 2021 and August 2023. The primary endpoint was retention at 6 months. Key secondary endpoints included changes in opioid consumption, perceived improvement in OUD using the Patient Global Impression of Change (PGIC) scale, distancing from OUD, reduction in craving, and satisfaction with Buvidal® treatment.
Results:
Among 101 participants (mean age 43.9 years; 72.3% male; 98.0% switched to Buvidal® from previous OAT), 74 (73.3%) were retained on Buvidal® at 6 months. Of those using non-prescribed or misused opioids at baseline, decreased consumption of non-prescribed or misused opioids during treatment with Buvidal® was reported by 80.0% (16/20) of retained participants and 66.7% (8/12) of non-retained participants. A significantly higher proportion of retained than non-retained participants reported improvement in OUD on PGIC (85.1% [63/74] vs 40.7% [11/27]; P < .001), increased distancing from OUD (90.5% [67/74] vs 70.4% [19/27]; P = .02), and reduced craving (91.9% [68/74] vs 66.7% [18/27]; P < .001). Satisfaction with Buvidal® was high overall (89.1% [90/101]), with 98.6% (73/74) of retained participants satisfied compared with 63.0% (17/27) of non-retained participants (P < .001). Among retained participants, 91.9% (68/74) expressed willingness to continue Buvidal® treatment beyond 6 months.
Conclusions:
Nearly three-quarters of participants initiating Buvidal® were retained in treatment at 6 months. Patient-reported outcomes indicated high satisfaction, perceived improvement in OUD, and reductions in opioid consumption and craving, even among individuals largely stabilized on OAT at baseline. These findings suggest that Buvidal® may support sustained engagement and meaningful improvements in patient experience under real-world conditions.
Highlights
Nearly three-quarters of people in France who initiated Buvidal® for opioid use disorder (OUD) were retained in treatment at 6 months.
High proportions of study participants were satisfied with treatment and perceived positive changes in OUD.
Perceived benefits of Buvidal® may be greater among individuals receiving treatment for longer versus shorter periods of time.
Introduction
Opioid use disorder (OUD) is a chronic, relapsing disease with profound impacts, including deterioration in mental and overall health, interpersonal relationships, and quality of life (QoL). 1 Globally, OUD has been estimated to affect over 16 million people, and at least 120 000 deaths/year may be attributed to opioid use. 1 In France, the estimated prevalence of high-risk opioid use was estimated as 4.4 to 7.4 per 1000 individuals, a relatively high rate for Europe. 2 The economic burden of OUD is substantial, and it is increasingly recognized as a major public health challenge.3,4
Drugs used as opioid agonist treatment (OAT) interact with μ-opioid receptors (MORs) in a controlled manner and have the potential to reduce craving for opioids and prevent withdrawal symptoms while minimizing the risks of complications such as overdose (respiratory depression and death).5,6 The 2 main drugs used as OAT are methadone and buprenorphine. Methadone is a full MOR agonist that requires careful management due to its action on the central respiratory system. 5 Buprenorphine is a partial MOR agonist and has a low risk of respiratory depression.5,7 Oral, sublingual, or buccal formulations are typically prescribed; these are taken daily and require regular medical visits, 5 which can be considered a constraint or mental burden.8-10 The administration method can lead to daily medications being diverted and misused. 11
Long-acting injectable buprenorphine (LAIB) has proven successful in addressing some of the limitations of daily buprenorphine or methadone.12-14 LAIB is at least as effective as daily buprenorphine, and similarly well tolerated.12-15 Treatment with weekly or monthly LAIB has been associated with improvements in QoL and high levels of patient satisfaction,14,16,17 with reduced treatment burden providing the freedom to engage with activities such as education, employment, or spending time with family.18,19 Currently, 2 injectable forms of buprenorphine are available in Europe: Buvidal® (Camurus; Brixadi® in the United States [Braeburn, Inc, Plymouth Meeting, PA, USA]), which offers both a weekly and a monthly formulation and is approved throughout the continent, and Subutex® prolonged release solution for injection (known outside Europe as Sublocade®), which is a monthly formulation. 20
The efficacy and safety profile of Buvidal® has been demonstrated in 2 Phase 3 studies, 1 Phase 3b study, and 1 Phase 4 study, with no difference compared with sublingual buprenorphine alone or combined with naloxone and most treatment-emergent adverse events being mild or moderate in intensity.13,16,21,22 Buvidal® has been widely adopted in countries such as Australia, Finland, and Scotland, although its use has been more limited in other countries; in France, for example, despite a widespread and well-organized supply, access is very limited due to insufficient national funding with ~600 people receiving at least 1 injection of Buvidal®, representing ~0.3% of nationwide OAT use.9,23,24 In this context, it is important to understand which people with OUD would benefit the most from LAIB, such as Buvidal®, and would be the most likely to retain in treatment. A multicenter, observational, retrospective study among people with OUD in France was conducted to determine: (1) the rate of retention, and the factors associated with retention to Buvidal® at 6 months after treatment initiation; (2) participant satisfaction with Buvidal® treatment, and perceived change in OUD, and consumption of opioids, other drugs/substances, and misused medicines; and (3) change in health and socioeconomic factors during treatment with Buvidal®.
Methods
Design
OPALE 2 was a multicenter, observational, retrospective study using individual data collected from the medical records of people with an initial Buvidal® injection between July 2021 and August 2023. The study was conducted across 13 different national addiction treatment centers in France (Supplementary Appendix, page 1). Detailed methods have been described previously. 10
Participants
The inclusion criteria were: age ≥18 years; treatment with at least 1 Buvidal® injection; and medical follow-up for at least 6 months, whether still treated or not, to enable assessment of retention. Individuals lost to follow-up (i.e., no new information after treatment) before month 6 were considered to have stopped Buvidal® treatment. Participants from OPALE 1, a retrospective, single-center study of early Buvidal® patients in France, were ineligible. 25
Participant identification for Buvidal® initiation was verified using standardized queries of center databases (medical, pharmacy, and hospital records), with all procedures performed by participating centers.
All candidates for inclusion were notified by face-to-face discussion or postal mail of the intention to anonymously extract and use their medical data in the study and given the option to refuse participation in the study by return mail or email. Non-response was considered agreement as per French regulations for retrospective studies. There were no refusals to participate. According to French regulatory requirements, ethics committee approval of the study was not required due to the retrospective, non-interventional methodology.
Endpoints
The primary endpoint was the retention rate of patients on Buvidal® at month 6. The time window of 5 to 6 months was considered for a patient to still be treated with Buvidal® at 6 months. Patients who had temporarily stopped treatment and then resumed treatment again were considered as still being treated at month 6. Discontinuation of Buvidal® was considered definitive when associated with initiation of another OAT, or when the period without Buvidal® treatment exceeded 3 months.
Secondary endpoints included the following patient-reported outcomes: perceived improvement in OUD assessed using the Patient Global Impression of Change (PGIC) scale, distancing from OUD (defined as patient-reported progress toward recovery; e.g., reduced behaviors associated with OUD), reduced craving, treatment satisfaction, willingness to continue treatment, change in consumption of opioids, other drugs/substances, and misused medicines, and changes in health and socioeconomic factors (unscheduled hospitalization or emergency room [ER] visits related to OUD, problems with the justice system, changes in work, relationships, and leisure activities). Data were extracted from medical records using structured fields in a standardized case report form; see Supplementary Appendix, pages 2 to 12 for details.
Statistics
The main objective of this observational retrospective study was essentially descriptive, and no formal sample size calculation or hypothesis-driven testing was performed. Continuous variables are expressed as mean and standard deviation, whereas discrete variables are expressed as number and percentage. Bivariate comparisons explored the associations between baseline characteristics and the dependent variable. The relationship between discrete baseline characteristics and retention at month 6 was explored using Fisher’s exact test, with retention at month 6 as the dependent variable.
As secondary objectives, exploratory analyses were also undertaken to assess the primary and secondary endpoints in 4 different participant subgroups: (1) participants with 1 or more psychiatric comorbidity; (2) participants who were co-consuming, defined as 2 or more illicit substances, with each participant only counted once (in this subgroup, misused opioid medications were included, but legal substances [e.g., alcohol, tobacco] and prescribed substances when used as directed [e.g., benzodiazepines, gabapentinoids] were excluded); (3) participants who were unemployed (not including participants who were retired or missing employment data); and (4) participants in unstable housing or homeless. These participant subgroups were chosen as these populations are perceived to be at risk of poor treatment outcomes in OUD26-29; evaluating outcomes in these subgroups may allow for a better understanding of the effectiveness of LAIB in more clinically complex patients who may face greater barriers to retention and recovery. Exploratory logistic regression assessed predictors of retention and the relationship between last Buvidal® dose and 6-month retention was explored; see Supplementary Appendix, page 13 for analysis methods.
Results
Participants’ Characteristics and Treatment
In total, 101 individuals were included in the study (Table 1). Seventy-three (72.3%) were male, the mean age was 43.9 years, 90/100 (90.0%; data missing for 1 participant) had at least 1 medical comorbidity (all types), and 83/100 (83.0%) had at least 1 psychiatric comorbidity. Buvidal® was initiated after switching from previous OAT in 99/101 (98.0%) participants; previous OAT was buprenorphine in 92/99 (92.9%) participants and methadone in 7/99 (7.1%) participants. Further details of the participants’ baseline characteristics were published previously. 10
Description of Sociodemographic Characteristics, Comorbidities, Concurrent Medications, Substance Use, and Previous OAT Among Individuals Diagnosed With OUD Initiated on Buvidal® in France.
Abbreviations: AAH, allocation aux adultes handicapés; COPD, chronic obstructive pulmonary disease; HBV, hepatitis B virus; HCV, hepatitis C virus; HIV, human immunodeficiency virus; IQR, interquartile range; OAT, opioid agonist treatment; OUD, opioid use disorder; RSA, revenu de solidarité active; SD, standard deviation.
Data are n (%) unless stated. Adapted from Deschenau et al. 10
Allowance for disabled adults, which guarantees a minimum income to people with chronic and fixed disabilities. b That is, active solidarity income, which provides a minimum level of income for people without resources, which varies according to the composition of their household. c That is, post-baccalauréat.
The median duration of follow-up (time between initiation of Buvidal® and data collection) was 13.6 months (range 5.2-24.4 months). At treatment initiation, 64 participants (63.4%) received Buvidal® weekly (dose range 8-32 mg) and the remaining 37 (36.6%) received monthly doses ranging between 64 and 160 mg. Five (5.0%) participants had a weekly only schedule (all discontinued before the first month) and 59 (58.4%) participants changed from weekly to monthly dosing during the study. All individuals retained in treatment at 6 months were receiving monthly doses of Buvidal® 64 to 160 mg.
Across the entire observation period, the median duration of treatment with Buvidal® was 8.4 months (interquartile range [IQR]: 5.0-12.1 months). Among non-retained participants, the median duration of treatment was 1.1 months (IQR: 0.5-3.8 months).
Treatment Retention
Six months after the initiation of treatment, 74 participants (73.3% of the study population, including 2 individuals censored at 5.3 and 5.6 months, respectively) were retained on Buvidal® (primary endpoint). Most non-retained participants discontinued treatment during the first 2 months (Figure 1a), with similar findings observed across participant subgroups (Figure 1b-e). Among the 27 (26.7%) non-retained individuals, the most common reasons for discontinuation were participant decision (n = 8; 29.6%), lack of efficacy (n = 4; 14.8%), and undesirable effect and lost from follow-up (both n = 3; 11.1%); for 4 participants, the reason for discontinuation was not specified. A different OAT was started after stopping Buvidal® in 55.6% (15/27) of non-retained participants (Table 2).
Six-month retention of Buvidal® treatment in (a) the overall study population, and by subgroup according to: (b) co-consumers; (c) at least 1 psychiatric comorbidity; (d) employment status; and (e) housing status.
Changes in Consumption of Non-Prescribed and Misused Opioids, Perceived Improvement in OUD and Craving, and Subsequent OAT Initiation Following Buvidal® Discontinuation.
Abbreviations: OAT, opioid agonist treatment; OUD, opioid use disorder; PGIC, Patient Global Impression of Change.
Fisher’s exact test (non-parametric test) for the comparison of retained versus non-retained participants at 6 months. b Combination of the following categories: “better, and a clear improvement that has made a real and appreciable difference” and “moderately better, and a slight but perceptible change.” c Combination of the following categories: “a little better, but the change made no real difference,” “a little better, but no significant change,” and “almost the same, almost no change.” d Distancing from OUD was defined as patient-reported progress toward recovery (e.g., reduced behaviors associated with OUD).
P < .05.
Among all participants, the treatment retention rates at 1 and 3 months were 87.1% (88/101) and 81.2% (82/101), respectively. Retention rates at 6 months ranged between 60.0% and 88.2% across the different subgroups of participants (Supplementary Figure 1 and Supplementary Table 1). There was no correlation observed between the last Buvidal® dose and retention at 6 months (Supplementary Table 2 and Supplementary Figure 2). Tobacco consumption at baseline was the only variable in the multivariate regression that retained a P < .05 (Supplementary Appendix, page 14, Supplementary Figure 3, and Supplementary Tables 3 and 4).
Changes in Consumption of Opioids, Other Drugs, Substances, and Misused Medications During Buvidal® Treatment
Of the 74 retained participants, 20 (27.0%) were consuming non-prescribed or misused opioids at treatment initiation; 16/20 (80.0%) reported a decrease in consumption after 6 months of Buvidal® treatment (Table 2).
Twelve out of the 27 non-retained participants (44.4%) were using non-prescribed or misused opioids at baseline, and 8/12 (66.7%) reported decreased consumption after starting Buvidal®, despite the short duration of treatment.
Higher proportions of retained versus non-retained participants reported decreases in the consumption of illicit drugs other than cannabis or heroin, including cocaine, crack cocaine, and 3,4-methylenedioxymethamphetamine/ecstasy or other new synthetic drugs (15/29 [51.7%] vs 4/15 [26.7%]), prescribed benzodiazepines and related substances (13/37 [35.1%] vs 3/16 [18.8%]), and alcohol (19/38 [50.0%] vs 4/13 [30.8%]; Table 3). Similar proportions of retained and non-retained participants reported a decrease in overconsumption or misuse of OAT (9/12 [75.0%] vs 4/5 [80.0%]).
Changes in Consumption of Other Drugs/Substances and Misused Medicines.
Abbreviations: OAT, opioid agonist treatment; MDMA, 3,4-methylenedioxymethamphetamine.
Other than cannabis or heroin; consumers defined as participants using one of the following drugs: cocaine, crack cocaine, MDMA, or other new synthetic drugs. b Consumers defined as participants using one of the following drugs: prescribed benzodiazepines and related substances; users of unprescribed substances were not included.
Changes in the consumption of opioids and other drugs, by subgroup, are reported in Supplementary Table 5.
Changes in Perceptions During Buvidal® Treatment
A significantly higher proportion of retained (63/74 [85.1%]) vs non-retained (11/27 [40.7%]; P < .001) participants reported a major or moderate change in OUD (much better, better, or moderately better) on the PGIC scale (Table 2). Of the 16 participants who provided details of a positive change in OUD, the most common reasons were better management of cravings (6/16 [37.5%]); overall improvement in QoL (4/16 [25.0%]); and reduced consumption of OATs, drugs, and misused medicines (3/16 [18.8%]). For 60/74 (81.1%) retained and 25/27 (92.6%) non-retained participants, the direction of the change (positive vs negative) in OUD on the PGIC was not specified, but none of the participants reported a negative change (Table 2). PGIC results by subgroup are shown in Supplementary Table 6.
A significantly higher proportion of retained versus non-retained participants reported increased distancing from OUD (67/74 [90.5%] vs 19/27 [70.4%]; P = .02) and reduced craving (68/74 [91.9%] vs 18/27 [66.7%]; P < .001; Table 2).
Unscheduled Hospitalizations and Interactions With the Justice System During Buvidal® Treatment
As shown in Table 4, the proportion of retained participants requiring hospitalization or an ER visit related to OUD was markedly lower during the 6-month Buvidal® treatment period compared with the 12 months before treatment (4/74 [5.4%] vs 17/74 [23.0%]). A reduction in the frequency of hospitalization or ER admission was also seen in non-retained participants (1/27 [3.7%] during treatment vs 5/27 [18.5%] in the prior 12 months), with no difference between retained and non-retained individuals. Similar results were reported across subgroups, with a numerical reduction in participants requiring hospitalization or ER visits during the 6-month treatment period compared with the 12 months before Buvidal® initiation (Supplementary Table 7).
Unscheduled Hospitalization and ER Visits Related to OUD During Buvidal® Treatment and the Preceding 12 Months, According to Buvidal® Treatment Status at 6 Months.
Abbreviations: ER, emergency room; OUD, opioid use disorder.
Fisher’s exact test (non-parametric test) for the comparison of retained versus non-retained participants at 6 months. b Problems with the justice system defined as problems with the law, committed offences, or time spent in police custody.
In total, 89/101 (88.1%) study participants reported no problems with the justice system during treatment with Buvidal®, with similar results between retained and non-retained participants (rates of 63/74 [85.1%] and 26/27 [96.3%] in the 2 groups, respectively; P = .4); data on justice system interactions before Buvidal® treatment are not available (Table 4 and Supplementary Table 7).
Changes in Lifestyle and Work During Buvidal® Treatment
Significantly higher proportions of retained participants compared with non-retained participants reported changes in relationships (51/74 [68.9%] vs 7/27 [25.9%]; P < .001) and leisure activities (47/74 [63.5%] vs 6/27 [22.2%]; P < .001; Table 5). With respect to changes in relationships, 17/51 (33.3%) retained participants noted a positive change in family, friends, and professional relationships, compared with 1/7 (14.3%) non-retained participants. Negative changes in relationships were noted by 2/51 (3.9%) retained participants and 0/7 (0%) non-retained participants. Positive changes in leisure activities were reported by 19/47 (40.4%) retained participants and 1/6 (16.7%) non-retained participants. None of the participants reported negative changes in leisure activities.
Changes During Buvidal® Treatment: at Work, in Relationships, and in Leisure Activities.
Abbreviations: AAH, allocation aux adultes handicapésc; RSA, revenu de solidarité actived.
Fisher’s exact test (non-parametric test) for the comparison of retained versus non-retained participants at 6 months. b Population excluding AAH/RSA, jobseeker, unemployed, and retired. c Allowance for disabled adults, which guarantees a minimum income to people with chronic and fixed disabilities. d That is, active solidarity income, which provides a minimum level of income for people without resources, which varies according to the composition of their household.
P < .05.
A numerically higher proportion of retained versus non-retained participants reported changes at work (22/74 [29.7%] vs 4/27 [14.8%]); the difference was not significant. Changes at work were positive for 13/22 (59.1%) retained participants and 2/4 (50.0%) non-retained participants. None of the participants reported negative changes at work. The direction of the change at work was not specified by 9/22 (40.9%) and 2/4 (50.0%) retained and non-retained participants, respectively.
Percentages of participants reporting changes in work, relationships, and leisure activities by subgroup are shown in Supplementary Table 8; changes at work were significantly affected by employment status, but no other statistically significant difference between subgroups was observed.
Participant Satisfaction With Buvidal® Treatment
Overall, 90/101 (89.1%) participants were satisfied with Buvidal® treatment (Table 6), with 47/90 (52.2%) grading their satisfaction as “strong,” 33/90 (36.7%) as “somewhat,” 8/90 (8.9%) as “a little,” and 2/90 (2.2%) as “very little.” A significantly higher proportion of retained participants were satisfied with Buvidal® treatment compared with non-retained participants (73/74 [98.6%] vs 17/27 [63.0%]; P < .001). Among all participants expressing satisfaction with Buvidal® treatment, overall improvement in QoL was the main positive satisfaction criterion (reported by 11/23 individuals [47.8%]).
Satisfaction and Willingness to Continue With Buvidal® Treatment
Abbreviations: LAIB, long-acting injectable buprenorphine; OAT, opioid agonist treatment; SL, sublingual.
Fisher’s exact test (non-parametric test) for the comparison of retained versus non-retained participants at 6 months.
P < .05.
The vast majority of retained participants still receiving Buvidal® at 6 months (68/74 [91.9%]) expressed willingness to continue treatment. In addition, 6/27 (22.2%) non-retained individuals showed willingness to resume treatment.
Across subgroups, the majority of participants reported that they were satisfied with Buvidal® treatment, though variations between subgroups in satisfaction and willingness to continue Buvidal® did not reach statistical significance (Supplementary Table 10).
Discussion
OPALE 2 showed high Buvidal® retention among participants with OUD from 13 French addiction centers. Retained participants were heterogeneous in terms of sociodemographic and clinical factors including comorbidities, co-consumption, professional status, and housing stability, supporting Buvidal® use across diverse OUD populations. 10
The 3-month retention rate (81%) in OPALE 2 exceeded OPALE 1 (71%), 25 and the 6-month rate (73%) was comparable to other real-world and clinical studies. For example, a UK pilot reported 80% retention at 6 months, 30 and Swedish implementation data showed 82% at 6 months, 67% at 1 year, and overall OAT continuation of 89%. 31 In Australia, Daglish et al predicted 50% retention at 1 year for the first LAIB episode, rising to 61% with re-engagement, while Farrell et al observed 47% retention at 96 weeks.28,32 In the United States, Stein et al found 48% discontinued after 3 monthly injections, 33 and Deng et al reported lower retention for patients switching from sublingual to injectable buprenorphine versus those remaining on sublingual (median 269 vs 389 days), with higher early dropout risk among early switchers. 34 These findings underscore variability in retention across settings but suggest that LAIB can support sustained engagement in diverse healthcare contexts.
The 6-month retention rate of 73% in OPALE 2 was higher than in some real-world and clinical studies, particularly U.S. cohorts. Differences may reflect a more stable population in OPALE 2 (most participants had ~10 years on buprenorphine or methadone and a low proportion of retained participants with use of non-prescribed or misused opioids at baseline [27%]), structured care in specialized centers, and fewer systemic barriers in France compared with U.S. insurance-based models. These results emphasize that LAIB retention depends on patient characteristics, transition timing, and healthcare context, underscoring the need for individualized planning and supportive care.
LAIB may improve real-world retention versus daily buprenorphine, 17 though robust evidence is lacking. Potential benefits include reduced treatment burden and related improvements (e.g., less illicit drug use, reduced craving, improved relationships), similar to gains seen with long-acting antipsychotics.35-37 In OPALE 2, most dropouts occurred early; those retained for 2 months were generally still on treatment at 6 months. Non-retained participants had higher baseline use of non-prescribed and misused opioids versus retained participants and only half transitioned to subsequent OAT, suggesting greater clinical complexity. Australian 96-week follow-up data underscore patient characteristics in retention: of 100 participants, 47 remained (median retention 90 weeks); heroin use before baseline lowered retention odds (OR = 0.19; P = .012), while older age at first opioid use (OR = 1.08; P = .009) and longer OAT duration (OR = 1.12; P = .001) increased retention. 28 No correlation was found between final dose and retention in OPALE 2, supportive of individualized dosing. Patients often value choice of weekly or monthly LAIB, which eases engagement versus daily OAT.35,38 LAIB dosing is titrated for optimal effect based on withdrawal and craving, negating adjustments for misuse or diversion. Beyond pharmacology, education, stigma reduction, improved access, and psychosocial support remain key to enhancing initiation and retention.17-20,23,24
OPALE 2 also provides real-world evidence on patient-reported outcomes with Buvidal®. PGIC scores showed meaningful improvement, with most retained participants rating their overall OUD as much better, better, or moderately better. Up to 80% of participants reduced consumption of non-prescribed or misused opioids, notable as nearly all switched from another OAT. Use of other substances also declined, consistent with reports that LAIB may reduce non-opioid drug use, though findings are mixed.14,39 Many participants reported distancing from OUD, reduced craving, and high satisfaction with Buvidal® treatment, even among non-retained individuals, supporting observed retention. Satisfaction likely reflects fewer restrictions versus daily dosing 17 and individualized regimens, though clinical need remains paramount. 40 Five participants reported negative changes: 3 due to injection-related pain; 2 still expressed overall satisfaction.
Changes in health and socioeconomic factors should be interpreted cautiously. Fewer unscheduled hospitalizations and ER visits occurred during treatment versus pre-treatment, but unequal timeframes (12 vs 6 months) limit comparability. These data provide context and align with U.S. Sublocade® findings showing reduced inpatient care (46% to 16%) and ER visits (29% to 18%) over 6 months. 41 Similarly, Swedish data reported a 50% reduction in days of inpatient care after switching to LAIB, greatest among those retained at 12 months. 31 In OPALE 2, justice system involvement was low (12% retained; 4% non-retained), though 6 months was too short to capture longer-term judicial outcomes. Reported changes in relationships, leisure, and work were largely unspecified and lacked pre-treatment data, limiting interpretation and the ability to assess change over time. Other potential benefits of LAIB include reduced treatment burden and stigma, less time in care, and lower risk of diversion and accidental pediatric exposure,13,16,21,39,42-44 ensured by administration by healthcare professionals in specialized centers. 20
Study limitations include its observational, retrospective design and possible center-level differences in data collection and assessment. Other limitations were limited quantitative data (e.g., extent of opioid use reduction, criminality pre-treatment), absence of a control group, small sample sizes for some details (e.g., positive or negative changes), lack of QoL data, and limited statistical power, warranting cautious interpretation of findings. Safety and tolerability data were also lacking. PGIC was used to assess perceived improvement but is not validated for addiction research; future studies should confirm its psychometric properties in OUD populations. Buvidal® was administered within medical, social, and psychological care per label, 45 and participants may have received additional interventions (e.g., counseling or psychosocial support), which were not systematically recorded and may have influenced outcomes, though such support may also have been part of prior treatment.
Strengths include the real-world setting, a relatively large sample representing about one-sixth of France’s treated population, and data on multiple outcomes. Although conducted in French centers, findings are likely applicable internationally.
Conclusion
In this multicenter, retrospective study, nearly three-quarters of participants initiating Buvidal® were retained at 6 months. Patient-reported outcomes showed high satisfaction, perceived improvement in OUD, and reduced opioid consumption and craving, even among a population largely stabilized on OAT at baseline. Changes in relationships, leisure activities, and work should be interpreted cautiously given the descriptive nature of the data and high proportion of unspecified responses. Overall, Buvidal® appears to reduce treatment burden and supports engagement, but further research is needed to confirm broader health and socioeconomic impacts.
Supplemental Material
sj-pdf-1-saj-10.1177_29767342261433342 – Supplemental material for Retention and Other Efficacy Outcomes With Long-Acting Injectable Buprenorphine (Buvidal®) in France: A National Retrospective Cross-Sectional Study (OPALE 2)
Supplemental material, sj-pdf-1-saj-10.1177_29767342261433342 for Retention and Other Efficacy Outcomes With Long-Acting Injectable Buprenorphine (Buvidal®) in France: A National Retrospective Cross-Sectional Study (OPALE 2) by Alice Deschenau, Pascal Melin, Julien Azuar, Benjamin Touchon, Isabelle Vinel-Jacquet, Benoit Trojak, Lisa Blecha, Julien Cabé, Margaux Kosim, Geoffroy Dupeyron, Jean-Pierre Daulouède, Georges Brousse, Mathieu Chappuy and Benjamin Rolland in Substance Use & Addiction Journal
Footnotes
Acknowledgements
The authors thank all the centers in which the study was conducted, as well as the KAPPA Santé team who handled the processes of concept and design of the study, data collection, and data analyses. Medical writing support was provided by Terri Penfold, BSc, and Ceilidh McConnachie, MSc, of Callisto, OPEN Health Communications (London, UK), and funded by Camurus, in accordance with Good Publication Practice guidelines (
). Camurus was given the opportunity to review the manuscript for medical and scientific accuracy, as well as intellectual property considerations.
Ethical Considerations
According to French regulatory requirements, ethics committee approval of the study was not required due to the retrospective, non-interventional methodology.
Consent to Participate
All candidates for inclusion were notified of the intention to anonymously extract and use their medical data in the study and given the option to refuse participation in the study; there were no refusals to participate.
Consent for Publication
All authors consent to the publication of this manuscript in Substance Use & Addiction Journal.
Author Contributions
All named authors were involved in the conception and design, acquisition and interpretation of data, provision of study materials or participants, drafting and critical review of the paper for important intellectual content, and final approval of this original research article. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
Funding
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was funded by Camurus.
Declaration of Conflicting Interests
The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: A.D.: received fees from Camurus for consulting and speaking engagements. P.M.: board member for JAM. J.A.: received fees for lectures and consultancy from Camurus, Ethypharm, and Elivie. B.To.: employee of Camurus, France. I.V.-J.: received fees from Camurus. B.Tr.: received fees for lectures and consultancy from Camurus and Ethypharm. L.B.: received honoraria for consulting from Camurus. J.C.: received fees from Camurus for consulting and speaking engagements. M.K.: employee of Camurus, France. G.D.: no conflicts to disclose. J.-P.D.: participation on Camurus board. G.B.: received fees for lectures and consultancy from Camurus, Ethypharm, Indivior, and Recordati. M.C.: received fees for lectures and consultancy from Camurus. B.R.: received fees for lectures and consultancy from Camurus, Ethypharm, Indivior, and Recordati.
Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.
References
Supplementary Material
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