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Methadone induction in primary care for opioid dependence: a pragmatic randomized trial (ANRS Methaville).

ABSTRACT: Methadone coverage is poor in many countries due in part to methadone induction being possible only in specialized care (SC). This multicenter pragmatic trial compared the effectiveness of methadone treatment between two induction models: primary care (PC) and SC.In this study, registered at ClinicalTrials.Gov (NCT00657397), opioid-dependent individuals not on methadone treatment for at least one month or receiving buprenorphine but needing to switch were randomly assigned to start methadone in PC (N = 155) or in SC (N = 66) in 10 sites in France. Visits were scheduled at months M0, M3, M6 and M12. The primary outcome was self-reported abstinence from street-opioids at 12 months (M12) (with an underlying 15% non-inferiority hypothesis for PC). Secondary outcomes were abstinence during follow-up, engagement in treatment (i.e. completing the induction period), retention and satisfaction with the explanations provided by the physician. Primary analysis used intention to treat (ITT). Mixed models and the log-rank test were used to assess the arm effect (PC vs. SC) on the course of abstinence and retention, respectively.In the ITT analysis (n = 155 in PC, 66 in SC), which compared the proportions of street-opioid abstinent participants, 85/155 (55%) and 22/66 (33%) of the participants were classified as street-opioid abstinent at M12 in PC and SC, respectively. This ITT analysis showed the non-inferiority of PC (21.5 [7.7; 35.3]). Engagement in treatment and satisfaction with the explanations provided by the physician were significantly higher in PC than SC. Retention in methadone and abstinence during follow-up were comparable in both arms (p = 0.47, p = 0.39, respectively).Under appropriate conditions, methadone induction in primary care is feasible and acceptable to both physicians and patients. It is as effective as induction in specialized care in reducing street-opioid use and ensuring engagement and retention in treatment for opioid dependence.Number Eudract 2008-001338-28; ClinicalTrials.gov: NCT00657397; International Standard Randomized Controlled Trial Number Register ISRCTN31125511.

SUBMITTER: Carrieri PM

PROVIDER: S-EPMC4231094 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Methadone induction in primary care for opioid dependence: a pragmatic randomized trial (ANRS Methaville).

Carrieri Patrizia Maria PM Michel Laurent L Lions Caroline C Cohen Julien J Vray Muriel M Mora Marion M Marcellin Fabienne F Spire Bruno B Morel Alain A Roux Perrine P

PloS one 20141113 11

<h4>Objective</h4>Methadone coverage is poor in many countries due in part to methadone induction being possible only in specialized care (SC). This multicenter pragmatic trial compared the effectiveness of methadone treatment between two induction models: primary care (PC) and SC.<h4>Methods</h4>In this study, registered at ClinicalTrials.Gov (NCT00657397), opioid-dependent individuals not on methadone treatment for at least one month or receiving buprenorphine but needing to switch were random ...[more]

PMID: 25393311

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Project description:In France, the rapid scale-up of buprenorphine, an opioid maintenance treatment (OMT), in primary care for drug users has led to an impressive reduction in HIV prevalence among injecting drug users (IDU) but has had no major effect on Hepatitis C incidence. To date, patients willing to start methadone can only do so in a methadone clinic (a medical centre for drug and alcohol dependence (CSAPA) or a hospital setting) and are referred to primary care physicians after dose stabilization. This study aims to assess the effectiveness of methadone in patients who initiated treatment in primary care compared with those who initiated it in a CSAPA, by measuring abstinence from street opioid use after one year of treatment.The ANRS-Methaville study is a randomized multicenter non-inferiority control trial comparing methadone induction (lasting approximately 2 weeks) in primary care and in CSAPA. The model of care chosen for methadone induction in primary care was based on study-specific pre-training of all physicians, exclusion criteria and daily supervision of methadone during the initiation phase. Between January 2009 and January 2011, 10 sites each having one CSAPA and several primary care physicians, were identified to recruit patients to be randomized into two groups, one starting methadone in primary care (n = 147), the other in CSAPA (n = 48). The primary outcome of the study is the proportion of participants abstinent from street opioids after 1 year of treatment i.e. non-inferiority of primary care model in terms of the proportion of patients not using street opioids compared with the proportion observed in those starting methadone in a CSAPA.The ANRS-Methaville study is the first in France to use an interventional trial to improve access to OMT for drug users. Once the non-inferiority results become available, the Ministry of Health and agency for the safety of health products may change the the New Drug Application (NDA) of methadone and make methadone induction by trained primary care physicians possible.The trial is registered with the French Agency of Pharmaceutical Products (AFSSAPS) under the number 2008-A0277-48, the European Union Drug Regulating Authorities Clinical Trials.Number Eudract 2008-001338-28, the ClinicalTrials.gov Identifier: NCT00657397 and the International Standard Randomised Controlled Trial Number Register ISRCTN31125511.

Project description:BackgroundMost people with opioid use disorder (OUD) never receive treatment. Medication treatment of OUD in primary care is recommended as an approach to increase access to care. The PRimary Care Opioid Use Disorders treatment (PROUD) trial tests whether implementation of a collaborative care model (Massachusetts Model) using a nurse care manager (NCM) to support medication treatment of OUD in primary care increases OUD treatment and improves outcomes. Specifically, it tests whether implementation of collaborative care, compared to usual primary care, increases the number of days of medication for OUD (implementation objective) and reduces acute health care utilization (effectiveness objective). The protocol for the PROUD trial is presented here.MethodsPROUD is a hybrid type III cluster-randomized implementation trial in six health care systems. The intervention consists of three implementation strategies: salary for a full-time NCM, training and technical assistance for the NCM, and requiring that three primary care providers have DEA waivers to prescribe buprenorphine. Within each health system, two primary care clinics are randomized: one to the intervention and one to Usual Primary Care. The sample includes all patients age 16-90 who visited the randomized primary care clinics from 3 years before to 2 years after randomization (anticipated to be > 170,000). Quantitative data are derived from existing health system administrative data, electronic medical records, and/or health insurance claims ("electronic health records," [EHRs]). Anonymous staff surveys, stakeholder debriefs, and observations from site visits, trainings and technical assistance provide qualitative data to assess barriers and facilitators to implementation. The outcome for the implementation objective (primary outcome) is a clinic-level measure of the number of patient days of medication treatment of OUD over the 2 years post-randomization. The patient-level outcome for the effectiveness objective (secondary outcome) is days of acute care utilization [e.g. urgent care, emergency department (ED) and/or hospitalizations] over 2 years post-randomization among patients with documented OUD prior to randomization.DiscussionThe PROUD trial provides information for clinical leaders and policy makers regarding potential benefits for patients and health systems of a collaborative care model for management of OUD in primary care, tested in real-world diverse primary care settings. Trial registration # NCT03407638 (February 28, 2018); CTN-0074 https://clinicaltrials.gov/ct2/show/NCT03407638?term=CTN-0074&draw=2&rank=1.

Project description:IMPORTANCE:Prescription opioid dependence is increasing and creates a significant public health burden, but primary care physicians lack evidence-based guidelines to decide between tapering doses followed by discontinuation of buprenorphine hydrochloride and naloxone hydrochloride therapy (hereinafter referred to as buprenorphine therapy) or ongoing maintenance therapy. OBJECTIVE:To determine the efficacy of buprenorphine taper vs ongoing maintenance therapy in primary care-based treatment for prescription opioid dependence. DESIGN, SETTING, AND PARTICIPANTS:We conducted a 14-week randomized clinical trial that enrolled 113 patients with prescription opioid dependence from February 17, 2009, through February 1, 2013, in a single primary care site. INTERVENTIONS:Patients were randomized to buprenorphine taper (taper condition) or ongoing buprenorphine maintenance therapy (maintenance condition). The buprenorphine taper was initiated after 6 weeks of stabilization, lasted for 3 weeks, and included medications for opioid withdrawal, after which patients were offered naltrexone treatment. The maintenance group received ongoing buprenorphine therapy. All patients received physician and nurse support and drug counseling. MAIN OUTCOMES AND MEASURES:Illicit opioid use via results of urinanalysis and patient report, treatment retention, and reinitiation of buprenorphine therapy (taper group only). RESULTS:During the trial, the mean percentage of urine samples negative for opioids was lower for patients in the taper group (35.2% [95% CI, 26.2%-44.2%]) compared with those in the maintenance group (53.2% [95% CI, 44.3%-62.0%]). Patients in the taper group reported more days per week of illicit opioid use than those in the maintenance group once they were no longer receiving buprenorphine (mean use, 1.27 [95% CI, 0.60-1.94] vs 0.47 [95% CI, 0.19-0.74] days). Patients in the taper group had fewer maximum consecutive weeks of opioid abstinence compared with those in the maintenance group (mean abstinence, 2.70 [95% CI, 1.72-3.75] vs 5.20 [95% CI, 4.16-6.20] weeks). Patients in the taper group were less likely to complete the trial (6 of 57 [11%] vs 37 of 56 [66%]; P?<?.001). Sixteen patients in the taper group reinitiated buprenorphine treatment after the taper owing to relapse. CONCLUSIONS AND RELEVANCE:Tapering is less efficacious than ongoing maintenance treatment in patients with prescription opioid dependence who receive buprenorphine therapy in primary care. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT00555425.

Project description:BackgroundChronic pain is common, disabling, and costly. Few clinical trials have examined cognitive behavioral therapy (CBT) interventions embedded in primary care settings to improve chronic pain among those receiving long-term opioid therapy.ObjectiveTo determine the effectiveness of a group-based CBT intervention for chronic pain.DesignPragmatic, cluster randomized controlled trial. (ClinicalTrials.gov: NCT02113592).SettingKaiser Permanente health care systems in Georgia, Hawaii, and the Northwest.ParticipantsAdults (aged ≥18 years) with mixed chronic pain conditions receiving long-term opioid therapy.InterventionA CBT intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team (behaviorist, nurse, physical therapist, and pharmacist) versus usual care.MeasurementsSelf-reported pain impact (primary outcome, as measured by the PEGS scale [pain intensity and interference with enjoyment of life, general activity, and sleep]) was assessed quarterly over 12 months. Pain-related disability, satisfaction with care, and opioid and benzodiazepine use based on electronic health care data were secondary outcomes.ResultsA total of 850 patients participated, representing 106 clusters of primary care providers (mean age, 60.3 years; 67.4% women); 816 (96.0%) completed follow-up assessments. Intervention patients sustained larger reductions on all self-reported outcomes from baseline to 12-month follow-up; the change in PEGS score was -0.434 point (95% CI, -0.690 to -0.178 point) for pain impact, and the change in pain-related disability was -0.060 point (CI, -0.084 to -0.035 point). At 6 months, intervention patients reported higher satisfaction with primary care (difference, 0.230 point [CI, 0.053 to 0.406 point]) and pain services (difference, 0.336 point [CI, 0.129 to 0.543 point]). Benzodiazepine use decreased more in the intervention group (absolute risk difference, -0.055 [CI, -0.099 to -0.011]), but opioid use did not differ significantly between groups.LimitationThe inclusion of only patients with insurance in large integrated health care systems limited generalizability, and the clinical effect of change in scores is unclear.ConclusionPrimary care-based CBT, using frontline clinicians, produced modest but sustained reductions in measures of pain and pain-related disability compared with usual care but did not reduce use of opioid medication.Primary funding sourceNational Institutes of Health.

Project description:BACKGROUND: Migraine is a common, disabling headache disorder that leads to lost quality of life and productivity. We investigated whether a proactive approach to patients with migraine, including an educational intervention for general practitioners, led to a decrease in headache and associated costs. METHODS: We conducted a pragmatic randomized controlled trial. Participants were randomized to one of two groups: practices receiving the intervention and control practices. Participants were prescribed two or more doses of triptan per month. General practitioners in the intervention group received training on treating migraine and invited participating patients for a consultation and evaluation of the therapy they were receiving. Physicians in the control group continued with usual care. Our primary outcome was patients' scores on the Headache Impact Test (HIT-6) at six months. We considered a reduction in score of 2.3 points to be clinically relevant. We used the Kessler Psychological Distress Scale (K10) questionnaire to determine if such distress was a possible effect modifier. We also examined the interventions' cost-effectiveness. RESULTS: We enrolled 490 patients in the trial (233 to the intervention group and 257 to the control group). Of the 233 patients in the intervention group, 192 (82.4%) attended the consultation to evaluate the treatment of their migraines. Of these patients, 43 (22.3%) started prophylaxis. The difference in change in score on the HIT-6 between the intervention and control groups was 0.81 (p = 0.07, calculated from modelling using generalized estimating equations). For patients with low levels of psychological distress (baseline score on the K10 ? 20) this change was -1.51 (p = 0.008), compared with a change of 0.16 (p = 0.494) for patients with greater psychological distress. For patients who were not using prophylaxis at baseline and had two or more migraines per month, the mean HIT-6 score improved by 1.37 points compared with controls (p = 0.04). We did not find the intervention to be cost-effective. INTERPRETATION: An educational intervention for general practitioners and a proactive approach to patients with migraine did not result in a clinically relevant improvement of symptoms. Psychological distress was an important confounder of success. (Current Controlled Trials registration no. ISRCTN72421511.).

Project description:IntroductionQuitlines are effective in helping smokers quit, but pediatrician quitline referral rates are low, and few parents who smoke use the service. This study compared enrollment of parents who smoke in the quitline using electronic referral with that using manual referral.Study designThe study was designed as a pragmatic RCT.Setting/participantsParticipants were recruited from one large, urban pediatric primary care site in Philadelphia, Pennsylvania with a high percentage of low-income families. Participants included adult parents who smoked and were present at their child's healthcare visit.InterventionPediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral ("warm handoff") involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). Control group procedures were identical to eReferral, except the quitline number was provided to the parent. Data were collected between March 2017 and February 2018 and analyzed in 2018.Main outcome measuresThe primary outcome was the proportion of parents enrolled in quitline treatment. Secondary outcomes included parent factors (e.g., demographics, nicotine dependence, and quitting motivation) associated with successful enrollment. Number of quitline contacts was also explored.ResultsDuring the study period, in the eReferral group, 10.3% (24 of 233) of parents who smoked and were interested in quitting enrolled in the quitline, whereas only 2.0% (5 of 251) of them in the control group enrolled in the quitline-a difference of 8.3% (95% CI=4.0, 12.6). Parents aged ≥50 years enrolled in the quitline more frequently. Although more parents in the eReferral group connected to the quitline, among parents who had at least one quitline contact, there was no significant difference in the mean number of quitline contacts between eReferral and control groups (mean, 2.04 vs 2.40 calls; difference, 0.36 [95% CI=0.35, 1.06]).ConclusionsSmoking parent eReferral from pediatric primary care may increase quitline enrollment and could be adopted by practices interested in increasing rates of parent treatment.Trial registrationThis study is registered at www.clinicaltrials.gov NCT02997735.

Project description:Opioid use disorder (OUD) represents a public health crisis in the United States. Medication for opioid use disorder (MOUD) with buprenorphine in primary care is a proven OUD treatment strategy. MOUD induction is when patients begin withdrawal and receive the first doses of buprenorphine. Differences between induction methods might influence short-term stabilization, long-term maintenance, and quality of life. This paper describes the protocol for a study designed to: (1) compare short-term stabilization and long-term maintenance treatment engagement in MOUD in patients receiving office, home, or telehealth induction and (2) identify clinically-relevant practice and patient characteristics associated with successful long-term treatment. The study design is a randomized, parallel group, pragmatic comparative effectiveness trial of three care models of MOUD induction in 100 primary care practices in the United States. Eligible patients are at least 16 years old, have been identified by their clinician as having opioid dependence and would benefit from MOUD. Patients will be randomized to one of three induction comparators: office, home, or telehealth induction. Primary outcomes are buprenorphine medication-taking and illicit opioid use at 30, 90, and 270 days post-induction. Secondary outcomes include quality of life and potential mediators of treatment maintenance (intentions, planning, automaticity). Potential moderators include social determinants of health, substance use history and appeal, and executive function. An intent to treat analysis will assess effects of the interventions on long-term treatment, using general/generalized linear mixed models, adjusted for covariates, for the outcomes analysis. Analysis includes practice- and patient-level random effects for hierarchical/longitudinal data. No large-scale, randomized comparative effectiveness research has compared home induction to office or telehealth MOUD induction on long-term outcomes for patients with OUD seen in primary care settings. The results of this study will offer primary care providers evidence and guidance in selecting the most beneficial induction method(s) for specific patients.

Dataset Information

Methadone induction in primary care for opioid dependence: a pragmatic randomized trial (ANRS Methaville).

Publications

Methadone induction in primary care for opioid dependence: a pragmatic randomized trial (ANRS Methaville).

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