Adaptation of a standard extended-release naltrexone (XR-NTX) protocol for rural re-entering offenders with OUD.
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ABSTRACT: Background
Despite a growing body of empirical support for the effectiveness of extended-release naltrexone (XR-NTX) to reduce opioid relapse among people with opioid use disorder (OUD) transitioning from a correctional facility to the community, continuity of care following release remains challenging. This paper describes a research-based adaptation of a state's standard of care XR-NTX protocol using the ADAPT-ITT framework for delivery in a non-traditional, non-treatment, community criminal justice setting (P&P office), as well as the expansion of services by a local Federally Qualified Health Center (FQHC) provider who would, for the first time, be going to the jail and P&P office to provide XR-NTX and related treatment.Method
The present study focuses on the first seven phases (Assessment through Training) of the ADAPT-ITT framework in the adaptation of the Department of Corrections (DOC) protocol in preparation for a pilot trial for induction in a rural jail and during the transition to a rural community. Expert clinical review and focus groups with key stakeholders in criminal justice supervision and the local providers in the FQHC informed the needed adaptations to the existing XR-NTX protocol for initiation at the jail and ongoing administrations in the community.Results
Findings from stakeholder focus groups, study team review, topical expert review, and a theater test suggested that there were critical adaptations needed in both content and context at the patient and clinic level.Conclusion
Health and justice officials should consider the need to tailor and adapt evidence-based approaches for real-world locations that high-risk, justice-involved individuals visit in order to reduce barriers and increase access to critically needed treatment for OUD.
SUBMITTER: Staton M
PROVIDER: S-EPMC7864137 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundExtended release naltrexone (XR-NTX) injected intramuscularly monthly has been shown to reduce relapse in persons with opioid use disorder. Baseline factors, including patients' demographics, comorbidities and lifestyle, may help identify patients who will benefit most or least from XR-NTX treatment.MethodsPotential moderators of XR-NTX's effect were examined in the largest North American randomized open-label effectiveness trial of XR-NTX. Relapse status (Yes/No) at 6-month follow-up was regressed on treatment group (XR-NTX, N=153; or Treatment-as-Usual [TAU], N=155), baseline covariates, and their two-way interaction to identify moderator effects. Baseline covariates included age, gender, summary scores for depression, suicidal thoughts, drug abuse risk, substance use, medical, psychiatric and employment status, socialization, legal and family/social issues, history of abuse and quality of life measures.ResultsAlcohol use to intoxication in the 30days before randomization was a significant moderator: during the treatment phase, those who reported being recently intoxicated before randomization to XR-NTX relapsed to opioids at a rate (56%) similar to TAU (58%), while those without alcohol intoxication in the prior 30days had a lower rate of opioid relapse (41% vs. 65%, respectively, P<0.04).ConclusionsXR-NTX appeared to work equally well across subgroups with diverse demographic, addiction, mental health and environmental characteristics, with the possible exception of working better among those without recent alcohol intoxication. These findings should be reassuring to practitioners increasingly using XR-NTX as medical addiction therapy in diverse and often vulnerable populations.
| S-EPMC5565721 | biostudies-literature
Project description:BACKGROUND:Opioid use disorder is common in prison populations, and prison release is a high-risk time for relapse and overdose. Initiation of extended release injectable naltrexone (XR-NTX)) prior to prison release might decrease relapse among opioid-dependent persons. OBJECTIVE:This pilot study examined the feasibility and acceptability of XR-NTX injection prior to prison release among adult inmates with opioid use disorder, followed by six months of community XR-NTX treatment. It sought to determine effects on treatment retention and abstinence compared to post-release XR-NTX initiation. METHODS:Recruitment for the study took place at the RIDOC's Adult Correctional Institute (ACI). Volunteers with a history of opioid dependence and a release date scheduled within 1-2months were self-referred in response to recruitment fliers. Consented volunteers were randomized to XR-NTX treatment prior to release followed by 5 monthly treatments in the community (pre-release) or six XR-NTX treatments in the community (post-release). RESULTS:Of 26 volunteers consented, 15 were randomized (9 pre-release, 6 post-release). The pre-release group generally had better treatment retention: 100% received the first NTX injection (vs. 67% post-release), 78% received more than one injection (vs. 17%) and 22% received all 6 injections (vs. 0%). The pre-release group also had greater abstinence, with a higher proportion of self-reported opioid free days in the first month after release (83% vs. 46%, fewer positive urine drug tests in the 6months after release (22% vs. 33%), and more days of opioid receptor blockade during the first two weeks after release, a high risk time for overdose death. CONCLUSIONS:Initiation of XR-NTX injection prior to release from prison might be an effective approach to reduce relapse to opioids, but these findings require confirmation in a larger trial.
| S-EPMC5648627 | biostudies-literature
Project description:ObjectiveExplore the efficacy of extended-release injectable naltrexone (XR-NTX) for preventing relapse to amphetamine use.MethodClinical trial of 100 amphetamine-dependent, treatment-seeking patients who were randomized to 6 monthly 380 mg doses of XR-NTX or matching placebo before entering intensive outpatient after varying lengths of inpatient treatment in Reykjavik, Iceland. Weekly urine drug tests, retention, and standardized instruments assessed efficacy.ResultsOf 169 approached, 100 were randomized. Although amphetamine dependence was the main reason for seeking treatment, three-quarters or more of participants had 1 or more other substance dependencies. Of 51 randomized to XR-NTX, 20 received 4 or more injections; of 49 assigned to placebo, 26 received 4 or more injections. Of the planned 2400 weekly urine drug tests, 1247 were collected (52%); 4% of these were positive for amphetamine, 8% for benzodiazepine, 7% for marijuana, 1% for cocaine, and 1% for opioid. XR-NTX had no effect on amphetamine-positive tests, retention, or other outcomes. Those providing half or more of their tests attended more weeks of treatment than those providing less than half of their tests (m = 10.76 vs 3.31; t (92) = 5.91, P < 0.0001), and 92 participants provided at least 1 test.ConclusionsAdding XR-NTX to the usual combination of inpatient and intensive outpatient treatment did not reduce amphetamine use. The low prevalence of substance use among collected urine samples, and the association between collected samples and weeks in treatment, was consistent with other studies showing that staying in treatment is associated with better outcomes.
| S-EPMC5449233 | biostudies-literature
Project description:BackgroundExtended-release naltrexone, a sustained-release monthly injectable formulation of the full mu-opioid receptor antagonist, is effective for the prevention of relapse to opioid dependence. Data supporting its effectiveness in U.S. criminal justice populations are limited.MethodsIn this five-site, open-label, randomized trial, we compared a 24-week course of extended-release naltrexone (Vivitrol) with usual treatment, consisting of brief counseling and referrals for community treatment programs, for the prevention of opioid relapse among adult criminal justice offenders (i.e., persons involved in the U.S. criminal justice system) who had a history of opioid dependence and a preference for opioid-free rather than opioid maintenance treatments and who were abstinent from opioids at the time of randomization. The primary outcome was the time to an opioid-relapse event, which was defined as 10 or more days of opioid use in a 28-day period as assessed by self-report or by testing of urine samples obtained every 2 weeks; a positive or missing sample was computed as 5 days of opioid use. Post-treatment follow-up occurred at weeks 27, 52, and 78.ResultsA total of 153 participants were assigned to extended-release naltrexone and 155 to usual treatment. During the 24-week treatment phase, participants assigned to extended-release naltrexone had a longer median time to relapse than did those assigned to usual treatment (10.5 vs. 5.0 weeks, P<0.001; hazard ratio, 0.49; 95% confidence interval [CI], 0.36 to 0.68), a lower rate of relapse (43% vs. 64% of participants, P<0.001; odds ratio, 0.43; 95% CI, 0.28 to 0.65), and a higher rate of opioid-negative urine samples (74% vs. 56%, P<0.001; odds ratio, 2.30; 95% CI, 1.48 to 3.54). At week 78 (approximately 1 year after the end of the treatment phase), rates of opioid-negative urine samples were equal (46% in each group, P=0.91). The rates of other prespecified secondary outcome measures--self-reported cocaine, alcohol, and intravenous drug use, unsafe sex, and reincarceration--were not significantly lower with extended-release naltrexone than with usual treatment. Over the total 78 weeks observed, there were no overdose events in the extended-release naltrexone group and seven in the usual-treatment group (P=0.02).ConclusionsIn this trial involving criminal justice offenders, extended-release naltrexone was associated with a rate of opioid relapse that was lower than that with usual treatment. Opioid-use prevention effects waned after treatment discontinuation. (Funded by the National Institute on Drug Abuse; ClinicalTrials.gov number, NCT00781898.).
| S-EPMC5454800 | biostudies-literature
Project description:BackgroundCurrent guidelines for opioid dependence recommend daily maintenance of physical dependence with methadone or buprenorphine, and discourage abstinence due to the high risk of relapse and overdose. Extended-release formulations of the opioid antagonist naltrexone (XR-NTX) block heroin and other opioid agonists competitively for around 4 weeks per administration. XR-NTX thus enables opioid users to experience abstinence from opioid agonists with greatly reduced risk of overdose compared to medication-free abstinence. While XR-NTX has shown promise compared to placebo and daily naltrexone tablets, there is limited information on long-term safety and its performance compared to daily maintenance treatment.Methods/designIn this five-hospital RCT with long-term follow-up, we aim to recruit n = 180 patients in treatment for opioid dependence and allocate them in an open, randomized manner (1:1) to receive either 4-week XR-NTX or daily buprenorphine-naloxone (BP-NLX) for the duration of 12 weeks. Allocation is open-label due to the risk of overdose during attempts to self-unmask allocation using heroin. Urine drug tests are scheduled every week with follow-up visits & assessment every 4 weeks. Primary outcomes are abstinence from illicit opioids in urine drug tests and self-report, as well as retention in treatment. Secondary outcomes include other substance use, injecting behavior, drug craving, mental health, quality of life, treatment satisfaction, abstinence motivation, opioid agonist effect rating, insomnia, and pain. Observation is continued for another 36 weeks in order to assess longer-term safety, adherence and effectiveness. The study is an investigator-initiated trial, funded by public grants and approved by an Independent Ethical Committee (the Regional Ethical Committee for Research South-East B # 2011/1320) and the Norwegian Medicines Agency.DiscussionDespite minor implementation problems, the protocol appears sufficiently robust to generate results of high interest to patients, clinicians and policy makers.Trial registrationClinicaltrials.gov # NCT01717963 , first registered: Oct 28, 2012. Protocol version # 3C, June 12th 2012.
| S-EPMC4848871 | biostudies-literature
Project description:IntroductionSaxagliptin added to metformin extended release (XR) and uptitrated metformin XR were evaluated for their impact on daily glucose measurements and their tolerability in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin monotherapy.MethodsPatients aged 18-78 years on metformin 850-1,500 mg with glycated hemoglobin (HbA1c) 7.5-11.5% at screening were eligible for this double-blind, active-controlled study. Patients were stabilized on metformin XR 1,500 mg before randomization. Patients with HbA1c 7-11% and fasting plasma glucose (FPG) ≥126 mg/dL after a 4- 8-week lead-in period were randomly assigned to saxagliptin 5 mg + metformin XR 1,500 mg or metformin XR 500 mg + metformin XR 1,500 mg (uptitrated metformin XR). The primary end point was change from baseline to week 4 in 24-h mean weighted glucose (MWG). Secondary end points were changes from baseline to week 4 in 2-h postprandial glucose (PPG) and FPG.ResultsAt week 4, the adjusted mean ± SE change from baseline in 24-h MWG was -19.0 ± 5.7 mg/dL (95% CI -30.3 to -7.6) for saxagliptin + metformin XR and -8.2 ± 6.0 mg/dL (95% CI -20.0 to 3.7) for uptitrated metformin XR. Mean changes from baseline in 2-h PPG and FPG were numerically greater with saxagliptin + metformin XR versus uptitrated metformin XR. The incidence of adverse events was lower with saxagliptin + metformin XR (17.4%) versus uptitrated metformin XR (31.9%) mainly due to differences in gastrointestinal adverse event incidence (2.2% vs 10.6%, respectively). There were no reports of confirmed hypoglycemia in either group.ConclusionIn this 4-week study in patients with T2DM inadequately controlled with metformin monotherapy, saxagliptin added to metformin XR demonstrated a trend for improvement in measures of daily glycemic control, with fewer gastrointestinal adverse events, compared with uptitrated metformin.
| S-EPMC3889315 | biostudies-literature
Project description:BackgroundExtended-release (XR) naltrexone can prevent relapse to opioid use disorder following detoxification. However, one of the barriers to initiating XR-naltrexone is the recommendation for a 7-10-day period of abstinence from opioids prior to the first dose.ObjectivesThe current study evaluated the feasibility of an XR-naltrexone induction protocol that can be implemented over 1 week in the outpatient clinic.MethodsParticipants (N = 44) were seen in the clinic daily. On Day 1, after abstaining from opioids for at least 12 h, they received buprenorphine 6-8 mg. Adjunctive medications (clonidine, clonazepam, zolpidem, trazodone, and prochlorperazine) were dispensed on Days 2-5, while ascending oral doses of naltrexone were given on Days 3-5 starting with 1 mg dose. An injection of XR-naltrexone was given on Day 5, 1 h after receiving and tolerating naltrexone 24 mg.ResultsOf the 44 participants (38 males), 35 (80%) were heroin users and 9 (20%) used prescription opioids. A total of 26 participants (59%) completed the induction and received their first injection of XR-naltrexone. XR-naltrexone was initiated in 54% (19/35) of heroin users and 78% (7/9) of prescription opioid users.ConclusionThe results support the feasibility of a week-long outpatient induction onto XR-naltrexone with ascending doses of naltrexone and standing doses of adjunctive medications. By circumventing the need for a protracted period of abstinence and mitigating the severity of withdrawal symptoms experienced during naltrexone titration, this strategy has the potential to increase patient acceptability and access to relapse prevention treatment with XR-naltrexone.
| S-EPMC7260104 | biostudies-literature
Project description:BackgroundExtended-release naltrexone (XR-NTX) is an injectable monthly sustained-release mu opioid receptor antagonist, which blocks the typical effects of heroin and other opioid agonists. Use of XR-NTX among opioid dependent persons leaving jails and prisons is increasing despite scant high-quality evidence regarding XR-NTX's effectiveness at re-entry.MethodsThis 24-week, open-label randomized controlled trial examines the effectiveness of XR-NTX as opioid relapse prevention at release from jail (N=85) compared to enhanced treatment as usual (ETAU, N=85). A third, non-randomized, quasi-experimental naturalistic arm of participants who have newly initiated a jail-to-community methadone treatment program (MTP, N=85) allows for comparisons to a methadone standard-of-care.ResultsWe describe the rationale, design, and primary and secondary outcomes of the study. The primary outcome is an opioid relapse event; the primary contrast is a time-to-relapse comparison of XR-NTX and ETAU over a 24-week treatment phase. Secondary outcomes are rates of: (a) post-release opioid treatment participation, (b) opioid, alcohol, and cocaine use, (c) injection drug use and HIV sexual risk behaviors, (d) overdose (fatal and non-fatal) and all-cause mortality, and, (e) re-incarceration.ConclusionsXR-NTX is a potentially important, effective treatment and relapse prevention option for a large US population of persons with opioid use disorders leaving jails. This study will estimate XR-NTX's effectiveness relative to existing standards of care, including counseling-only treatment-as-usual and methadone maintenance.
| S-EPMC5455014 | biostudies-literature
Project description:Naltrexone is a ?-opioid receptor antagonist that blocks opioid effects. Craving, depression, anxiety, and anhedonia are common among opioid dependent individuals and concerns have been raised that naltrexone increases them due to blocking endogenous opioids. Here, we present data that address these concerns.Assess the relationship between affective responses and naltrexone treatment.Opioid dependent patients (N = 306) were enrolled in a three cell (102ss/cell) randomized, double blind, double dummy, placebo-controlled 6-month trial comparing extended release implantable naltrexone with oral naltrexone and placebo (oral and implant). Monthly assessments of affective responses used a Visual Analog Scale for opioid craving, the Beck Depression Inventory, Spielberger Anxiety Test, and the Ferguson and Chapman Anhedonia Scales. Between-group outcomes were analyzed using mixed model analysis of variance (Mixed ANOVA) and repeated measures and the Tukey test for those who remained and treatment and did not relapse, and between the last measure before dropout with the same measure for those remaining in treatment.Depression, anxiety, and anhedonia were elevated at baseline but reduced to normal within the first 1-2 months for patients who remained in treatment and did not relapse. Other than a slight increase in two anxiety measures at week two, there were no significant between-group differences prior to treatment dropout.These data do not support concerns that naltrexone treatment of opioid dependence increases craving, depression, anxiety or anhedonia.
| S-EPMC5156574 | biostudies-literature
Project description:AIMS:To review systematically the published literature on extended-release naltrexone (XR-NTX, Vivitrol® ), marketed as a once-per-month injection product to treat opioid use disorder. We addressed the following questions: (1) how successful is induction on XR-NTX; (2) what are adherence rates to XR-NTX; and (3) does XR-NTX decrease opioid use? Factors associated with these outcomes as well as overdose rates were examined. METHODS:We searched PubMed and used Google Scholar for forward citation searches of peer-reviewed papers from January 2006 to June 2017. Studies that included individuals seeking treatment for opioid use disorder who were offered XR-NTX were included. RESULTS:We identified and included 34 studies. Pooled estimates showed that XR-NTX induction success was lower in studies that included individuals that required opioid detoxification [62.6%, 95% confidence interval (CI) = 54.5-70.0%] compared with studies that included individuals already detoxified from opioids (85.0%, 95% CI = 78.0-90.1%); 44.2% (95% CI = 33.1-55.9%) of individuals took all scheduled injections of XR-NTX, which were usually six or fewer. Adherence was higher in prospective investigational studies (i.e. studies conducted in a research context according to a study protocol) compared to retrospective studies of medical records taken from routine care (6-month rates: 46.7%, 95% CI = 34.5-59.2% versus 10.5%, 95% CI = 4.6-22.4%, respectively). Compared with referral to treatment, XR-NTX reduced opioid use in adults under criminal justice supervision and when administered to inmates before release. XR-NTX reduced opioid use compared with placebo in Russian adults, but this effect was confounded by differential retention between study groups. XR-NTX showed similar efficacy to buprenorphine when randomization occurred after detoxification, but was inferior to buprenorphine when randomization occurred prior to detoxification. CONCLUSIONS:Many individuals intending to start extended-release naltrexone (XR-NTX) do not and most who do start XR-NTX discontinue treatment prematurely, two factors that limit its clinical utility significantly. XR-NTX appears to decrease opioid use but there are few experimental demonstrations of this effect.
| S-EPMC5993595 | biostudies-literature