Dataset Information

Suboxone Treatment and Recovery Trial (STAR-T): Study Protocol for a Randomised Controlled Trial of Opioid Medication Assisted Treatment with Adjunctive Medication Management Using Therapeutic Drug Monitoring and Contingency Management.

ABSTRACT:

Introduction

Opioid assisted treatment (OAT) with buprenorphine (BUP) is front-line medical maintenance intervention for illicit and prescription opioid use disorder (OUD). In many clinics, opioid medication is dispensed for several days for self-administration. This provides flexibility to the patient but may compromise the effectiveness of OAT because of nonadherence or medication diversion. OAT can be delivered as an entirely supervised intervention, but many patients discontinue treatment under this arrangement and dispensing costs may be prohibitive. An alternative is to enable patients to receive take-home doses contingent on OAT adherence guided by a medication management framework using Therapeutic Drug Monitoring (TDM) alongside negative urine drug screens (UDS) to provide evidence of abstinence. TDM is recommended to monitor adherence with BUP but it has not been applied in OAT programs and evaluation research to date.

Methods

The Suboxone Treatment and Recovery Trial (STAR-T) is a single site, 16-week, parallel-group, randomised controlled trial. The aim of the study is to determine the effectiveness of a medication management framework including TDM and UDS to enable patients enrolled on outpatient OAT (with buprenorphine/naloxone [sublingual film formulation; BUP/NX-F; Suboxone™]) to receive stepped take-home doses. Following stabilisation during inpatient care, adult participants with illicit or prescription OUD were allocated (1:1) to receive (1) BUP/NX-F plus medication management for take-home doses based on TDM, UDS, and contingency management protocol (the experimental group) or (2) BUP/NX-F plus UDS only (treatment-as-usual, the control group). The primary outcome is the mean percentage of negative UDS over 16 weeks. The secondary outcome is treatment retention defined as completion of 16 weeks of OAT without interruption. There will be an exploratory analysis of the association between participant characteristics, clinical data, and outcomes.

Conclusions

Providing BUP/NX-F take-home doses contingent on adherence and opioid abstinence may enable OAT to be delivered flexibly and effectively.

Trial registration

ISRCTN41645723 is retrospectively registered on 15/11/2015.

SUBMITTER: Elarabi H

PROVIDER: S-EPMC6425325 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Suboxone Treatment and Recovery Trial (STAR-T): Study Protocol for a Randomised Controlled Trial of Opioid Medication Assisted Treatment with Adjunctive Medication Management Using Therapeutic Drug Monitoring and Contingency Management.

Elarabi Hesham H Elrasheed Abuelgasim A Ali Ahmed A Shawky Mansour M Hasan Nael N Gawad Tarek A TA Adem Abdu A Marsden John J

Journal of addiction 20190305

<h4>Introduction</h4>Opioid assisted treatment (OAT) with buprenorphine (BUP) is front-line medical maintenance intervention for illicit and prescription opioid use disorder (OUD). In many clinics, opioid medication is dispensed for several days for self-administration. This provides flexibility to the patient but may compromise the effectiveness of OAT because of nonadherence or medication diversion. OAT can be delivered as an entirely supervised intervention, but many patients discontinue trea ...[more]

PMID: 30956839

Similar Datasets

Project description:ImportanceMedication treatment for opioid use disorder (MOUD) is efficacious, but comorbid stimulant use and other behavioral health problems often undermine efficacy.ObjectiveTo examine the association of contingency management, a behavioral intervention wherein patients receive material incentives contingent on objectively verified behavior change, with end-of-treatment outcomes for these comorbid behavioral problems.Data sourcesA systematic search of PubMed, Cochrane CENTRAL, Web of Science, and reference sections of articles from inception through May 5, 2020. The following search terms were used: vouchers OR contingency management OR financial incentives.Study selectionProspective experimental studies of monetary-based contingency management among participants receiving MOUD.Data extraction and synthesisFollowing Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline, 3 independent investigators extracted data from included studies for a random-effects meta-analysis.Main outcomes and measuresPrimary outcome was the association of contingency management at end-of-treatment assessments with 6 clinical problems: stimulant use, polysubstance use, illicit opioid use, cigarette smoking, therapy attendance, and medication adherence. Random-effects meta-analysis models were used to compute weighted mean effect size estimates (Cohen d) and corresponding 95% CIs separately for each clinical problem and collapsing across the 3 categories assessing abstinence and the 2 assessing treatment adherence outcomes.ResultsThe search identified 1443 reports of which 74 reports involving 10 444 unique adult participants met inclusion criteria for narrative review and 60 for inclusion in meta-analyses. Contingency management was associated with end-of-treatment outcomes for all 6 problems examined separately, with mean effect sizes for 4 of 6 in the medium-large range (stimulants, Cohen d = 0.70 [95% CI, 0.49-0.92]; cigarette use, Cohen d = 0.78 [95% CI, 0.43-1.14]; illicit opioid use, Cohen d = 0.58 [95% CI, 0.30-0.86]; medication adherence, Cohen d = 0.75 [95% CI, 0.30-1.21]), and 2 in the small-medium range (polysubstance use, Cohen d = 0.46 [95% CI, 0.30-0.62]; therapy attendance, d = 0.43 [95% CI, 0.22-0.65]). Collapsing across abstinence and adherence categories, contingency management was associated with medium effect sizes for abstinence (Cohen d = 0.58; 95% CI, 0.47-0.69) and treatment adherence (Cohen d = 0.62; 95% CI, 0.40-0.84) compared with controls.Conclusions and relevanceThese results provide evidence supporting the use of contingency management in addressing key clinical problems among patients receiving MOUD, including the ongoing epidemic of comorbid psychomotor stimulant misuse. Policies facilitating integration of contingency management into community MOUD services are sorely needed.

Project description:BackgroundContingency management (CM) is an evidence-based intervention for stimulant use and is highly effective in combination with medication for opioid use disorder. Yet, uptake of CM in opioid treatment programs that provide medication for opioid use disorder remains low. This paradox in which CM is one of the most effective interventions, yet one of the least available, represents one of the greatest research-to-practice gaps in the addiction health services field. Multi-level implementation strategies are needed to address barriers to CM implementation at both the provider- and organization-level. This type III hybrid effectiveness-implementation trial was funded by the National Institute on Drug Abuse to evaluate whether a multi-level implementation strategy, the Science of Service Laboratory (SSL), can effectively promote CM implementation in opioid treatment programs. Specific aims will test the effectiveness of the SSL on implementation outcomes (primary aim) and patient outcomes (secondary aim), as well as test putative mediators of implementation outcomes (exploratory aim).MethodsUtilizing a fully powered type III hybrid effectiveness-implementation trial with a stepped wedge design, we propose to randomize a cohort of 10 opioid treatment programs to receive the SSL across four steps. Each step, an additional 2-3 opioid treatment programs will receive the SSL implementation strategy, which has three core components: didactic training, performance feedback, and external facilitation. At six intervals, each of the 10 opioid treatment programs will provide de-identified electronic medical record data from all available patient charts on CM delivery and patient outcomes. Staff from each opioid treatment program will provide feedback on contextual determinants influencing implementation at three timepoints.DiscussionBetween planning of this protocol and receipt of funding, the landscape for CM in the USA changed dramatically, with multiple Departments of Health launching state-wide CM initiatives. We therefore accelerated the protocol timeline and offered some cursory training resources to all sites as a preparation activity. We also began partnering with multiple Departments of Health to evaluate their rollout of CM using the measures outlined in this protocol.Trial registrationThis study protocol is registered via ClinicalTrials.gov Identifier: NCT05702021. Date of registration: January 27, 2023.

Project description:OBJECTIVES:Contingency management (CM) is a treatment for substance misuse that involves the provision of incentives. This review examines the hypothesis that adding another formal psychotherapy, such as cognitive-behavioural therapy (CBT) or motivational enhancement therapy (MET), to CM improves substance use outcomes at both treatment end and at post-treatment follow-up compared with CM only. DATA SOURCES:Searches were performed in December 2017 and July 2019 of seven electronic bibliographic databases (MEDLINE, PsycINFO, EMBASE, Scopus, Web of Science, CINAHL, PsycEXTRA), as well as online trial registries and EThoS, and were followed by reference list screening. ELIGIBILITY CRITERIA:Included studies were randomised controlled trials of adults (18-65) who were using illicit substances, alcohol or tobacco. Studies featured an experimental arm delivering CM combined with a structured evidence-based psychotherapeutic intervention and a CM-only arm. Studies published up to July 2019 were included. DATA EXTRACTION AND SYNTHESIS:The primary outcome was biometrically verified point prevalent abstinence (PPA) at treatment end. Secondary outcomes included biometrically verified PPA at post-treatment follow-up and self-reported days of use at treatment end and post-treatment follow-up. Pooled risk ratios for PPA outcomes and standardised mean differences for days of use were calculated using random effects models. Risk of bias was assessed using the Grading of Recommendations Assessment, Development and Evaluation. RESULTS:12 studies (n=1654) were included. The primary analysis found no evidence of a synergistic effect in PPA at treatment end (relative risk (RR) 0.97, 95% CI 0.85 to 1.09; p=0.57). Sensitivity analysis of studies featuring CBT/MET also found no evidence of an effect (RR 0.92; 95% CI 0.79 to 1.08; p=0.32). None of the secondary outcomes showed any evidence of benefit. CONCLUSION:The results of the meta-analyses found no evidence that combining CM with another intervention improves the short-term or long-term effects of CM treatment.

Project description:BackgroundContingency management (CM) is one of the only behavioral interventions shown to be effective for the treatment of opioid use disorders when delivered alone and in combination with pharmacotherapy. Despite extensive empirical support, uptake of CM in community settings remains abysmally low. The current study applied user-centered design principles to gather qualitative data on familiarity with CM, current clinical practice, and preferences regarding the implementation of CM in community-based opioid treatment programs.MethodsParticipants were 21 leaders and 22 front-line counselors from 11 community-based opioid treatment programs. Semi-structured interviews were about 45 min long. Transcripts from each interview were coded by independent raters and analyzed using a reflexive team approach. Frequencies of responses were tallied, and queries were run in NVivo to identify exemplar quotes for each code.ResultsResults indicated low familiarity with CM, with less than half of the respondents defining CM correctly and over 40% of respondents declining to answer/ did not know. Abstinence was the most commonly recommended CM target, yet over 70% of respondents indicated that urine screens only occurred monthly. Attendance was also a popular recommendation, with respondents suggesting a range of possible indices including counseling, dosing, and/or case management sessions. Regarding the ideal role to administer CM prizes, program directors and supervisors were most commonly recommended, closely followed by front-line counselors. The most commonly suggested strategies to afford CM incentives included soliciting community donations and offering non-financial incentives.ConclusionsUser design principles to understand workflow constraints, target user needs, and simplify the intervention guided this qualitative investigation of CM implementation in opioid treatment programs. Findings highlighted the potential value of flexible, organization-specific definitions of CM attendance and non-financial incentives, as well as active involvement of clinical leaders and supervisors to promote buy in among staff/patients. Respondents were generally optimistic about their ability to fundraise or solicit donations to overcome cost-related barriers of CM. Implications for CM implementation strategies, including the use of targeted leadership coaching focused on sustainability, are explored.

Project description:BACKGROUND:Opioid dependence has devastating and increasingly widespread consequences and costs, and the most common outcome of treatment is early relapse. People who inject opioids are also at disproportionate risk for contracting the human immunodeficiency virus (HIV) and hepatitis C virus (HCV). This study tests an approach that has been shown to improve recovery rates: medication along with other supportive services (medication-assisted treatment, or MAT) against MAT combined with a smartphone innovation called A-CHESS (MAT?+?A-CHESS). METHODS/DESIGN:This unblinded study will randomly assign 440 patients to receive MAT?+?A-CHESS or MAT alone. Eligible patients will meet criteria for having an opioid use disorder of at least moderate severity and will be taking methadone, injectable naltrexone, or buprenorphine. Patients with A-CHESS will have smartphones for 16 months; all patients will be followed for 24 months. The primary outcome is the difference between patients in the two arms in percentage of days using illicit opioids during the 24-month intervention. Secondary outcomes are differences between patients receiving MAT?+?A-CHESS versus MAT in other substance use, quality of life, retention in treatment, health service use, and, related to HIV and HCV, screening and testing rates, medication adherence, risk behaviors, and links to care. We will also examine mediators and moderators of the effects of MAT?+?A-CHESS. We will measure variables at baseline and months 4, 8, 12, 16, 20, and 24. At each point, patients will respond to a 20- to 30-min phone survey; urine screens will be collected at baseline and up to twice a month thereafter. We will use mixed-effects to evaluate the primary and secondary outcomes, with baseline scores functioning as covariates, treatment condition as a between-subject factor, and the outcomes reflecting scores for a given assessment at the six time points. Separate analyses will be conducted for each outcome. DISCUSSION:A-CHESS has been shown to improve recovery for people with alcohol dependence. It offers an adaptive and extensive menu of services and can attend to patients nearly as constantly as addiction does. This suggests the possibility of increasing both the effectiveness of, and access to, treatment for opioid dependence. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02712034 . Registered on 14 March 2016.

Project description:Background: Opioids accounted for 75% of drug overdoses in the United States in 2020, with rural states particularly impacted by the opioid crisis. While medication assisted treatment (MAT) with Suboxone remains one of the more efficacious treatments for opioid use disorder (OUD), approximately 40% of people receiving Suboxone for outpatient MAT for OUD (MOUD) relapse within the first 6 months of treatment. We developed the smartphone app-based intervention OptiMAT as an adjunctive intervention to improve MOUD outcomes. The aims of this study are to (1) evaluate the efficacy of adjunctive OptiMAT use in reducing opioid misuse among people receiving MOUD; and (2) evaluate the role of specific OpitMAT features in reducing opioid misuse, including the use of GPS-driven just-in-time intervention. Methods: We will conduct a two-arm, single-blind, randomized controlled trial of adults receiving outpatient MOUD in the greater Little Rock AR area. Participants are English-speaking adults ages 18 or older recently enrolled in outpatient MOUD at one of our participating study clinics. Participants will be allocated via 1:1 randomized block design to (1) MOUD with adjunctive use of OptiMAT (MOUD+OptiMAT) or (2) MOUD without OptiMAT (MOUD-only). Our blinded research statistician will evaluate differences between the two groups in opioid misuse (as determined by quantitative urinalysis conducted by clinical lab staff blinded to group membership) during the 6-months following study enrolment. Secondary analyses will evaluate if OptiMAT-usage patterns within the MOUD+OptiMAT group predict opioid misuse or continued abstinence. Discussion: This study will test if adjunctive use of OptiMAT improve MOUD outcomes. Study findings could lead to expansion of OptiMAT into rural clinical settings, and the identification of OptiMAT features which best predict positive clinical outcome could lead to refinement of this and similar smartphone appbased interventions. Trial registration: ClinicalTrials.gov identifier: NCT05336188, registered March 21, 2022, https://clinicaltrials.gov/ct2/show/NCT05336188.

Project description:BackgroundOpioids accounted for 75% of drug overdoses in the USA in 2020, with rural states particularly impacted by the opioid crisis. While medication-assisted treatment (MAT) with Suboxone remains one of the more efficacious treatments for opioid use disorder (OUD), approximately 40% of people receiving Suboxone for outpatient MAT for OUD (MOUD) relapse within the first 6 months of treatment. We developed the smartphone app-based intervention OptiMAT as an adjunctive intervention to improve MOUD outcomes. The aims of this study are to (1) evaluate the efficacy of adjunctive OptiMAT use in reducing opioid misuse among people receiving MOUD and (2) evaluate the role of specific OptiMAT features in reducing opioid misuse, including the use of GPS-driven just-in-time intervention.MethodsWe will conduct a two-arm, single-blind, randomized controlled trial of adults receiving outpatient MOUD in the greater Little Rock AR area. Participants are English-speaking adults ages 18 or older recently enrolled in outpatient MOUD at one of our participating study clinics. Participants will be allocated via 1:1 randomized block design to (1) MOUD with adjunctive use of OptiMAT (MOUD+OptiMAT) or (2) MOUD without OptiMAT (MOUD-only). Our blinded research statistician will evaluate differences between the two groups in opioid misuse (as determined by quantitative urinalysis conducted by clinical lab staff blinded to group membership) during the 6-months following study enrolment. Secondary analyses will evaluate if OptiMAT-usage patterns within the MOUD+OptiMAT group predict opioid misuse or continued abstinence.DiscussionThis study will test if adjunctive use of OptiMAT improve MOUD outcomes. Study findings could lead to expansion of OptiMAT into rural clinical settings, and the identification of OptiMAT features which best predict positive clinical outcome could lead to refinement of this and similar smartphone app-based interventions.Trial registrationClinicalTrials.gov identifier: NCT05336188 , registered March 21, 2022.

Dataset Information

Suboxone Treatment and Recovery Trial (STAR-T): Study Protocol for a Randomised Controlled Trial of Opioid Medication Assisted Treatment with Adjunctive Medication Management Using Therapeutic Drug Monitoring and Contingency Management.

Introduction

Methods

Conclusions

Trial registration

Publications

Suboxone Treatment and Recovery Trial (STAR-T): Study Protocol for a Randomised Controlled Trial of Opioid Medication Assisted Treatment with Adjunctive Medication Management Using Therapeutic Drug Monitoring and Contingency Management.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets