Dataset Information

Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial.

ABSTRACT:

Background

Opioids 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.

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 app-based interventions.

Trial registration

ClinicalTrials.gov identifier: NCT05336188 , registered March 21, 2022.

SUBMITTER: Thompson RG

PROVIDER: S-EPMC10071730 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Publications

Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial.

Thompson Ronald G RG Bollinger Mary M Mancino Michael J MJ Hasin Deborah D Han Xiaotong X Bush Keith A KA Kilts Clint D CD James G Andrew GA

Trials 20230404 1

<h4>Background</h4>Opioids 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 ...[more]

PMID: 37016394

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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:IntroductionIllicit opioid use has become a national crisis in Canada, with over 65 000 people seeking treatment for opioid use disorder (OUD) in Ontario and British Columbia alone. Medication-assisted treatment (MAT) is a common treatment for OUD. There is substantial variability in treatment outcomes used to evaluate effectiveness of MAT, making it difficult to establish clinically and scientifically relevant treatment effect. Furthermore, patients are often excluded from the process of determining these outcomes. The primary objective of this review is to examine outcomes currently used to measure MAT effectiveness and to identify patient-relevant outcomes to enhance effectiveness of treatment options. This review refers to patient-important outcomes as those outcomes patients consider important to or markers of treatment success.Methods and analysisMEDLINE, EMBASE, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, Web of Science, Cochrane Library, Cochrane Clinical Trials Registry, National Institutes for Health Clinical Trials Registry and WHO International Clinical Trials Registry Platform databases will be searched. We will search databases from inception to the date the search is ran. Studies of interest include those evaluating the effectiveness of MAT for patients with OUD, with or without consultation with patients regarding what they consider to be important as an indicator of treatment success. Results will be analysed using thematic analysis and qualitative analysis where possible. This will result in comprehensive synthesis of all outcomes and measures found related to OUD treatment effectiveness.Ethics and disseminationWe are collaborating with Canadian Addiction Treatment Centres which provide MAT to patients with OUD who will participate in disseminating study results. Dissemination strategies will involve sharing study results through workshops, presentations, peer-reviewed publications, study reports, community presentations and resources in primary care settings.Prospero registration numberCRD42018095553.

Project description:BACKGROUND:Social functioning (SF), the ability to engage with life and fulfill roles may be a salient "patient important outcome" in addiction treatment. It is not known if medication-assisted treatment (MAT) impacts SF in opioid use disorder (OUD). There is a growing evidence to suggest that men and women are impacted differently by OUD. This study is the largest to date to study sex differences in OUD and explore associations between MAT and SF. METHODS:Data were collected from 2736 participants with OUD, enrolled in MAT for varying lengths of time, in outpatient clinics across Ontario. SF was defined according to the Maudsley Addiction Profile's domains of (1) employment, (2) criminal activity, and (3) interpersonal conflict. Using logistic regression analysis, we examined sociodemographic and clinical factors associated with domains of SF. RESULTS:There were 1544 men (56%) and 1192 women (44%) in this study, and ages varied from 17 to 76 years for men and 18 to 69 years for women. At study entry, participants had been on MAT for a median of 2 years. Compared to men, women reported more psychological (mean MAP score 14/40, SD = 9.55, versus 11/40, SD = 8.64; p < 0.001) and physical symptoms (mean MAP score 17/40, SD = 7.70 versus 14/40, SD = 7.74; p < 0.001). More women reported unemployment(74% versus 58%; p < 0.0001) and interpersonal conflict (46% versus 35%; p < 0.0001). Men were more likely than women to report criminal activity (11%, versus 8%; p = 0.001). Psychological symptoms increased the risk of worse SF, across domains, for men and for women. Every year on MAT was associated with a 7% increase in the odds of women engaging with criminal activity (OR = 1.07, 95% CI 1.02, 1.12, p = 0.006). CONCLUSIONS:Men and women had different SF profiles and psychological symptoms scores while on MAT. The length of time on MAT increased the risk of criminal activity in women, and overall, duration of MAT was not associated with improvement in SF. This may suggest that MAT alone may not support continual improvements in SF in OUD.

Project description:ImportanceOpioid use disorder continues to be a national crisis, contributing to substantial morbidity and mortality. Medication is the only evidence-based treatment for opioid use disorder; however, improving clinical outcomes may require augmenting it with psychosocial interventions, such as contingency management (CM), specifically, smartphone app-based CM.ObjectiveTo evaluate whether augmenting medication for opioid use disorder (MOUD) with app-based CM is associated with fewer days of opioid use at the end of treatment and greater retention than treatment with MOUD only.Design, setting, and participantsThis retrospective cohort study used data from November 1, 2020, to November 30, 2023, collected from opioid treatment programs and office-based opioid treatment programs across Texas. The cohort included individuals aged 18 years or older who were uninsured or underinsured and who chose to receive MOUD only or MOUD plus CM delivered via the WEconnect smartphone app. Participants who chose to receive app-based CM received monetary incentives upon achieving their self-chosen recovery goals.ExposureOpioid use disorder.Main outcomes and measuresPrimary analyses examined differences in treatment outcomes (self-reported days of opioid use at the end of treatment and retention) between patients who chose MOUD only and those who chose MOUD plus app-based CM. Linear regression analysis was used to examine days of opioid use at the end of treatment, and Cox proportional hazards regression analysis was used to examine retention.ResultsThe analytic sample comprised 600 individuals (mean [SD] age, 38.4 [8.6] years; 342 male [57.0%]), with 300 included in each treatment group. Those who chose to receive MOUD plus app-based CM reported significantly fewer days of opioid use at the end of treatment compared with those who chose to receive MOUD only (mean [SD] duration, 8.4 [12.9] vs 12.0 [13.5] days; β = -6.10; 95% CI, -8.09 to -4.10). Retention analysis showed that patients who chose to receive MOUD plus app-based CM were significantly more likely to stay in treatment longer compared with those who chose to receive MOUD only (mean [SD] duration, 290.2 [109.4] vs 236.1 [128.1] days; β = 51.91; 95% CI, 33.86 to 69.95).Conclusions and relevanceThese findings suggest that augmenting MOUD with app-based CM may provide clinical benefits for underserved patients. Expanding the availability of app-based CM may contribute to decreasing the societal, economic, and personal burden of opioid use.

Project description:ImportanceIn the literature on opioid use disorder (OUD), opioid abstinence is used as an outcome measure for individuals receiving medication-assisted treatment (MAT), without consideration of patient-reported goals (PRGs).ObjectivesTo identify common PRGs for youths receiving MAT for OUD and assess whether these patients achieve their stated goals.Design, setting, and participantsThis prospective cohort study examined data from 152 individuals aged 16 to 25 years (noninclusive) recruited between May 22, 2018, and March 11, 2020, from 45 outpatient MAT clinics in the Pharmacogenetics of Opioid Substitution Treatment Response study. Youths receiving MAT for OUD were included and were followed up for 3 months.ExposuresMedication-assisted treatment for OUD.Main outcomes and measuresThe frequency of each PRG; the success of goal attainment, compared between those who reported specific PRGs and those who did not; and associations between reporting certain goals and achieving them.ResultsAmong the 152 youths in the study, 82 were male (53.9%), and the mean (SD) age was 22.8 (1.8) years. Ten overarching goals were identified, with the most common being to taper the dose of or stop MAT (96 [63.2%]), avoid use of recreational substances (71 [46.7%]), manage OUD symptoms (25 [16.4%]), live a normal life (14 [9.2%]), improve mental health (11 [7.2%]), and gain employment (8 [5.3%]). Overall, individuals who reported PRGs had similar odds of achieving them as those who did not for the goals of taper dose of or stop MAT (OR, 1.98; 95% CI, 0.88-4.46; P = .10), avoid recreational substances (OR, 1.34; 95% CI, 0.65-2.74; P = .43), manage OUD symptoms (β coefficient, -0.93; 95% CI, -4.24 to 2.38; P = .58), and improve mental health (β coefficient, -0.76; 95% CI, -6.31 to 4.78; P = .79). Furthermore, multivariable logistic regression showed that goals to taper the dose of or stop MAT (odds ratio, 1.90; 95% CI, 0.78-4.63; P = .16) or avoid recreational substances (odds ratio, 1.27; 95% CI, 0.60-2.67; P = .53) were not associated with achieving these respective outcomes.Conclusions and relevanceThis study suggests that youths have highly variable PRGs regarding MAT for OUD and that reporting a goal may not mean one is at higher odds of achieving it. There is a need to develop treatment plans that effectively incorporate PRGs. In addition, the finding that most youths aim to minimize or stop their MAT dose warrants the creation of a tapering protocol to guide clinicians. Because a diagnosis of OUD has substantial psychosocial implications in this population, clinicians must ensure that these dimensions of care are part of routine clinical practice.

Dataset Information

Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial.

Background

Methods

Discussion

Trial registration

Publications

Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial.

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