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 Farouk; Elrasheed, Abuelgasim; Ali, Ahmed Yousif; Shawky, Mansour; Hasan, Nael; Gawad, Tarek; Adem, Abdu; Marsden, John

doi:10.1155/2019/2491063

Cited by 10 publications

(11 citation statements)

References 51 publications

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“…Adults with OUD voluntarily seeking treatment at the NRC in Abu Dhabi-UAE were screened for eligibility at admission to a 4-week inpatient care programme (Elarabi et al, 2019). At intake, a full social history including family environment was gathered.…”

Section: Methodsmentioning

confidence: 99%

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The impact of family engagement in opioid assisted treatment: Results from a randomised controlled trial

Ghafri

Hasan

Elarabi

et al. 2020

Int J Soc Psychiatry

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Background: Family interventions in substance use disorders (SUD) treatment is limited despite the evidence for benefits. Providing family interventions is hampered by patient resistance, social stigma, logistics and factors related to the capacity of the treatment programmes. Aims: The purpose of the study was to examine the association between family engagement in treatment, and opioid use defined by percentage negative opioid screen and rate retention in treatment defined by completion of study period. Methods: Data from a 16-week outpatient randomised controlled trial (RCT) of 141 adults with opioid use disorder (OUD) receiving Opioid Assisted Treatment (OAT) using buprenorphine/naloxone film (BUP/NX-F) was, used to examine the association between family engagement in and opioid use and rate of retention in treatment. Multiple logistic regression was, applied to examine the independent prediction of family engagement on opioid use and rate retention in treatment. Results: Family engagement was significantly associated with retention in treatment (Spearman’s rho 0.25, p < 0.01) and was subsequently found to increase the likelihood of retention in treatment by approximately 3-fold (adjusted odds ratio (OR) 2.95, 95% CI 1.31–6.65). Conclusion: Family engagement in treatment is an independent predictor of retention in treatment but not opioid use in adults receiving OAT. It is, recommended that SUD treatment programmes integrate family related interventions in mainstream treatment. Delivering a personalised multicomponent family programme using digitised virtual communications that has been increasingly utilised during the Covid-19 pandemic is highly suggested.

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Section: Methodsmentioning

confidence: 99%

“…In this paper, we used data from the Suboxone Treatment and Recovery Trial (STAR-T) to examine the impact of family engagement in treatment on opioid use and rate of retention in treatment (Elarabi et al, 2019). We further suggest opportunities for developing and delivering family related interventions.…”

Section: Introductionmentioning

confidence: 99%

The impact of family engagement in opioid assisted treatment: Results from a randomised controlled trial

Ghafri

Hasan

Elarabi

et al. 2020

Int J Soc Psychiatry

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“…The NRC's Institutional Review Board approved the protocol (NRC/2/2014). The study was retrospectively registered with the ISRCTN registry (number ISRCTN416 45 723) and the study protocol was published [16]. In this article, methods and findings are reported by Consolidated Standards of Reporting Trials (CONSORT) [17].…”

Section: Designmentioning

confidence: 99%

Effectiveness of incentivised adherence and abstinence monitoring in buprenorphine maintenance: a pragmatic, randomised controlled trial

et al. 2021

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Background and Aim Buprenorphine (BUP) maintenance treatment for opioid use disorder (OUD) begins with supervised daily dosing. We estimated the clinical effectiveness of a novel incentivised medication adherence and abstinence monitoring protocol in BUP maintenance to enable contingent access to increasing take-home medication supplies.Design Two-arm, single-centre, pragmatic, randomised controlled trial of outpatient BUP maintenance, with during-treatment follow-ups at 4 weeks, 8 weeks, 12 weeks and 16 weeks. Setting Inpatient and outpatient addictions treatment centre in the United Arab Emirates. Participants Adults with OUD, voluntarily seeking treatment. Interventions The experimental condition was 16 weeks BUP maintenance with incentivised adherence and abstinence monitoring (I-AAM) giving contingent access to 7-day, then 14-day, then 21-day and 28-day medication supply. The control, treatment-as-usual (TAU) was 16 weeks BUP maintenance, with contingent access to 7-day then 14-day supply.Measurements The primary outcome was number of negative urine drug screens (UDS) for opioids, with non-attendance or otherwise missed UDS, imputed as positive for opioids. The secondary outcome was retention in treatment (continuous enrolment to the 16-week endpoint). Findings Of 182 patients screened, 171 were enrolled and 141 were randomly assigned to I-AAM (70 [49.6%]) and to TAU (71 [50.4%]. Follow-up rates at 4 weeks, 8 weeks, 12 weeks and 16 weeks were 91.4%, 85.7%, 71.0%, 60.0% respectively in I-AAM and 84.5%, 83.1%, 69.0%, 56.3% in TAU. By intention-to-treat, the absolute difference in percentage negative UDS for opioids was 76.7% (SD = 25.0%) in I-AAM versus 63.5% (SD = 34.7%) in TAU (mean difference = 13.3%; 95% CI = 3.2%-23.3%; Cohen's d = 0.44; 95% CI = 0.10-0.87). In I-AAM, 40 participants (57.1%) were retained versus 33 (46.4%) in TAU (odds ratio = 1.54; 95% CI = 0.79-2.98). Conclusions Buprenorphine maintenance with incentivised therapeutic drug monitoring to enable contingent access to increasing take-home medication supplies increased abstinence from opioids compared with buprenorphine maintenance treatment-as-usual, but it did not appear to increase treatment retention.

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“…The aim of this article was to contribute to the integration of TDM in the treatment of OUD by conducting a feasibility evaluation of TDM to monitor adherence with BUP as part of the Suboxone Treatment and Recovery Trial (STAR-T), a randomized controlled open-label trial of the sublingual film formulation of BUP/ NX (BUP/NX-F) at a specialist addiction treatment clinic in the United Arab Emirates (ISRCTN41645723) [14].…”

Section: Therapeutic Drug Monitoring In Buprenorphine/naloxone Treatmmentioning

confidence: 99%

Therapeutic Drug Monitoring in Buprenorphine/Naloxone Treatment for Opioid Use Disorder: Clinical Feasibility and Optimizing Assay Precision

Elarabi

Hasan²,

Marsden

et al. 2020

Pharmacopsychiatry

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Introduction Compliance with sublingual buprenorphine/naloxone (SL-BUP/NX) is associated with higher abstinence from illicit opioid use. Therapeutic drug monitoring (TDM) has been recommended for adherence monitoring of buprenorphine (BUP) maintenance treatment for opioid use disorder (OUD), but to date there have been no reported clinical applications. In this TDM feasibility study, we investigated BUP assay precision in 15 adults with OUD who had been stabilized on buprenorphine/naloxone. Methods Using solid phase extraction, BUP recovery was contrasted at 100 mMol and 1 Molar of acetic acid wash solution. Precision was determined by applying the condition generating highest recovery using 0.2 ng/mL and 10 ng/mL standards. Four blood samples were drawn to examine the BUP peak and trough plasma concentrations, and BUP elimination rate was estimated. BUP recovery was examined again in a random sample and contrasted with the concentration predicted applying first-order kinetics. Results Higher BUP recovery was achieved with 1 Molar wash (94.3%; p=0.05). Precision ranged from 15–20%. The estimated limit of detection (LoD) and limit of quantitation (LoQ) were 0.02 and 0.069 ng/mL, respectively. BUP peak and trough concentrations were successfully examined, and BUP trough concentrations were replicated confirming steady state. BUP concentrations were predicted at a variance of −7.20% to 1.54 %. Conclusions TDM for BUP maintenance treatment of OUD is feasible, and simple adjustment of the assay conditions enhances BUP recovery.

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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

Cited by 10 publications

References 51 publications

The impact of family engagement in opioid assisted treatment: Results from a randomised controlled trial

The impact of family engagement in opioid assisted treatment: Results from a randomised controlled trial

Effectiveness of incentivised adherence and abstinence monitoring in buprenorphine maintenance: a pragmatic, randomised controlled trial

Therapeutic Drug Monitoring in Buprenorphine/Naloxone Treatment for Opioid Use Disorder: Clinical Feasibility and Optimizing Assay Precision

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