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

Hesham Farouk Elarabi; Mansour Shawky; Nael Mustafa; Doaa Radwan; Abuelgasim Elarasheed; Ahmed Yousif Ali; Mona Osman; Ahmed Kashmar; Helal Al Kathiri; Tarek Gawad; Ayman Kodera; Mohammed Al Jneibi; Abdu Adem; Amanda J. Lee; John Marsden

doi:10.1111/add.15394

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

Hesham Farouk Elarabi^*, Mansour Shawky, Nael Mustafa, Doaa Radwan, Abuelgasim Elarasheed, Ahmed Yousif Ali, Mona Osman, Ahmed Kashmar, Helal Al Kathiri, Tarek Gawad, Ayman Kodera, Mohammed Al Jneibi, Abdu Adem, Amanda J. Lee, John Marsden

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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Abstract

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.

Original language	English
Pages (from-to)	2398-2408
Number of pages	11
Journal	Addiction
Volume	116
Issue number	9
Early online date	6 Jan 2021
DOIs	https://doi.org/10.1111/add.15394
Publication status	Published - Sept 2021

Bibliographical note

Acknowledgements
The authors wish to thank the patients and staff at the National Rehabilitation Centre for their participation and to the NRC director general, Dr. Hamad Al Ghaferi, for his advice and support. Work on this study was included as part of H.E.'s doctoral studies and supervisor J.M. kindly acknowledge support from the Scholarship Office at the Ministry of Presidential Affairs, United Arab Emirates.

Keywords

abstinence
adherence
buprenorphine
effectiveness
opioid use disorder
therapeutic drug monitoring

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1111/add.15394Licence: CC BY-NC-ND

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© 2021 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction. Addiction, 116, 2398–2408 RESEARCH REPORT doi:10.1111/add.15394 This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made https://creativecommons.org/licenses/by-nc-nd/4.0/
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Cite this

Elarabi, H. F., Shawky, M., Mustafa, N., Radwan, D., Elarasheed, A., Yousif Ali, A., Osman, M., Kashmar, A., Al Kathiri, H., Gawad, T., Kodera, A., Al Jneibi, M., Adem, A., Lee, A. J., & Marsden, J. (2021). Effectiveness of incentivised adherence and abstinence monitoring in buprenorphine maintenance: a pragmatic, randomised controlled trial. Addiction, 116(9), 2398-2408. https://doi.org/10.1111/add.15394

Elarabi, HF, Shawky, M, Mustafa, N, Radwan, D, Elarasheed, A, Yousif Ali, A, Osman, M, Kashmar, A, Al Kathiri, H, Gawad, T, Kodera, A, Al Jneibi, M, Adem, A, Lee, AJ & Marsden, J 2021, 'Effectiveness of incentivised adherence and abstinence monitoring in buprenorphine maintenance: a pragmatic, randomised controlled trial', Addiction, vol. 116, no. 9, pp. 2398-2408. https://doi.org/10.1111/add.15394

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

abstract = "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.",

keywords = "abstinence, adherence, buprenorphine, effectiveness, opioid use disorder, therapeutic drug monitoring",

author = "Elarabi, {Hesham Farouk} and Mansour Shawky and Nael Mustafa and Doaa Radwan and Abuelgasim Elarasheed and {Yousif Ali}, Ahmed and Mona Osman and Ahmed Kashmar and {Al Kathiri}, Helal and Tarek Gawad and Ayman Kodera and {Al Jneibi}, Mohammed and Abdu Adem and Lee, {Amanda J.} and John Marsden",

note = "Acknowledgements The authors wish to thank the patients and staff at the National Rehabilitation Centre for their participation and to the NRC director general, Dr. Hamad Al Ghaferi, for his advice and support. Work on this study was included as part of H.E.'s doctoral studies and supervisor J.M. kindly acknowledge support from the Scholarship Office at the Ministry of Presidential Affairs, United Arab Emirates. ",

year = "2021",

month = sep,

doi = "10.1111/add.15394",

language = "English",

volume = "116",

pages = "2398--2408",

journal = "Addiction",

issn = "0965-2140",

publisher = "Wiley-Blackwell",

number = "9",

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TY - JOUR

T1 - Effectiveness of incentivised adherence and abstinence monitoring in buprenorphine maintenance

T2 - a pragmatic, randomised controlled trial

AU - Elarabi, Hesham Farouk

AU - Shawky, Mansour

AU - Mustafa, Nael

AU - Radwan, Doaa

AU - Elarasheed, Abuelgasim

AU - Yousif Ali, Ahmed

AU - Osman, Mona

AU - Kashmar, Ahmed

AU - Al Kathiri, Helal

AU - Gawad, Tarek

AU - Kodera, Ayman

AU - Al Jneibi, Mohammed

AU - Adem, Abdu

AU - Lee, Amanda J.

AU - Marsden, John

N1 - Acknowledgements The authors wish to thank the patients and staff at the National Rehabilitation Centre for their participation and to the NRC director general, Dr. Hamad Al Ghaferi, for his advice and support. Work on this study was included as part of H.E.'s doctoral studies and supervisor J.M. kindly acknowledge support from the Scholarship Office at the Ministry of Presidential Affairs, United Arab Emirates.

PY - 2021/9

Y1 - 2021/9

N2 - 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.

AB - 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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KW - adherence

KW - buprenorphine

KW - effectiveness

KW - opioid use disorder

KW - therapeutic drug monitoring

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DO - 10.1111/add.15394

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AN - SCOPUS:85099745145

SN - 0965-2140

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SP - 2398

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JF - Addiction

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ER -

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

Abstract

Bibliographical note

Keywords

UN SDGs

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