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	1 Aug 2021
DOIs	https://doi.org/10.1111/add.15394
Publication status	Published - Sept 2021

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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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

@article{cd9014620c3c412793283cc6be5d62e0,

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 = "Funding Information: In the past 3 years, J.M. declares research grants to King's College London (KCL) from: (i) the National Institute for Health Research (NIHR) for a multi‐centre RCT of acamprosate for alcohol use disorder; (ii) the NIHR Biomedical Research Centre for Mental Health at South London and Maudsley NHS Mental Health Foundation Trust (SLaM) for a pilot RCT of novel cognitive therapy for cocaine use disorder; and (iii) an unrestricted grant from Indivior to KCL and SLaM from Indivior for a multi‐centre, RCT of extended‐release injectable buprenorphine for OUD. He has part‐time employment as Senior Academic Advisor for the Alcohol, Drugs, Tobacco and Justice Division, Health Improvement, Public Health England. He is a clinical academic consultant for the United States National Institute on Drug Abuse, Centre for Clinical Trials Network. He holds no stocks in any company. All other authors state they have no declarations of interests. Funding Information: 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. Publisher Copyright: {\textcopyright} 2021 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.",

year = "2021",

month = sep,

doi = "10.1111/add.15394",

language = "English",

volume = "116",

pages = "2398--2408",

journal = "Addiction",

issn = "0965-2140",

publisher = "Wiley-Blackwell Publishing Ltd",

number = "9",

}

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

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 - Funding Information: In the past 3 years, J.M. declares research grants to King's College London (KCL) from: (i) the National Institute for Health Research (NIHR) for a multi‐centre RCT of acamprosate for alcohol use disorder; (ii) the NIHR Biomedical Research Centre for Mental Health at South London and Maudsley NHS Mental Health Foundation Trust (SLaM) for a pilot RCT of novel cognitive therapy for cocaine use disorder; and (iii) an unrestricted grant from Indivior to KCL and SLaM from Indivior for a multi‐centre, RCT of extended‐release injectable buprenorphine for OUD. He has part‐time employment as Senior Academic Advisor for the Alcohol, Drugs, Tobacco and Justice Division, Health Improvement, Public Health England. He is a clinical academic consultant for the United States National Institute on Drug Abuse, Centre for Clinical Trials Network. He holds no stocks in any company. All other authors state they have no declarations of interests. Funding Information: 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. Publisher Copyright: © 2021 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

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.

KW - abstinence

KW - adherence

KW - buprenorphine

KW - effectiveness

KW - opioid use disorder

KW - therapeutic drug monitoring

UR - http://www.scopus.com/inward/record.url?scp=85099745145&partnerID=8YFLogxK

U2 - 10.1111/add.15394

DO - 10.1111/add.15394

M3 - Article

AN - SCOPUS:85099745145

SN - 0965-2140

VL - 116

SP - 2398

EP - 2408

JO - Addiction

JF - Addiction

IS - 9

ER -

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

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Keywords

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