Skip to main content
Top
Published in: Addiction Science & Clinical Practice 1/2020

Open Access 01-12-2020 | Buprenorphine | Study Protocol

Development of an integrated digital health intervention to promote engagement in and adherence to medication for opioid use disorder

Authors: Kirsten J. Langdon, Susan Ramsey, Caroline Scherzer, Kate Carey, Megan L. Ranney, Josiah Rich

Published in: Addiction Science & Clinical Practice | Issue 1/2020

Login to get access

Abstract

Background

Buprenorphine-naloxone is an evidence-based treatment for Opioid Use Disorder. However, despite its efficacy, nearly half of participants are unsuccessful in achieving stabilization (i.e., period of time following medication induction in which medication dose is adjusted to be effective in reducing cravings/withdrawal, minimize potential side effects, and eliminate illicit substance use). This paper presents the study design and protocol for a digital health intervention designed to promote engagement in and adherence to buprenorphine treatment, offered through an outpatient addiction treatment center, through motivational enhancement and distress tolerance skills training. Personalized feedback interventions represent a promising method to effectively motivate engagement in and adherence to buprenorphine treatment. These interventions are generally brief, individually tailored, and have the potential to be delivered via mobile platforms. Distress tolerance, a transdiagnostic vulnerability factor, has been implicated in the development and maintenance of substance use. Targeting distress tolerance may improve substance use treatment outcomes by promoting the ability to persist in goal-directed activity even when experiencing physical or emotional distress.

Methods

The study aims are to: (1) develop and refine an interactive computer- and text message-delivered personalized feedback intervention that incorporates distress tolerance skills training for persons who have elected to initiate outpatient buprenorphine treatment (iCOPE); (2) examine the feasibility, acceptability, and preliminary efficacy of iCOPE for increasing abstinence, adherence, and retention in treatment compared to a treatment as usual comparison condition; and, (3) examine potential mechanisms that may underlie the efficacy of iCOPE in improving outcomes, including motivation, distress tolerance, self-regulation, and negative affect.

Discussion

Results of this study will be used to determine whether to proceed with further testing through a large-scale trial. This work has the potential to improve treatment outcomes by reducing illicit opioid use, increasing adherence/retention, and preventing future overdose and other complications of illicit opioid use.
Trial Registration NCT03842384
Literature
1.
go back to reference Scholl L, Seth P, Kariisa M, Wilson N, Baldwin G. Drug and opioid-involved overdose deaths–United States, 2013–2017. Morb Mortal Wkly Rep. 2018;67:1419–27. Scholl L, Seth P, Kariisa M, Wilson N, Baldwin G. Drug and opioid-involved overdose deaths–United States, 2013–2017. Morb Mortal Wkly Rep. 2018;67:1419–27.
2.
go back to reference 2017 National Survey on Drug Use and Health, Mortality in the United States; 2016. 2017 National Survey on Drug Use and Health, Mortality in the United States; 2016.
3.
go back to reference National Academies of Sciences, Engineering, and Medicine; 2019. National Academies of Sciences, Engineering, and Medicine; 2019.
4.
go back to reference Boothby LA, Doering PL. Buprenorphine for the treatment of opioid dependence. Am J Health Syst Pharm. 2007;64:266–72.PubMedCrossRef Boothby LA, Doering PL. Buprenorphine for the treatment of opioid dependence. Am J Health Syst Pharm. 2007;64:266–72.PubMedCrossRef
6.
go back to reference Thomas CP, Fullerton CA, Kim M, Montejano L, Lyman DR, Dougherty RH, et al. Medication-assisted treatment with buprenorphine: assessing the evidence. Psychiatric Serv. 2014;65:158–70.CrossRef Thomas CP, Fullerton CA, Kim M, Montejano L, Lyman DR, Dougherty RH, et al. Medication-assisted treatment with buprenorphine: assessing the evidence. Psychiatric Serv. 2014;65:158–70.CrossRef
7.
go back to reference Hser YI, Saxon AJ, Huang D, Hasson A, Thomas C, Hillhouse M, et al. Treatment retention among patients randomized to buprenorphine/naloxone compared to methadone in a multi-site trial. Addiction. 2014;109:79–87.PubMedCrossRef Hser YI, Saxon AJ, Huang D, Hasson A, Thomas C, Hillhouse M, et al. Treatment retention among patients randomized to buprenorphine/naloxone compared to methadone in a multi-site trial. Addiction. 2014;109:79–87.PubMedCrossRef
8.
go back to reference Stein MD, Herman DS, Kettavong M, Cioe PA, Friedmann PD, Tellioglu T, et al. Antidepressant treatment does not improve buprenorphine retention among opioid-dependent persons. J Subst Abuse Treat. 2010;39:157–66.PubMedPubMedCentralCrossRef Stein MD, Herman DS, Kettavong M, Cioe PA, Friedmann PD, Tellioglu T, et al. Antidepressant treatment does not improve buprenorphine retention among opioid-dependent persons. J Subst Abuse Treat. 2010;39:157–66.PubMedPubMedCentralCrossRef
9.
go back to reference Novak A, Burgess ES, Clark M, Zvolensky MJ, Brown RA. Anxiety sensitivity, self-reported motives for alcohol and nicotine use, and level of consumption. J Anxiety Disord. 2003;17:165–80.PubMedCrossRef Novak A, Burgess ES, Clark M, Zvolensky MJ, Brown RA. Anxiety sensitivity, self-reported motives for alcohol and nicotine use, and level of consumption. J Anxiety Disord. 2003;17:165–80.PubMedCrossRef
11.
go back to reference Brown RA, Lejuez CW, Kahler CW, Strong DR. Distress tolerance and duration of past smoking cessation attempts. J Abnorm Psychol. 2002;111:180–5.PubMedCrossRef Brown RA, Lejuez CW, Kahler CW, Strong DR. Distress tolerance and duration of past smoking cessation attempts. J Abnorm Psychol. 2002;111:180–5.PubMedCrossRef
12.
go back to reference Lejuez CW, Paulson A, Daughters SB, Bornovalova MA, Zvolensky MJ. The association between heroin use and anxiety sensitivity among inner-city individuals in residential drug use treatment. Behav Res Ther. 2006;44:667–77.PubMedCrossRef Lejuez CW, Paulson A, Daughters SB, Bornovalova MA, Zvolensky MJ. The association between heroin use and anxiety sensitivity among inner-city individuals in residential drug use treatment. Behav Res Ther. 2006;44:667–77.PubMedCrossRef
13.
go back to reference Trafton JA, Gifford EV. Behavioral reactivity and addiction: the adaptation of behavioral response to reward opportunities. J Neuropsychiatry Clin Neurosci. 2008;20:23–35.PubMedCrossRef Trafton JA, Gifford EV. Behavioral reactivity and addiction: the adaptation of behavioral response to reward opportunities. J Neuropsychiatry Clin Neurosci. 2008;20:23–35.PubMedCrossRef
14.
go back to reference McHugh RK, Otto MW. Profiles of distress intolerance in a substance-dependent sample. Am J Drug Alcohol Abuse. 2012;38:161–5.PubMedCrossRef McHugh RK, Otto MW. Profiles of distress intolerance in a substance-dependent sample. Am J Drug Alcohol Abuse. 2012;38:161–5.PubMedCrossRef
15.
go back to reference McHugh RK, Weiss RD, Cornelius M, Martel MO, Jamison RN, Edwards RR. Distress intolerance and prescription opioid misuse among patients with chronic pain. J Pain. 2016;17:806–14.PubMedPubMedCentralCrossRef McHugh RK, Weiss RD, Cornelius M, Martel MO, Jamison RN, Edwards RR. Distress intolerance and prescription opioid misuse among patients with chronic pain. J Pain. 2016;17:806–14.PubMedPubMedCentralCrossRef
16.
go back to reference Daughters SB, Lejuez CW, Bornovalova MA, Kahler CW, Strong DR, Brown RA. Distress tolerance as a predictor of early treatment dropout in a residential substance abuse treatment facility. J Abnormal Psychol. 2005;114(4):729.CrossRef Daughters SB, Lejuez CW, Bornovalova MA, Kahler CW, Strong DR, Brown RA. Distress tolerance as a predictor of early treatment dropout in a residential substance abuse treatment facility. J Abnormal Psychol. 2005;114(4):729.CrossRef
17.
go back to reference Strong DR, Brown RA, Sims M, Herman DS, Anderson BJ, Stein MD. Persistence during stress-challenge predicts lapse to opiate use during buprenorphine treatment. J Addiction Med. 2012;6:19–25. Strong DR, Brown RA, Sims M, Herman DS, Anderson BJ, Stein MD. Persistence during stress-challenge predicts lapse to opiate use during buprenorphine treatment. J Addiction Med. 2012;6:19–25.
18.
go back to reference Daughters SB, Lejuez CW, Kahler CW, Strong DR, Brown RA. Psychological distress tolerance and duration of most recent abstinence attempt among residential treatment-seeking substance abusers. Psychol Addictive Behaviors. 2005;19(2):208.CrossRef Daughters SB, Lejuez CW, Kahler CW, Strong DR, Brown RA. Psychological distress tolerance and duration of most recent abstinence attempt among residential treatment-seeking substance abusers. Psychol Addictive Behaviors. 2005;19(2):208.CrossRef
19.
go back to reference Bornovalova MA, Gratz KL, Daughters SB, Hunt ED, Lejuez CW. Initial RCT of a distress tolerance treatment for individuals with substance use disorders. Drug Alcohol Depend. 2012;122:70–6.PubMedCrossRef Bornovalova MA, Gratz KL, Daughters SB, Hunt ED, Lejuez CW. Initial RCT of a distress tolerance treatment for individuals with substance use disorders. Drug Alcohol Depend. 2012;122:70–6.PubMedCrossRef
20.
go back to reference Janis IL, Mann L. Decision-making: a psychological analysis of conflict, choice, and commitment. New York: The Free Press; 1997. Janis IL, Mann L. Decision-making: a psychological analysis of conflict, choice, and commitment. New York: The Free Press; 1997.
21.
go back to reference Collins SE, Kirouac M, Lewis MA, Witkiewitz K, Carey KB. Randomized controlled trial of web-based decisional balance feedback and personalized normative feedback for college drinkers. J studies Alcohol Drugs. 2014;75(6):982–92.CrossRef Collins SE, Kirouac M, Lewis MA, Witkiewitz K, Carey KB. Randomized controlled trial of web-based decisional balance feedback and personalized normative feedback for college drinkers. J studies Alcohol Drugs. 2014;75(6):982–92.CrossRef
22.
go back to reference Lee CM, Neighbors C, Kilmer JR, Larimer ME. A brief, web-based personalized feedback selective intervention for college student marijuana use: a randomized clinical trial. Psychol Addict Behav. 2010;24:265–73.PubMedPubMedCentralCrossRef Lee CM, Neighbors C, Kilmer JR, Larimer ME. A brief, web-based personalized feedback selective intervention for college student marijuana use: a randomized clinical trial. Psychol Addict Behav. 2010;24:265–73.PubMedPubMedCentralCrossRef
24.
go back to reference Head KJ, Noar SM, Iannarino NT, Harrington NG. Efficacy of text message-based interventions for health promotion: a meta-analysis. Soc Sci Med. 2013;97:41–8.PubMedCrossRef Head KJ, Noar SM, Iannarino NT, Harrington NG. Efficacy of text message-based interventions for health promotion: a meta-analysis. Soc Sci Med. 2013;97:41–8.PubMedCrossRef
25.
go back to reference Muench F, Weiss RA, Kuerbis A, Morgenstern J. Developing a theory driven text messaging intervention for addiction care with user driven content. Psychol Addictive Behavior. 2013;27:315–21.CrossRef Muench F, Weiss RA, Kuerbis A, Morgenstern J. Developing a theory driven text messaging intervention for addiction care with user driven content. Psychol Addictive Behavior. 2013;27:315–21.CrossRef
26.
go back to reference Onken LS, Carroll KM, Shoham V, Cuthbert BN, Riddle M. Re-envisioning clinical science: unifying the discipline to improve the public health. Clin Psychol Sci. 2014;2(1):22–34.PubMedPubMedCentralCrossRef Onken LS, Carroll KM, Shoham V, Cuthbert BN, Riddle M. Re-envisioning clinical science: unifying the discipline to improve the public health. Clin Psychol Sci. 2014;2(1):22–34.PubMedPubMedCentralCrossRef
27.
go back to reference Ritchie J, et al. Qualitative research practice: a guide for social science students and researchers. Tucson: Sage Publishing; 2013. Ritchie J, et al. Qualitative research practice: a guide for social science students and researchers. Tucson: Sage Publishing; 2013.
28.
go back to reference Gale NK, et al. Using the framework method for the analysis of qualitative data in multidisciplinary health research. BMC Med Res Methodol. 2013;13:117.PubMedPubMedCentralCrossRef Gale NK, et al. Using the framework method for the analysis of qualitative data in multidisciplinary health research. BMC Med Res Methodol. 2013;13:117.PubMedPubMedCentralCrossRef
29.
30.
go back to reference Brooker J. Digital Equipment Co Ltd. United Kingdom: Reading; 1986. Brooker J. Digital Equipment Co Ltd. United Kingdom: Reading; 1986.
31.
go back to reference Bevan N, Kirakowski J, Maissel J. What is Usability? In: Bullinger H-J, editor. Human aspects in computing: design and use of interactive systems and work with terminals. Amsterdam: Elsevier; 1991. Bevan N, Kirakowski J, Maissel J. What is Usability? In: Bullinger H-J, editor. Human aspects in computing: design and use of interactive systems and work with terminals. Amsterdam: Elsevier; 1991.
32.
go back to reference Kirakowski J, Corbett M. Measuring User Satisfaction. In: Jones DM, Winder R, editors. People and Computers IV. Cambridge: Cambridge University Press; 1988. Kirakowski J, Corbett M. Measuring User Satisfaction. In: Jones DM, Winder R, editors. People and Computers IV. Cambridge: Cambridge University Press; 1988.
33.
go back to reference Picard RW, Liu KK. Relative subject count and assessment of interruptive technologies applied to mobile monitoring of stress. Int J Hum Comput Stud. 2007;65:361–75.CrossRef Picard RW, Liu KK. Relative subject count and assessment of interruptive technologies applied to mobile monitoring of stress. Int J Hum Comput Stud. 2007;65:361–75.CrossRef
34.
go back to reference Ranney ML, Pittman SK, Dunsiger S, Guthrie KM, Spirito A, Boyer EW, Cunningham RM. Emergency department text messaging for adolescent violence and depression prevention: a pilot randomized controlled trial. Psychol Serv. 2018;15(4):419.PubMedPubMedCentralCrossRef Ranney ML, Pittman SK, Dunsiger S, Guthrie KM, Spirito A, Boyer EW, Cunningham RM. Emergency department text messaging for adolescent violence and depression prevention: a pilot randomized controlled trial. Psychol Serv. 2018;15(4):419.PubMedPubMedCentralCrossRef
35.
go back to reference Ranney ML, Freeman JR, Connell G, Spirito A, Boyer E, Walton M, Guthrie KM, Cunningham RM. A depression prevention intervention for adolescents in the emergency department. J Adolescent Health. 2016;59:401–10.CrossRef Ranney ML, Freeman JR, Connell G, Spirito A, Boyer E, Walton M, Guthrie KM, Cunningham RM. A depression prevention intervention for adolescents in the emergency department. J Adolescent Health. 2016;59:401–10.CrossRef
36.
go back to reference Gold SM. Control conditions for randomised trials of behavioural interventions in psychiatry: a decision framework. Lancet Psychiatry. 2017;4(9):725–32.PubMedCrossRef Gold SM. Control conditions for randomised trials of behavioural interventions in psychiatry: a decision framework. Lancet Psychiatry. 2017;4(9):725–32.PubMedCrossRef
37.
go back to reference Robinson SM, Sobell LC, Sobell MB, Leo GI. Reliability of the timeline followback for cocaine, cannabis, and cigarette use. Psychol Addict Behav. 2014;28:154–62.PubMedCrossRef Robinson SM, Sobell LC, Sobell MB, Leo GI. Reliability of the timeline followback for cocaine, cannabis, and cigarette use. Psychol Addict Behav. 2014;28:154–62.PubMedCrossRef
38.
go back to reference Hjorthøj CR, Hjorthøj AR, Nordentoft M. Validity of timeline follow-back for self-reported use of cannabis and other illicit substances—systematic review and meta-analysis. Addictive Behaiors. 2012;37:225–33.CrossRef Hjorthøj CR, Hjorthøj AR, Nordentoft M. Validity of timeline follow-back for self-reported use of cannabis and other illicit substances—systematic review and meta-analysis. Addictive Behaiors. 2012;37:225–33.CrossRef
39.
go back to reference Hesse M. The Readiness Ruler as a measure of readiness to change poly-drug use in drug abusers. Harm Reduction J. 2006;3:3.CrossRef Hesse M. The Readiness Ruler as a measure of readiness to change poly-drug use in drug abusers. Harm Reduction J. 2006;3:3.CrossRef
40.
go back to reference Simons JS, Gaher RM. The distress tolerance scale: development and validation of a self-report measure. Motivation Emotion. 2005;29:83–102.CrossRef Simons JS, Gaher RM. The distress tolerance scale: development and validation of a self-report measure. Motivation Emotion. 2005;29:83–102.CrossRef
41.
go back to reference Strong DR, Lejuez CW, Daughters SB, Marinello M., Kahler CW, Brown RA. The computerized mirror tracing task version 1: Unpublished manual; 2003. Strong DR, Lejuez CW, Daughters SB, Marinello M., Kahler CW, Brown RA. The computerized mirror tracing task version 1: Unpublished manual; 2003.
42.
go back to reference Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988;54:1063–70.PubMedCrossRef Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988;54:1063–70.PubMedCrossRef
43.
go back to reference Gratz KL, Roemer L. Multidimensional assessment of emotion regulation and dysregulation: development, factor structure, and initial validation of the difficulties in emotion regulation scale. J Psychopathol Behav Assess. 2004;36:41–54.CrossRef Gratz KL, Roemer L. Multidimensional assessment of emotion regulation and dysregulation: development, factor structure, and initial validation of the difficulties in emotion regulation scale. J Psychopathol Behav Assess. 2004;36:41–54.CrossRef
44.
go back to reference Whiteside SP, Lynam DR. The five factor model and impulsivity: using a structural model of personality to understand impulsivity. Personality Individ Differ. 2001;30:669–89.CrossRef Whiteside SP, Lynam DR. The five factor model and impulsivity: using a structural model of personality to understand impulsivity. Personality Individ Differ. 2001;30:669–89.CrossRef
45.
go back to reference Larsen DL, Attkisson C, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Evalu Program Plan. 1979;2:197–207.CrossRef Larsen DL, Attkisson C, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Evalu Program Plan. 1979;2:197–207.CrossRef
46.
go back to reference Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA. Caution regarding the use of pilot studies to guide power calculations for study proposals. Arch Gen Psychiatry. 2006;63:484–9.PubMedCrossRef Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA. Caution regarding the use of pilot studies to guide power calculations for study proposals. Arch Gen Psychiatry. 2006;63:484–9.PubMedCrossRef
47.
go back to reference Papke LE, Wooldridge JM. Panel data methods for fractional response variables with an application to test pass rates. J Econ. 2008;145:121–33.CrossRef Papke LE, Wooldridge JM. Panel data methods for fractional response variables with an application to test pass rates. J Econ. 2008;145:121–33.CrossRef
48.
go back to reference Hall SM, Delucchi KL, Velicer WF, Kahler CW, Ranger-Moore J, Hedeker D, Tsoh JY, Niaura R. Statistical analysis of randomized trials in tobacco treatment: longitudinal designs with dichotomous outcome. Nicotine Tob Res. 2001;3:193–202.PubMedCrossRef Hall SM, Delucchi KL, Velicer WF, Kahler CW, Ranger-Moore J, Hedeker D, Tsoh JY, Niaura R. Statistical analysis of randomized trials in tobacco treatment: longitudinal designs with dichotomous outcome. Nicotine Tob Res. 2001;3:193–202.PubMedCrossRef
49.
go back to reference LIang K-Y, Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika. 1986;73:13-22. LIang K-Y, Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika. 1986;73:13-22.
50.
go back to reference Centers for Disease Control. Increases in drug and opioid overdose deaths United States, 2000–2014. Morb Mortal Wkly Rep. 2016;64:1378–82.CrossRef Centers for Disease Control. Increases in drug and opioid overdose deaths United States, 2000–2014. Morb Mortal Wkly Rep. 2016;64:1378–82.CrossRef
51.
go back to reference Connock M, Juarez-Garcia A, Jowett S, Frew E, Liu Z, Taylor RJ, et al. Methadone and buprenorphine for the management of opioid dependence: a systematic review and economic evaluation. Health Technol Assess. 2007;11:1–171.PubMed Connock M, Juarez-Garcia A, Jowett S, Frew E, Liu Z, Taylor RJ, et al. Methadone and buprenorphine for the management of opioid dependence: a systematic review and economic evaluation. Health Technol Assess. 2007;11:1–171.PubMed
53.
go back to reference Carroll KM, Weiss RD. The role of behavioral interventions in buprenorphine maintenance treatment: a review. Am J Psychiatry. 2017;174:738–47.PubMedCrossRef Carroll KM, Weiss RD. The role of behavioral interventions in buprenorphine maintenance treatment: a review. Am J Psychiatry. 2017;174:738–47.PubMedCrossRef
54.
go back to reference Brown RA, Bloom EL, Hecht J, Moitra E, Herman DS, Stein MD. A pilot study of stress tolerance treatment for opiate dependent patients initiating buprenorphine: rationale, methodology, and outcomes. Behavior Modif. 2016;38:730–59.CrossRef Brown RA, Bloom EL, Hecht J, Moitra E, Herman DS, Stein MD. A pilot study of stress tolerance treatment for opiate dependent patients initiating buprenorphine: rationale, methodology, and outcomes. Behavior Modif. 2016;38:730–59.CrossRef
55.
go back to reference Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011;45:626–9.PubMedCrossRef Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011;45:626–9.PubMedCrossRef
Metadata
Title
Development of an integrated digital health intervention to promote engagement in and adherence to medication for opioid use disorder
Authors
Kirsten J. Langdon
Susan Ramsey
Caroline Scherzer
Kate Carey
Megan L. Ranney
Josiah Rich
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Addiction Science & Clinical Practice / Issue 1/2020
Electronic ISSN: 1940-0640
DOI
https://doi.org/10.1186/s13722-020-00189-4

Other articles of this Issue 1/2020

Addiction Science & Clinical Practice 1/2020 Go to the issue