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Trials
Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

The effect of bundling medication-assisted treatment for opioid addiction with mHealth: study protocol for a randomized clinical trial

Authors: David H. Gustafson Sr, Gina Landucci, Fiona McTavish, Rachel Kornfield, Roberta A. Johnson, Marie-Louise Mares, Ryan P. Westergaard, Andrew Quanbeck, Esra Alagoz, Klaren Pe-Romashko, Chantelle Thomas, Dhavan Shah

Published in: Trials | Issue 1/2016

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Abstract

Background

Opioid dependence has devastating and increasingly widespread consequences and costs, and the most common outcome of treatment is early relapse. People who inject opioids are also at disproportionate risk for contracting the human immunodeficiency virus (HIV) and hepatitis C virus (HCV). This study tests an approach that has been shown to improve recovery rates: medication along with other supportive services (medication-assisted treatment, or MAT) against MAT combined with a smartphone innovation called A-CHESS (MAT + A-CHESS).

Methods/design

This unblinded study will randomly assign 440 patients to receive MAT + A-CHESS or MAT alone. Eligible patients will meet criteria for having an opioid use disorder of at least moderate severity and will be taking methadone, injectable naltrexone, or buprenorphine. Patients with A-CHESS will have smartphones for 16 months; all patients will be followed for 24 months. The primary outcome is the difference between patients in the two arms in percentage of days using illicit opioids during the 24-month intervention. Secondary outcomes are differences between patients receiving MAT + A-CHESS versus MAT in other substance use, quality of life, retention in treatment, health service use, and, related to HIV and HCV, screening and testing rates, medication adherence, risk behaviors, and links to care. We will also examine mediators and moderators of the effects of MAT + A-CHESS.
We will measure variables at baseline and months 4, 8, 12, 16, 20, and 24. At each point, patients will respond to a 20- to 30-min phone survey; urine screens will be collected at baseline and up to twice a month thereafter. We will use mixed-effects to evaluate the primary and secondary outcomes, with baseline scores functioning as covariates, treatment condition as a between-subject factor, and the outcomes reflecting scores for a given assessment at the six time points. Separate analyses will be conducted for each outcome.

Discussion

A-CHESS has been shown to improve recovery for people with alcohol dependence. It offers an adaptive and extensive menu of services and can attend to patients nearly as constantly as addiction does. This suggests the possibility of increasing both the effectiveness of, and access to, treatment for opioid dependence.

Trial registration

ClinicalTrials.gov, NCT02712034. Registered on 14 March 2016.
Appendix
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Literature
1.
Substance Abuse and Mental Health Services Administration (SAMHSA). Results from the 2012 National Survey on Drug Use and Health: Summary of National Findings. Rockville: Substance Abuse and Mental Health Services Administration; 2013.
2.
Volkow N, Director, National Institute on Drug Abuse (NIDA). America’s addiction to opioids: heroin and prescription drug abuse. Washington, DC: National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH); 2014.
3.
Substance Abuse and Mental Health Services Administration (SAMHSA). Drug Abuse Warning Network, 2007: national estimates of drug-related emergency department visits. Rockville: Substance Abuse and Mental Health Services Administration; 2008.
4.
News from the Centers for Disease Control and Prevention (CDC). Opioid overdoses continue to climb. JAMA. 2016;315(6):550.
5.
Conrad C, Bradley HM, Broz D, Buddha S, Chapman EL, Galang RR, et al. Community outbreak of HIV infection linked to injection drug use of oxymorphone—Indiana, 2015. MMWR. 2015;64(16):443–4.PubMed
6.
Zibbell JE, Iqbal K, Patel RC, Suryaprasad A, Sanders KJ, Moore-Moravian L, et al. Increases in hepatitis C virus infection related to injection drug use among persons aged ≤30 years—Kentucky, Tennessee, Virginia, and West Virginia, 2006–2012. MMWR. 2015;64(17):453–8.PubMed
7.
Kleber HD. Pharmacologic treatments for opioid dependence: detoxification and maintenance options. Dialogues Clin Neurosci. 2007;9(4):455.PubMedPubMedCentral
8.
Heron KE, Smyth JM. Ecological momentary interventions: incorporating mobile technology into psychosocial and health behaviour treatments. Br J Health Psychol. 2010;15(Pt 1):1–39.CrossRefPubMed
9.
Center for Substance Abuse Treatment (CSAT). Medication-assisted treatment for opioid addiction in opioid treatment programs. Rockville: U.S. Department of Health and Human Services (DHHS); 2005.
10.
11.
Substance Abuse and Mental Health Services Administration (SAMHSA). 2012 National Survey on Drug Use and Health: detailed tables – 5.1 to 5.56. Rockville: Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality; 2012.
12.
Brady KT, Back SE, Greenfield SF. Women and addiction: a comprehensive handbook. New York: Guilford Press; 2009
13.
Simpson DD, Joe GW, Brown BS. Treatment retention and follow-up outcomes in the Drug Abuse Treatment Outcome Study (DATOS). Psychol Addict Behav. 1997;11(4):294.CrossRef
14.
Brooks AC, Comer SD, Sullivan MA, Bisaga A, Carpenter KM, Raby WM, et al. Long-acting injectable versus oral naltrexone maintenance therapy with psychosocial intervention for heroin dependence: a quasi-experiment. J Clin Psychiatry. 2010;71(10):1371–8.CrossRefPubMedPubMedCentral
15.
Fiellin DA, Pantalon MV, Chawarski MC, Moore BA, Sullivan LE, O’Connor PG, et al. Counseling plus buprenorphine-naloxone maintenance therapy for opioid dependence. N Engl J Med. 2006;355(4):365–74.CrossRefPubMed
16.
Witkiewitz K, Marlatt GA. Relapse prevention for alcohol and drug problems: that was Zen, this is Tao. Am Psychol. 2004;59(4):224–35.CrossRefPubMed
17.
McKay JR, Weiss RV. A review of temporal effects and outcome predictors in substance abuse treatment studies with long-term follow-ups preliminary results and methodological issues. Eval Rev. 2001;25(2):113–61.CrossRefPubMed
18.
McLellan A. The outcomes movement in substance abuse treatment: comments, concerns and criticisms. In: Sorenson JL, Rawson RA, Guydish A, Zweben JE, editors. Drug abuse treatment through collaboration: practice and research partnerships that work. Washington, DC: American Psychological Association; 2002. p. 119–34.
19.
Bradizza CM, Stasiewicz PR, Paas ND. Relapse to alcohol and drug use among individuals diagnosed with co-occurring mental health and substance use disorders: a review. Clin Psychol Rev. 2006;26(2):162–78.CrossRefPubMed
20.
Zhang Z, Friedmann PD, Gerstein DR. Does retention matter? Treatment duration and improvement in drug use. Addiction. 2003;98(5):673–84.CrossRefPubMed
21.
Giordano TP, Gifford AL, White Jr AC, Suarez-Almazor ME, Rabeneck L, Hartman C, et al. Retention in care: a challenge to survival with HIV infection. Clin Infect Dis. 2007;44(11):1493–9.CrossRefPubMed
22.
Torian LV, Wiewel EW, Liu KL, Sackoff JE, Frieden TR. Risk factors for delayed initiation of medical care after diagnosis of human immunodeficiency virus. Arch Intern Med. 2008;168(11):1181–7.CrossRefPubMed
23.
Fleishman JA, Yehia BR, Moore RD, Korthuis PT, Gebo KA. Establishment, retention, and loss to follow-up in outpatient HIV care. J Acquir Immune Defic Syndr. 2012;60(3):249–59.CrossRefPubMedPubMedCentral
24.
Schepens T, Morreel S, Florence E, Koole O, Colebunders R. Incidence and risk factors associated with lost to follow-up in a Belgian cohort of HIV-infected patients treated with highly active antiretroviral therapy. Int J STD AIDS. 2010;21(11):765–9.CrossRefPubMed
25.
Torian LV, Wiewel EW. Continuity of HIV-related medical care, New York City, 2005–2009: do patients who initiate care stay in care? AIDS Patient Care STDS. 2011;25(2):79–88.CrossRefPubMed
26.
Westergaard RP, Hess T, Astemborski J, Mehta SH, Kirk GD. Longitudinal changes in engagement in care and viral suppression for HIV-infected injection drug users. AIDS. 2013;27(16):2559–66.CrossRefPubMedPubMedCentral
27.
Westergaard RP, Ambrose BK, Mehta SH, Kirk GD. Provider and clinic-level correlates of deferring antiretroviral therapy for people who inject drugs: a survey of North American HIV providers. J Int AIDS Soc. 2012;15(1):10.CrossRefPubMedPubMedCentral
28.
Hanna DB, Buchacz K, Gebo KA, Hessol NA, Horberg MA, Jacobson LP, et al. Trends and disparities in antiretroviral therapy initiation and virologic suppression among newly treatment-eligible HIV-infected individuals in North America, 2001-2009. Clin Infect Dis. 2013;56(8):1174–82.CrossRefPubMedPubMedCentral
29.
Weinbaum C, Lyerla R, Margolis H, Centers for Disease Control and Prevention. Prevention and control of infections with hepatitis viruses in correctional settings. Centers for Disease Control and Prevention. MMWR Recomm Rep. 2003;52(RR-1):1–36.PubMed
30.
Amon JJ, Garfein RS, Ahdieh-Grant L, Armstrong GL, Ouellet LJ, Latka MH, et al. Prevalence of hepatitis C virus infection among injection drug users in the United States, 1994–2004. Clin Infect Dis. 2008;46(12):1852–8.CrossRefPubMed
31.
Hagan H, Pouget ER, Des Jarlais DC, Lelutiu-Weinberger C. Meta-regression of hepatitis C virus infection in relation to time since onset of illicit drug injection: the influence of time and place. Am J Epidemiol. 2008;168(10):1099–109.CrossRefPubMedPubMedCentral
32.
Armstrong GL, Wasley A, Simard EP, McQuillan GM, Kuhnert WL, Alter MJ. The prevalence of hepatitis C virus infection in the United States, 1999 through 2002. Ann Intern Med. 2006;144(10):705–14.CrossRefPubMed
33.
Gustafson DH, McTavish FM, Chih MY, Atwood AK, Johnson RA, Boyle MG, et al. A smartphone application to support recovery from alcoholism: a randomized clinical trial. JAMA Psychiatry. 2014;71(5):566–72.CrossRefPubMedPubMedCentral
34.
Mathews D, Evaluation Consultant. Evaluation Report: combatting addiction with technology for pregnant Appalachian women using smartphones. Hazard: Kentucky River Community Care, Inc; 2014.
35.
Ryan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. Am Psychol. 2000;55(1):68–78.CrossRefPubMed
36.
Namkoong K, Shah DV, Han JY, Kim SC, Yoo W, Fan D, et al. Expression and reception of treatment information in breast cancer support groups: how health self-efficacy moderates effects on emotional well-being. Patient Educ Couns. 2010;81(Suppl):S41–7.CrossRefPubMed
37.
Ryan RM, Patrick H, Deci EL, Williams GC. Facilitating health behaviour change and its maintenance: interventions based on self-determination theory. Eur Health Psychol. 2008;10(1):2–5.
38.
Marlatt G, Gordon J. Relapse prevention: maintenance strategies in the treatment of addictive disorders. New York: Guilford Press; 1985.
39.
Larimer ME, Palmer RS, Marlatt GA. Relapse prevention. An overview of Marlatt’s cognitive-behavioral model. Alcohol Res Health. 1999;23(2):151–60.PubMed
40.
Dennis ML, Lennox R, Scott C, Funk R. Comparing the ability of multiple measures of substance abuse treatment process to predict outcomes. Drug Alcohol Depend. 2014;140:e48.CrossRef
41.
Grossman P, Niemann L, Schmidt S, Walach H. Mindfulness-based stress reduction and health benefits: a meta-analysis. J Psychosom Res. 2004;57(1):35–43.CrossRefPubMed
42.
Nelson KG, Young K, Chapman H. Examining the performance of the Brief Addiction Monitor. J Subst Abuse Treat. 2014;46(4):472–81.CrossRefPubMed
43.
Voogt C, Kuntsche E, Kleinjan M, Poelen E, Engels R. Using ecological momentary assessment to test the effectiveness of a web-based brief alcohol intervention over time among heavy-drinking students: randomized controlled trial. J Med Internet Res. 2014;16(1):e5.CrossRefPubMedPubMedCentral
44.
Krishna S, Boren SA, Balas EA. Healthcare via cell phones: a systematic review. Telemed J E Health. 2009;15(3):231–40.CrossRefPubMed
45.
Hawkins RP, Pingree S, Baker T, Roberts LJ, Shaw B, McDowell H, et al. Integrating eHealth with human services for breast cancer patients. Transl Behav Med. 2011;1(1):146–54.CrossRefPubMedPubMedCentral
46.
Quanbeck AR, Gustafson DH, Marsch LA, McTavish F, Brown RT, Mares ML, et al. Integrating addiction treatment into primary care using mobile health technology: protocol for an implementation research study. Implement Sci. 2014;9:65.CrossRefPubMedPubMedCentral
47.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81.CrossRefPubMed
48.
Keen J. Case studies. In: Pope C, Mays N, editors. Qualitative research in healthcare. London: Wiley; 2008. p. 112–20.
49.
Yin RK. Case study research: design and methods. 5th ed. Los Angeles: Sage Publications; 2014.
50.
51.
Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, et al. Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011;41(6):1073–93.CrossRefPubMed
52.
Donovan DM, Bigelow GE, Brigham GS, Carroll KM, Cohen AJ, Gardin JG, et al. Primary outcome indices in illicit drug dependence treatment research: systematic approach to selection and measurement of drug use end-points in clinical trials. Addiction. 2012;107(4):694–708.CrossRefPubMed
53.
Sobell LC, Brown J, Leo GI, Sobell MB. The reliability of the Alcohol Timeline Followback when administered by telephone and by computer. Drug Alcohol Depend. 1996;42(1):49–54.CrossRefPubMed
54.
Sobell LC, Maisto SA, Sobell MB, Cooper AM. Reliability of alcohol abusers’ self-reports of drinking behavior. Behav Res Ther. 1979;17(2):157–60.CrossRefPubMed
55.
Cacciola JS, Alterman AI, Dephilippis D, Drapkin ML, Valadez Jr C, Fala NC, et al. Development and initial evaluation of the Brief Addiction Monitor (BAM). J Subst Abuse Treat. 2013;44(3):256–63.CrossRefPubMed
56.
Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011;152(10):2399–404.CrossRefPubMed
57.
Darke S, Hall W, Heather N, Ward J, Wodak A. The reliability and validity of a scale to measure HIV risk-taking behaviour among intravenous drug users. AIDS. 1991;5(2):181–6.CrossRefPubMed
58.
Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction with Life Scale. J Pers Asses. 1985;49(1):71–5.CrossRef
59.
Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008;10(5):348–54.CrossRef
60.
Williams GC, Cox EM, Kouides R, Deci EL. Presenting the facts about smoking to adolescents: effects of an autonomy-supportive style. Arch Pediatr Adolesc Med. 1999;153(9):959–64.CrossRefPubMed
61.
Sklar SM, Annis HM, Turner NE. Development and validation of the Drug-Taking Confidence Questionnaire: a measure of coping self-efficacy. Addict Behav. 1997;22(5):655–70.CrossRefPubMed
62.
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(6):1063.CrossRefPubMed
63.
Measelle JR, Stice E, Springer DW. A prospective test of the negative affect model of substance abuse: moderating effects of social support. Psychol Addict Behav. 2006;20(3):225.CrossRefPubMedPubMedCentral
64.
Luoma JB, Nobles RH, Drake CE, Hayes SC, O’Hair A, Fletcher L, et al. Self-stigma in substance abuse: development of a new measure. J Psychopathol Behav Assess. 2013;35(2):223–34.CrossRefPubMed
65.
McCollister KE, French MT. The relative contribution of outcome domains in the total economic benefit of addiction interventions: a review of first findings. Addiction. 2003;98(12):1647–59.CrossRefPubMed
66.
67.
French MT, Popovici I, Tapsell L. The economic costs of substance abuse treatment: updated estimates and cost bands for program assessment and reimbursement. J Subst Abuse Treat. 2008;35(4):462–9.CrossRefPubMedPubMedCentral
68.
Bell J, Shanahan M, Mutch C, Rea F, Ryan A, Batey R, et al. A randomized trial of effectiveness and cost-effectiveness of observed versus unobserved administration of buprenorphine-naloxone for heroin dependence. Addiction. 2007;102(12):1899–907.CrossRefPubMed
69.
Hedeker D, Gibbons RD, Waternaux C. Sample size estimation for longitudinal designs with attrition: comparing time-related contrasts between two groups. J Educ Behav Stat. 1999;24(1):70–93.CrossRef
70.
Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. Hillsdale: Lawrence Erlbaum Associates; 1988.
71.
McKay JR, Lynch KG, Shepard DS, Ratichek S, Morrison R, Koppenhaver J, et al. The effectiveness of telephone-based continuing care in the clinical management of alcohol and cocaine use disorders: 12-month outcomes. J Consult Clin Psychol. 2004;72(6):967–79.CrossRefPubMed
72.
73.
Satorra A, Saris WE. Power of the likelihood ratio test in covariance structure analysis. Psychometrika. 1985;50(1):83–90.CrossRef
74.
Diggle P, Kenward MG. Informative drop-out in longitudinal data analysis. Appl Stat. 1994;43:49–93.CrossRef
75.
Hedeker D, Gibbons RD. Application of random-effects pattern-mixture models for missing data in longitudinal studies. Psychol Methods. 1997;2(1):64.CrossRef
76.
Hedeker D, Gibbons RD. Longitudinal data analysis. Hoboken: Wiley; 2006.
77.
Enders CK. Missing not at random models for latent growth curve analyses. Psychol Methods. 2011;16(1):1–16.CrossRefPubMed
78.
Birnbaum HG, White AG, Schiller M, Waldman T, Cleveland JM, Roland CL. Societal costs of prescription opioid abuse, dependence, and misuse in the United States. Pain Med. 2011;12(4):657–67.CrossRefPubMed
79.
Hedeker D, Mermelstein RJ, Demirtas H. Analysis of binary outcomes with missing data: missing = smoking, last observation carried forward, and a little multiple imputation. Addiction. 2007;102(10):1564–73.CrossRefPubMed
80.
Thabane L, Mbuagbaw L, Zhang S, Samaan Z, Marcucci M, Ye C, et al. A tutorial on sensitivity analyses in clinical trials: the what, why, when and how. BMC Med Res Methodol. 2013;13:92.CrossRefPubMedPubMedCentral
81.
Little RJ, Yau LHY. Statistical techniques for analyzing data from prevention trials: treatment of no-shows using Rubin’s causal model. Psychol Methods. 1998;3(2):147.CrossRef
82.
Jo B. Statistical power in randomized intervention studies with noncompliance. Psychol Methods. 2002;7(2):178–93.CrossRefPubMed
83.
84.
85.
Bolt DM, Piper ME, Theobald WE, Baker TB. Why two smoking cessation agents work better than one: role of craving suppression. J Consult Clin Psychol. 2012;80(1):54–65.CrossRefPubMed
86.
Mayring P. Qualitative content analysis. In: Flick U, Kardoff EV, Steinke I, editors. A companion to qualitative research. Thousand Oaks: Sage; 2004. p. 266–9.
87.
Berelson B. Content analysis in communication research. New York: Free Press; 1952.
Metadata
Title
The effect of bundling medication-assisted treatment for opioid addiction with mHealth: study protocol for a randomized clinical trial
Authors
David H. Gustafson Sr
Gina Landucci
Fiona McTavish
Rachel Kornfield
Roberta A. Johnson
Marie-Louise Mares
Ryan P. Westergaard
Andrew Quanbeck
Esra Alagoz
Klaren Pe-Romashko
Chantelle Thomas
Dhavan Shah
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1726-1

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