Mobile Psychosocial Interventions for MMT Clients (MobileMMT)

Providing Psychosocial Interventions to Substance Abusers Via Mobile Technology

This study will develop and evaluate the preliminary efficacy and cost-effectiveness of a mobile phone-delivered psychosocial intervention for opioid-dependent adults (N=219) in methadone maintenance treatment (MMT). A three-arm, randomized clinical trial will evaluate the relative efficacy of: (1) standard MMT; (2) standard MMT plus the mobile intervention; and (3) a mobile-based control condition on the primary outcomes of treatment retention and opioid use (assessed via urine toxicology). If results are promising, this novel therapeutic tool may have a tremendous impact on improving access to and effectiveness of substance abuse treatment in a variety of other populations (and could also be adapted for an array of other behavioral health applications), while significantly limiting costs.

Study Overview

• Status: Unknown
• Conditions: Substance Abuse; Opioid Abuse
• Intervention / Treatment: Behavioral: standard treatment; Behavioral: MTS (Mobile Therapeutic System); Behavioral: mobile control

Detailed Description

This study will develop and implement a mobile technology-delivered psychosocial intervention for opioid-dependent adults in methadone maintenance treatment (MMT). This novel therapeutic system promises to be cost-effective and to enable the provision of flexible, on-demand therapeutic support outside of the formal treatment setting. The specific aims of this investigation are as follows: Aim 1: The investigators will develop a novel, interactive, evidence-based psychosocial intervention delivered via mobile phones, designed to promote skills acquisition and reduce illicit drug use. Specifically, our Mobile Therapeutic System (MTS) will offer key elements of a psychosocial intervention for substance use disorders of known efficacy (the Community Reinforcement Approach). Participants will be provided with unlimited daily prompts to encourage use of the program and will be able to access the application at any time and as much as they choose, within their natural environments. Our iterative development process will include input from focus groups with clients in methadone treatment (n=24), input from experts in the field, and feedback testing of a beta-version of the mobile phone-based program with clients in methadone treatment (n=30). Aim 2: The investigators will evaluate the efficacy of this mobile tool with participants entering MMT during the first three months of their treatment (n=219). The investigators will evaluate the relative preliminary efficacy of (1) standard treatment, (2) standard treatment plus MTS and (3) a mobile-based control condition on the primary outcomes of retention and opioid use (via urine toxicology) and secondary outcomes of other substance use (via urine toxicology and self-report), readiness to change drug use behavior, coping skills, opioid craving, HIV risk behavior, and psychosocial functioning during the 3-month intervention phase. Durability of effects will be examined at 1 and 3 month follow-ups. Aim 3: The investigators will perform an economic analysis of MTS in community-based MMT. The investigators will estimate the incremental costs and the incremental cost-effectiveness ratio (ICER) of MTS relative to standard care and the mobile control group. The primary ICER will be the incremental costs per increased abstinence time (the clinical measure of effectiveness) and the secondary ICER will be incremental costs per increased quality adjusted life year (QALY) (the economic measure of effectiveness). Cost data will be vital to future translational projects to disseminate effective mobile interventions in community systems. If results are promising, this novel therapeutic tool may have a tremendous impact on improving access to and effectiveness of substance abuse treatment in a variety of other populations (and could also be adapted for an array of other behavioral health applications), while significantly limiting costs.

• Study Type: Interventional
• Enrollment (Anticipated): 219
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Long Island City, New York, United States, 11101
      • Bridge Plaza Treatment and Rehabilitation Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• client enrolled in the study site's methadone maintenance program
• within the first month of initiating methadone maintenance treatment
• 18 years of age or older
• sufficient English-language ability to participate in informed consent process, complete study assessments and understand the text in mobile phone- delivered interventions

Exclusion Criteria:

• entering treatment at the study site with the intention of receiving a methadone-assisted withdrawal only
• evidence of an active psychiatric disorder requiring immediate intervention (e.g., suicidality, psychosis)
• evidence of significant mental illness that may preclude participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: standard treatment; the standard drug counseling offered to patients in methadone maintenance treatment at the study site	Behavioral: standard treatment; the standard drug counseling offered to patients at the study site's methadone maintenance program
Experimental: Mobile Therapeutic System (MTS); The Mobile Therapeutic System (MTS) is a novel, interactive, mobile phone-delivered psychosocial intervention designed to promote skills acquisition and reduce drug use among adults in methadone maintenance treatment	Behavioral: standard treatment; the standard drug counseling offered to patients at the study site's methadone maintenance program; Behavioral: MTS (Mobile Therapeutic System); a novel, interactive, mobile phone-delivered psychosocial intervention designed to promote skills acquisition and reduce drug use among adults in methadone maintenance treatment
Active Comparator: mobile control; a mobile phone-based application that directs participants to the NIDA website's home page	Behavioral: standard treatment; the standard drug counseling offered to patients at the study site's methadone maintenance program; Behavioral: mobile control; a mobile phone-based application that directs participants to the NIDA website's homepage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
treatment retention	participants' retention in methadone maintenance treatment (MMT)	6 months
opioid use	participants' illicit use of opioids, as measured by urine toxicology and self-report (self-report data collected via the timeline follow-back calendar assessment [TLFB])	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
other substance use	participants' use of alcohol and drugs, as measured by urine toxicology and self-report (self-report data collected via the timeline follow-back calendar assessment [TLFB])	6 months
coping skills	participants' coping skills as measured by the Coping Strategies Scale (CSS)	6 months
readiness to change drug use	participants' readiness to change drug use, as measured by the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)	6 months
heroin/opioid craving	participants' craving for heroin and/or other opioids, as measured by the Heroin/Opiate Craving Questionnaire (HCQ)	6 months
HIV risk behavior	participants' HIV risk behavior as measured by the High Risk-Taking Behavior Scale (HRBS)	6 months
psychiatric and psychosocial functioning	participants' level of psychiatric functioning (as assessed by the Brief Symptom Inventory [BSI]) and psychosocial functioning (as assessed by the Addiction Severity Index [ASI])	6 months

Collaborators and Investigators

• Sponsor: National Development and Research Institutes, Inc.
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Michelle Acosta, Ph.D., National Development and Research Institutes (NDRI); Principal Investigator: Lisa A. Marsch, Ph.D., Dartmouth College; Study Director: Honoria Guarino, Ph.D., National Development and Research Institutes (NDRI)

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): November 1, 2016
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: June 29, 2012
• First Submitted That Met QC Criteria: July 3, 2012
• First Posted (Estimate): July 4, 2012

Study Record Updates

• Last Update Posted (Actual): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: behavioral intervention; substance abuse; mobile technology; psychosocial treatment; technology-based intervention; methadone maintenance treatment; opioid abuse
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: Mobile631; R01DA029630 (U.S. NIH Grant/Contract)