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Mobile Psychosocial Interventions for MMT Clients (MobileMMT)

Primary Purpose

Opioid Abuse, Substance Abuse

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
standard treatment
MTS (Mobile Therapeutic System)
mobile control
Sponsored by
National Development and Research Institutes, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Abuse focused on measuring opioid abuse, substance abuse, methadone maintenance treatment, mobile technology, technology-based intervention, behavioral intervention, psychosocial treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bridge Plaza Treatment and Rehabilitation Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Active Comparator

Arm Label

standard treatment

Mobile Therapeutic System (MTS)

mobile control

Arm Description

the standard drug counseling offered to patients in methadone maintenance treatment at the study site

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

a mobile phone-based application that directs participants to the NIDA website's home page

Outcomes

Primary Outcome Measures

treatment retention
participants' retention in methadone maintenance treatment (MMT)
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])

Secondary Outcome Measures

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])
coping skills
participants' coping skills as measured by the Coping Strategies Scale (CSS)
readiness to change drug use
participants' readiness to change drug use, as measured by the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)
heroin/opioid craving
participants' craving for heroin and/or other opioids, as measured by the Heroin/Opiate Craving Questionnaire (HCQ)
HIV risk behavior
participants' HIV risk behavior as measured by the High Risk-Taking Behavior Scale (HRBS)
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])

Full Information

First Posted
June 29, 2012
Last Updated
September 13, 2017
Sponsor
National Development and Research Institutes, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01632982
Brief Title
Mobile Psychosocial Interventions for MMT Clients
Acronym
MobileMMT
Official Title
Providing Psychosocial Interventions to Substance Abusers Via Mobile Technology
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Development and Research Institutes, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Abuse, Substance Abuse
Keywords
opioid abuse, substance abuse, methadone maintenance treatment, mobile technology, technology-based intervention, behavioral intervention, psychosocial treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
219 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard treatment
Arm Type
Other
Arm Description
the standard drug counseling offered to patients in methadone maintenance treatment at the study site
Arm Title
Mobile Therapeutic System (MTS)
Arm Type
Experimental
Arm Description
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
Arm Title
mobile control
Arm Type
Active Comparator
Arm Description
a mobile phone-based application that directs participants to the NIDA website's home page
Intervention Type
Behavioral
Intervention Name(s)
standard treatment
Intervention Description
the standard drug counseling offered to patients at the study site's methadone maintenance program
Intervention Type
Behavioral
Intervention Name(s)
MTS (Mobile Therapeutic System)
Intervention Description
a novel, interactive, mobile phone-delivered psychosocial intervention designed to promote skills acquisition and reduce drug use among adults in methadone maintenance treatment
Intervention Type
Behavioral
Intervention Name(s)
mobile control
Intervention Description
a mobile phone-based application that directs participants to the NIDA website's homepage
Primary Outcome Measure Information:
Title
treatment retention
Description
participants' retention in methadone maintenance treatment (MMT)
Time Frame
6 months
Title
opioid use
Description
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])
Time Frame
6 months
Secondary Outcome Measure Information:
Title
other substance use
Description
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])
Time Frame
6 months
Title
coping skills
Description
participants' coping skills as measured by the Coping Strategies Scale (CSS)
Time Frame
6 months
Title
readiness to change drug use
Description
participants' readiness to change drug use, as measured by the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)
Time Frame
6 months
Title
heroin/opioid craving
Description
participants' craving for heroin and/or other opioids, as measured by the Heroin/Opiate Craving Questionnaire (HCQ)
Time Frame
6 months
Title
HIV risk behavior
Description
participants' HIV risk behavior as measured by the High Risk-Taking Behavior Scale (HRBS)
Time Frame
6 months
Title
psychiatric and psychosocial functioning
Description
participants' level of psychiatric functioning (as assessed by the Brief Symptom Inventory [BSI]) and psychosocial functioning (as assessed by the Addiction Severity Index [ASI])
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Acosta, Ph.D.
Organizational Affiliation
National Development and Research Institutes (NDRI)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa A. Marsch, Ph.D.
Organizational Affiliation
Dartmouth College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Honoria Guarino, Ph.D.
Organizational Affiliation
National Development and Research Institutes (NDRI)
Official's Role
Study Director
Facility Information:
Facility Name
Bridge Plaza Treatment and Rehabilitation Clinic
City
Long Island City
State/Province
New York
ZIP/Postal Code
11101
Country
United States

12. IPD Sharing Statement

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Mobile Psychosocial Interventions for MMT Clients

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