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Mobile Psychosocial Interventions for MMT Clients (MobileMMT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Development and Research Institutes, Inc.
ClinicalTrials.gov Identifier:
NCT01632982
First received: June 29, 2012
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Opioid Abuse
Substance Abuse
Behavioral: standard treatment
Behavioral: MTS (Mobile Therapeutic System)
Behavioral: mobile control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Providing Psychosocial Interventions to Substance Abusers Via Mobile Technology

Resource links provided by NLM:


Further study details as provided by National Development and Research Institutes, Inc.:

Primary Outcome Measures:
  • treatment retention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    participants' retention in methadone maintenance treatment (MMT)

  • opioid use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    participants' coping skills as measured by the Coping Strategies Scale (CSS)

  • readiness to change drug use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    participants' readiness to change drug use, as measured by the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)

  • heroin/opioid craving [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    participants' craving for heroin and/or other opioids, as measured by the Heroin/Opiate Craving Questionnaire (HCQ)

  • HIV risk behavior [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    participants' HIV risk behavior as measured by the High Risk-Taking Behavior Scale (HRBS)

  • psychiatric and psychosocial functioning [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    participants' level of psychiatric functioning (as assessed by the Brief Symptom Inventory [BSI]) and psychosocial functioning (as assessed by the Addiction Severity Index [ASI])


Estimated Enrollment: 219
Study Start Date: July 2013
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632982

Locations
United States, New York
Bridge Plaza Treatment and Rehabilitation Clinic
Long Island City, New York, United States, 11101
Sponsors and Collaborators
National Development and Research Institutes, Inc.
Investigators
Principal Investigator: Michelle Acosta, Ph.D. National Development and Research Institutes (NDRI)
Principal Investigator: Lisa A. Marsch, Ph.D. Dartmouth-Hitchcock Medical Center
Study Director: Honoria Guarino, Ph.D. National Development and Research Institutes (NDRI)
  More Information

No publications provided

Responsible Party: National Development and Research Institutes, Inc.
ClinicalTrials.gov Identifier: NCT01632982     History of Changes
Other Study ID Numbers: Mobile631, R01DA029630
Study First Received: June 29, 2012
Last Updated: September 25, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by National Development and Research Institutes, Inc.:
opioid abuse
substance abuse
methadone maintenance treatment
mobile technology
technology-based intervention
behavioral intervention
psychosocial treatment

Additional relevant MeSH terms:
Methadone
Analgesics
Analgesics, Opioid
Antitussive Agents
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014