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Opioid AbuseMobileMMTNCT01632982

Mobile Psychosocial Interventions for MMT Clients

A study testing standard treatment and MTS (Mobile Therapeutic System) in people with Opioid Abuse and Substance Abuse, run by National Development and Research Institutes, Inc. at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Opioid Abuse, Substance Abuse
What is being tested?
standard treatment and MTS (Mobile Therapeutic System)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
219 participants
Where
1 siteUnited States
Study dates
Jul 2013to Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Bridge Plaza Treatment and Rehabilitation Clinic

    Long Island City, New York, 11101

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
standard treatment, MTS (Mobile Therapeutic System), mobile control
Keywords
opioid abuse, substance abuse, methadone maintenance treatment, mobile technology, technology-based intervention, behavioral intervention, psychosocial treatment
Medical subject headings
Opioid-Related Disorders, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • standard treatmentBehavioural

    the standard drug counseling offered to patients at the study site's methadone maintenance program

  • MTS (Mobile Therapeutic System)Behavioural

    a novel, interactive, mobile phone-delivered psychosocial intervention designed to promote skills acquisition and reduce drug use among adults in methadone maintenance treatment

  • mobile controlBehavioural

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

Study groups in NCT01632982
Study groupRoleWhat they receive
standard treatmentOtherthe standard drug counseling offered to patients in methadone maintenance treatment at the study site
Receives: Behavioral: standard treatment
Mobile Therapeutic System (MTS)ExperimentalThe 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
Receives: Behavioral: standard treatment; Behavioral: MTS (Mobile Therapeutic System)
mobile controlActive comparatora mobile phone-based application that directs participants to the NIDA website's home page
Receives: Behavioral: standard treatment; Behavioral: mobile control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. treatment retention

    participants' retention in methadone maintenance treatment (MMT)

    Measured: 6 months

  2. 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])

    Measured: 6 months

Secondary outcomes (6)
  1. 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])

    Measured: 6 months

  2. coping skills

    participants' coping skills as measured by the Coping Strategies Scale (CSS)

    Measured: 6 months

  3. readiness to change drug use

    participants' readiness to change drug use, as measured by the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)

    Measured: 6 months

  4. heroin/opioid craving

    participants' craving for heroin and/or other opioids, as measured by the Heroin/Opiate Craving Questionnaire (HCQ)

    Measured: 6 months

  5. HIV risk behavior

    participants' HIV risk behavior as measured by the High Risk-Taking Behavior Scale (HRBS)

    Measured: 6 months

  6. 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])

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2012 (estimated)
  2. Study startJul 2013
  3. Primary completionNov 2016
  4. Study completionSep 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
219 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01632982
Sponsor's protocol ID
Mobile631
Other IDs
R01DA029630
Acronym
MobileMMT
Status last verified
Sep 2017
First submitted
29 Jun 2012
Last updated
14 Sep 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing standard treatment and MTS (Mobile Therapeutic System) in people with Opioid Abuse and Substance Abuse, run by National Development and Research Institutes, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

treatment retention (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2017; AzTrials last refreshed its copy on 1 Nov 2026.

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