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.
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)
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Opioid Abuse, Substance Abuse
- 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 group | Role | What they receive |
|---|---|---|
| standard treatment | Other | the standard drug counseling offered to patients in methadone maintenance treatment at the study site Receives: Behavioral: standard treatment |
| Mobile Therapeutic System (MTS) | Experimental | 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 Receives: Behavioral: standard treatment; Behavioral: MTS (Mobile Therapeutic System) |
| mobile control | Active comparator | a 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.
treatment retention
participants' retention in methadone maintenance treatment (MMT)
Measured: 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])
Measured: 6 months
Secondary outcomes (6)
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
coping skills
participants' coping skills as measured by the Coping Strategies Scale (CSS)
Measured: 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)
Measured: 6 months
heroin/opioid craving
participants' craving for heroin and/or other opioids, as measured by the Heroin/Opiate Craving Questionnaire (HCQ)
Measured: 6 months
HIV risk behavior
participants' HIV risk behavior as measured by the High Risk-Taking Behavior Scale (HRBS)
Measured: 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])
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startJul 2013
- Primary completionNov 2016
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National Development and Research Institutes, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Michelle Acosta, Ph.D., Principal investigator, National Development and Research Institutes (NDRI)Lisa A. Marsch, Ph.D., Principal investigator, Dartmouth CollegeHonoria Guarino, Ph.D., Study director, National Development and Research Institutes (NDRI)
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Providing Psychosocial Interventions to Substance Abusers Via Mobile Technology
- ClinicalTrials.gov ID
- NCT01632982
- Acronym / sponsor ID
- MobileMMT / Mobile631
- Conditions
- Opioid Abuse, Substance Abuse
- Keywords
- opioid abuse, substance abuse, methadone maintenance treatment, mobile technology, technology-based intervention, behavioral intervention, psychosocial treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 219 participants (estimated)
- Lead sponsor
- National Development and Research Institutes, Inc.University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Sep 2018 (estimated)
- First posted
- 4 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard treatment | Other | Behavioral: standard treatmentthe standard drug counseling offered to patients in methadone maintenance treatment at the study site |
| Mobile Therapeutic System (MTS) | Experimental | Behavioral: standard treatment, Behavioral: MTS (Mobile Therapeutic System)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 |
| mobile control | Active comparator | Behavioral: standard treatment, Behavioral: mobile controla mobile phone-based application that directs participants to the NIDA website's home page |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard treatmentthe standard drug counseling offered to patients at the study site's methadone maintenance program | Behavioural | Mobile Therapeutic System (MTS), mobile control, standard treatment |
| 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 | Behavioural | Mobile Therapeutic System (MTS) |
| mobile controla mobile phone-based application that directs participants to the NIDA website's homepage | Behavioural | mobile control |
Primary outcome
treatment retention
Time frame: 6 months
participants' retention in methadone maintenance treatment (MMT)
opioid use
Time frame: 6 months
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 secondary outcomes
other substance use
Time frame: 6 months
coping skills
Time frame: 6 months
readiness to change drug use
Time frame: 6 months
heroin/opioid craving
Time frame: 6 months
HIV risk behavior
Time frame: 6 months
psychiatric and psychosocial functioning
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Acosta, Ph.D. principal investigator
National Development and Research Institutes (NDRI)
Lisa A. Marsch, Ph.D. principal investigator
Dartmouth College
Honoria Guarino, Ph.D. study director
National Development and Research Institutes (NDRI)
1 site in 1 country: see every site and its status.
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.