NCT01632982

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
219

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 4, 2012

Completed
12 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

3.3 years

First QC Date

June 29, 2012

Last Update Submit

September 13, 2017

Conditions

Opioid AbuseSubstance Abuse

Keywords

opioid abusesubstance abusemethadone maintenance treatmentmobile technologytechnology-based interventionbehavioral interventionpsychosocial treatment

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • other substance use

    6 months

  • coping skills

    6 months

  • readiness to change drug use

    6 months

  • heroin/opioid craving

    6 months

  • HIV risk behavior

    6 months

  • +1 more secondary outcomes

Study Arms (3)

standard treatment

OTHER

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

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

Behavioral: standard treatmentBehavioral: MTS (Mobile Therapeutic System)

mobile control

ACTIVE COMPARATOR

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

Behavioral: standard treatmentBehavioral: mobile control

Interventions

standard treatmentBEHAVIORAL

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

Mobile Therapeutic System (MTS)mobile controlstandard treatment
MTS (Mobile Therapeutic System)BEHAVIORAL

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

Mobile Therapeutic System (MTS)
mobile controlBEHAVIORAL

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

mobile control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • client enrolled in the study site's methadone maintenance program
  • within the first month of initiating methadone maintenance treatment
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bridge Plaza Treatment and Rehabilitation Clinic

Long Island City, New York, 11101, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Michelle Acosta, Ph.D.

    National Development and Research Institutes (NDRI)

    PRINCIPAL INVESTIGATOR

  • Lisa A. Marsch, Ph.D.

    Dartmouth College

    PRINCIPAL INVESTIGATOR

  • Honoria Guarino, Ph.D.

    National Development and Research Institutes (NDRI)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2012

First Posted

July 4, 2012

Study Start

July 1, 2013

Primary Completion

November 1, 2016

Study Completion

September 1, 2018

Last Updated

September 14, 2017

Record last verified: 2017-09

Locations

US(1)