NCT02124980

Brief Summary

If shown to be effective, the Recovery Line would provide an inexpensive, transportable, and easy to use treatment to improve substance abuse outcomes for medication assisted treatment. Given the high costs of relapse and continued drug use, improvement of treatment outcomes would provide substantial health, economic, and societal benefits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2014

Completed
1.5 years until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

1.4 years

First QC Date

April 24, 2014

Last Update Submit

June 28, 2017

Conditions

Drug DependenceSubstance Use Disorders

Keywords

Opioid Substitution TreatmentCognitive Behavioral TherapyMobile Health

Outcome Measures

Primary Outcomes (2)

  • urine screens

    bi-weekly urine screens negative for illicit drugs

    6 months

  • self reported drug use

    monthly days of self reported illicit drug abstinence

    6 months

Secondary Outcomes (2)

  • treatment retention

    6 months

  • coping behaviors

    6 months

Other Outcomes (2)

  • patient satisfaction

    6 months

  • type and amount of health and psychosocial services

    6 months

Study Arms (2)

Recovery Line plus Treatment-as-Usual (RL+TAU)

EXPERIMENTAL

The Recovery Line is an automated computer-based IVR system that provides CBT-based modules. The RL+TAU condition will include the customized therapeutic recommendations developed in Phase 1, and the contact reminders messages and time frame that maximized system use in Phase 2. Patients will receive an orientation, 24-hour access, encouragement to use the system from clinic staff reminder, and technical assistance line for system problems. Patients will receive 12 weeks of system access.

Behavioral: Recovery Line

Treatment-as-Usual

NO INTERVENTION

Treatment-as Usual involves daily methadone and associated psychosocial services. Patients are required to attend 1 group session per month and are encouraged to attend open drop-in groups available daily covering a range of topics.

Interventions

Recovery LineBEHAVIORAL
Also known as: Therapeutic interactive voice response, Therapeutic IVR, TIVR
Recovery Line plus Treatment-as-Usual (RL+TAU)

Eligibility Criteria

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

You may qualify if:

  • are at least 18 years old
  • currently receiving methadone maintenance treatment
  • illicit drug use in the past 14 days or a positive urine screen for any tested illicit drug.

You may not qualify if:

  • Current suicide or homicide risk
  • meet criteria for Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV current psychotic disorder, or bipolar disorder
  • Unable to read or understand English
  • Unable to complete the study because of anticipated incarceration or move
  • Life-threatening or unstable medical problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MRU, APT Foundation, Inc

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

  • Moore BA, Buono FD, Printz DMB, Lloyd DP, Fiellin DA, Cutter CJ, Schottenfeld RS, Barry DT. Customized recommendations and reminder text messages for automated, computer-based treatment during methadone. Exp Clin Psychopharmacol. 2017 Dec;25(6):485-495. doi: 10.1037/pha0000149.

    PMID: 29251978DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

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

April 24, 2014

First Posted

April 28, 2014

Study Start

November 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

July 2, 2017

Record last verified: 2017-06

Locations

US(1)