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Completed

NCT Number: NCT02124980

Automated Recovery Line for Medication Assisted Treatment

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MRU, APT Foundation, Inc

New Haven, Connecticut, 06519, United States

About this study

Dependence on heroin and prescription pain relievers has almost tripled since 2000, resulting in dramatic increases in opioid dependence treatment admissions. However, among agonist-maintained patients continued drug use is common and associated with high rates of relapse and treatment drop-out. Although counseling has been shown to be effective, it is costly and some patients dislike counseling, others have responsibilities that make attendance difficult, and patients in rural settings often have limited access to psychotherapy. Thus, there is a clear need to develop additional acceptable and cost-effective treatments. Interactive Voice Response (IVR) systems, which have been shown to effectively augment brief interventions for substance abuse, are automated, computer-based systems delivered via phone and use voice or keys to access different menus. IVR systems can be accessed from any phone rather than only specified technology (e.g., smartphones), and offer advantages of low cost, consistent delivery, expanded access, and 24-hour availability of immediate therapeutic intervention. The Recovery Line is a Cognitive Behavioral Therapy (CBT)-based IVR system to reduce substance use in patients receiving opioid agonist maintenance. We recently completed a pilot randomized 4-week trial which showed significant reduction in cocaine use and increased coping skill efficacy, but patients called less time than expected, suggesting methods to improve patient use may further improve efficacy. This Stage Ib application proposes three phases to develop system functions to increase patient system use and to test those functions. The initial two phases will develop customized recommendations and reminders to be used in Phase 3 pilot clinical trial. The Phase 3 trial is a 12-week pilot randomized (N=60), clinical trial with a 3 month post-treatment follow-up to obtain data regarding the feasibility, acceptability and efficacy of the developed Recovery Line (compared to TAU). Efficacy will be evaluated for the two primary outcome domains of the proportion of urine screens negative for illicit drugs and monthly days of illicit drug abstinence. Secondary outcome measures will be retention in treatment and coping skills efficacy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Recovery Line

Behavioral

Other names: Therapeutic interactive voice response, Therapeutic IVR, TIVR

Primary outcomes

  1. urine screens

    Time frame: 6 months

    bi-weekly urine screens negative for illicit drugs

  2. self reported drug use

    Time frame: 6 months

    monthly days of self reported illicit drug abstinence

Secondary outcomes

  1. treatment retention

    Time frame: 6 months

    days retained in methadone treatment

  2. coping behaviors

    Time frame: 6 months

    coping behaviors as measured by the Effectiveness of Coping Behavior Inventory and the Drug Risk Response Test

Other outcomes

  1. patient satisfaction

    Time frame: 6 months

    a semi-structured interview will be used to assess overall satisfaction with methadone services and satisfaction ratings of specific components of treatment

  2. type and amount of health and psychosocial services

    Time frame: 6 months

    the Treatment Services Review is a semistructured used to collect detailed information on receipt of health and psychosocial services outside of the study

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • APT Foundation, Inc.
  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 28, 2014
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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