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.

Study Overview

• Status: Completed
• Conditions: Substance Use Disorders; Drug Dependence
• Intervention / Treatment: Behavioral: Recovery Line

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • MRU, APT Foundation, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Recovery Line plus Treatment-as-Usual (RL+TAU); 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; Other Names: Therapeutic interactive voice response; Therapeutic IVR; TIVR
No Intervention: Treatment-as-Usual; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
treatment retention	days retained in methadone treatment	6 months
coping behaviors	coping behaviors as measured by the Effectiveness of Coping Behavior Inventory and the Drug Risk Response Test	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction	a semi-structured interview will be used to assess overall satisfaction with methadone services and satisfaction ratings of specific components of treatment	6 months
type and amount of health and psychosocial services	the Treatment Services Review is a semistructured used to collect detailed information on receipt of health and psychosocial services outside of the study	6 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA); APT Foundation, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: April 24, 2014
• First Submitted That Met QC Criteria: April 25, 2014
• First Posted (Estimate): April 28, 2014

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Mobile Health; Cognitive Behavioral Therapy; Opioid Substitution Treatment
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 1208010744; R01DA034678 (U.S. NIH Grant/Contract)