Automated Recovery Line for Medication Assisted Treatment

Not Applicable

Completed

• Conditions: Drug Dependence; Substance Use Disorders
• Interventions: Behavioral: Recovery Line

• Registration Number: NCT02124980
• Lead Sponsor: Yale University

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.

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 Timeline

• Study First Submitted: 2014-04-24
• Study First Submitted QC: 2014-04-25
• Study First Posted: 2014-04-28
• Study Start: 2015-11
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-28
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recovery Line plus Treatment-as-Usual (RL+TAU)	Recovery Line	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.

Primary Outcome Measures

Name	Time	Method
urine screens	6 months	bi-weekly urine screens negative for illicit drugs
self reported drug use	6 months	monthly days of self reported illicit drug abstinence

Secondary Outcome Measures

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

Trial Locations

Locations (1)

MRU, APT Foundation, Inc; 🇺🇸 New Haven, Connecticut, United States