Clinical trial NCT02124980: Automated Recovery Line for Medication Assisted Treatment
Official title: Automated Recovery Line for Medication Assisted Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Dependence
Substance Use Disorders
Keywords: Opioid Substitution Treatment
Cognitive Behavioral Therapy
Mobile Health
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: APT Foundation, Inc.
name: National Institute on Drug Abuse (NIDA)
First posted: 2014-04-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: urine screens
timeFrame: 6 months
measure: self reported drug use
timeFrame: 6 months
Secondary outcomes:
measure: treatment retention
timeFrame: 6 months
measure: coping behaviors
timeFrame: 6 months
Other outcomes:
measure: patient satisfaction
timeFrame: 6 months
measure: type and amount of health and psychosocial services
timeFrame: 6 months
Locations:
city: New Haven
country: United States
facility: MRU, APT Foundation, Inc
state: Connecticut
Study officials:
References:
citation: 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.