Skip to content

Automated Recovery Line for Medication Assisted Treatment

Automated Recovery Line for Medication Assisted Treatment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02124980
Enrollment
60
Registered
2014-04-28
Start date
2015-11-30
Completion date
2017-04-30
Last updated
2017-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Dependence, Substance Use Disorders

Keywords

Opioid Substitution Treatment, Cognitive Behavioral Therapy, Mobile Health

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.

Interventions

BEHAVIORALRecovery Line

Sponsors

APT Foundation, Inc.
CollaboratorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
urine screens6 monthsbi-weekly urine screens negative for illicit drugs
self reported drug use6 monthsmonthly days of self reported illicit drug abstinence

Secondary

MeasureTime frameDescription
treatment retention6 monthsdays retained in methadone treatment
coping behaviors6 monthscoping behaviors as measured by the Effectiveness of Coping Behavior Inventory and the Drug Risk Response Test

Other

MeasureTime frameDescription
patient satisfaction6 monthsa semi-structured interview will be used to assess overall satisfaction with methadone services and satisfaction ratings of specific components of treatment
type and amount of health and psychosocial services6 monthsthe Treatment Services Review is a semistructured used to collect detailed information on receipt of health and psychosocial services outside of the study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026