Automated Recovery Line for Medication Assisted Treatment

NCT ID: NCT02124980

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-04-30

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.

Conditions

Drug Dependence; Substance Use Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Recovery Line

Intervention Type: BEHAVIORAL

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Recovery Line

Intervention Type: BEHAVIORAL

Other Intervention Names

Therapeutic interactive voice response; Therapeutic IVR; TIVR

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

APT Foundation, Inc.

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MRU, APT Foundation, Inc

New Haven, Connecticut, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29251978 (View on PubMed)

Other Identifiers

R01DA034678

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1208010744

Identifier Type: -

Identifier Source: org_study_id