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Automated Recovery Line for Medication Assisted Treatment

Primary Purpose

Drug Dependence, Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Recovery Line
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Dependence focused on measuring Opioid Substitution Treatment, Cognitive Behavioral Therapy, Mobile Health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MRU, APT Foundation, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Recovery Line plus Treatment-as-Usual (RL+TAU)

Treatment-as-Usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

urine screens
bi-weekly urine screens negative for illicit drugs
self reported drug use
monthly days of self reported illicit drug abstinence

Secondary Outcome Measures

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

Full Information

First Posted
April 24, 2014
Last Updated
June 28, 2017
Sponsor
Yale University
Collaborators
APT Foundation, Inc., National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02124980
Brief Title
Automated Recovery Line for Medication Assisted Treatment
Official Title
Automated Recovery Line for Medication Assisted Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
APT Foundation, Inc., National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Dependence, Substance Use Disorders
Keywords
Opioid Substitution Treatment, Cognitive Behavioral Therapy, Mobile Health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recovery Line plus Treatment-as-Usual (RL+TAU)
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment-as-Usual
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Recovery Line
Other Intervention Name(s)
Therapeutic interactive voice response, Therapeutic IVR, TIVR
Primary Outcome Measure Information:
Title
urine screens
Description
bi-weekly urine screens negative for illicit drugs
Time Frame
6 months
Title
self reported drug use
Description
monthly days of self reported illicit drug abstinence
Time Frame
6 months
Secondary Outcome Measure Information:
Title
treatment retention
Description
days retained in methadone treatment
Time Frame
6 months
Title
coping behaviors
Description
coping behaviors as measured by the Effectiveness of Coping Behavior Inventory and the Drug Risk Response Test
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
patient satisfaction
Description
a semi-structured interview will be used to assess overall satisfaction with methadone services and satisfaction ratings of specific components of treatment
Time Frame
6 months
Title
type and amount of health and psychosocial services
Description
the Treatment Services Review is a semistructured used to collect detailed information on receipt of health and psychosocial services outside of the study
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: are at least 18 years old currently receiving methadone maintenance treatment illicit drug use in the past 14 days or a positive urine screen for any tested illicit drug. Exclusion Criteria: Current suicide or homicide risk meet criteria for Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV current psychotic disorder, or bipolar disorder Unable to read or understand English Unable to complete the study because of anticipated incarceration or move Life-threatening or unstable medical problems.
Facility Information:
Facility Name
MRU, APT Foundation, Inc
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29251978
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.
Results Reference
derived

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Automated Recovery Line for Medication Assisted Treatment

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