Automated Recovery Line for Medication Assisted Treatment

Substance Use Disorders Clinical Trial

Official title:

Automated Recovery Line for Medication Assisted Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02124980
• Other study ID #: 1208010744
• Secondary ID: R01DA034678
• Status: Completed
• Phase: N/A
• First received: April 24, 2014
• Last updated: June 28, 2017
• Start date: November 2015
• Est. completion date: April 2017

Study information

• Verified date: June 2017
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Drug Dependence
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Recovery Line

Locations

Country	Name	City	State
United States	MRU, APT Foundation, Inc	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	APT Foundation, Inc., National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	patient satisfaction	a semi-structured interview will be used to assess overall satisfaction with methadone services and satisfaction ratings of specific components of treatment	6 months
Other	type and amount of health and psychosocial services	the Treatment Services Review is a semistructured used to collect detailed information on receipt of health and psychosocial services outside of the study	6 months
Primary	urine screens	bi-weekly urine screens negative for illicit drugs	6 months
Primary	self reported drug use	monthly days of self reported illicit drug abstinence	6 months
Secondary	treatment retention	days retained in methadone treatment	6 months
Secondary	coping behaviors	coping behaviors as measured by the Effectiveness of Coping Behavior Inventory and the Drug Risk Response Test	6 months