Study of Computer-Based Treatment for Drug Dependence

NCT01315184 | Completed Phase 2 DMC

• 2 other identifiers: 0804003684K01DA022398-01A2
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the whether an automated telephone-based system is useful and helpful for opioid dependent patients receiving buprenorphine in primary care. The Recovery Line support system is a Therapeutic Interactive Voice Response system based on cognitive behavioral therapy (CBT). The Recovery Line support system includes a variety of modules presenting the basic principles and strategies of CBT. Each module includes learning sections and activities sections to provide direct guidance in using skills. The Recovery Line support system is interactive and also includes a questionnaire to help patients identify problems and recommend modules for use, as well as an inspiration section, an introduction, and an immediate assistance menu. Following development of an initial system the current trial will recruit 40 patients receiving buprenorphine maintenance from a physician provider in the local community. Patients will be randomly (flip of a coin) to receive the Recover Line Support system or to treatment as usual with their physician. Patients assigned to TIVR will be trained on the system and provided 24-hr access to the TIVR system for a four week period. Primary outcome variables will be how long patients remain in treatment, self-reported abstinence from opioids and other drugs, and abstinence as measured by weekly drug screens. It is expected that patients assigned to TIVR will better treatment outcomes than patients assigned to TAU.

Conditions

Opioid-Related Disorders; Heroin Dependence

Keywords

Interactive Voice Response; Computer-based Treatment; Opioid Agonist; Buprenorphine; Methadone

Outcome Measures

Primary Outcomes (2)

• Opioid Abstinence

  Continuous opioid abstinence as documented by weekly urinalysis

  4 Weeks

• Retention

  Retention in the study

  4 Weeks

Secondary Outcomes (2)

• Self Reported Drug Abstinent

  4 weeks

• system use

  4 weeks

Study Arms (2)

Recovery Line Support System

EXPERIMENTAL

Patients assigned to the Recovery Line Support System will be trained on the system and provided 24-hr access to the system for a four week period, provided with a Recovery notebook, and given reminder calls to contact the system.

Behavioral: Recovery Line Support System

Treatment as Usual

NO INTERVENTION

Patients assigned to the TAU condition will receive any services provided by their buprenorphine provider and any additional services that their provider refers or recommends that patients attend. No additional services will be provided by the study.

Interventions

Recovery Line Support System BEHAVIORAL

Full time access (24 hours/7 days per week) to an automated, telephone-based, interactive, voice response (IVR)system for 4 weeks. The program was developed based on a behavioral theory of substance abuse, and comprises four components: 1) self-assessment 2) learning about skills , 3) activities for current help and skills training, and 4) Feedback.

Recovery Line Support System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are at least 18 years old
• have initiated buprenorphine maintenance treatment from an approved physician in the previous two weeks

You may not qualify if:

• are a current suicide or homicide risk or meet criteria for psychiatric disorder that would interfere with ability to complete study
• are unable to read or understand English
• have a life-threatening or unstable medical problem

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

APT Foundation

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Heroin Dependence

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Brent A. Moore, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: March 15, 2011
• Study Start: July 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2012
• Last Updated: April 2, 2020

Record last verified: 2020-03

Locations

US (1)