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Enhancing Early-Phase Care for Primary Care Patients With Unhealthy Substance Use

Primary Purpose

Substance Use Disorders

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

incentives

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring substance use disorders, substance abuse, substance abuse treatment, contingency management

Eligibility Criteria

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

Inclusion Criteria:

Positive self-report alcohol or drug use screen in primary care
Diagnosis of substance use disorder
age 18 or older

Exclusion Criteria:

SUD treatment in past 60 days
cognitive impairment

Sites / Locations

Edith Nourse VA Medical Center (Bedford VA)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Incentives

Arm Description

Prize-based financial incentives, informed by contingency management principles, are offered to patients who attend treatment visits.

Outcomes

Primary Outcome Measures

Initiation

Had initial outpatient treatment visit following positive screen and confirmatory diagnosis

Engagement

Had two additional outpatient treatment visits after initiating treatment

Secondary Outcome Measures

Full Information

NCT ID

NCT01887665

First Posted

June 25, 2013

Last Updated

March 2, 2016

Sponsor

Brandeis University

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT01887665

Brief Title

Enhancing Early-Phase Care for Primary Care Patients With Unhealthy Substance Use

Official Title

Enhancing Early-Phase Care for Primary Care Patients With Unhealthy Substance Use

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brandeis University

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The clinical trial portion of this study tests the hypothesis that contingency management-based incentives for primary care patients with substance use disorders to attend treatment services will increase treatment initiation and engagement. The investigators are investigating whether this approach that has been found effective in specialty treatment settings will work in the primary care context, in conjunction with screening.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Substance Use Disorders

Keywords

substance use disorders, substance abuse, substance abuse treatment, contingency management

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Incentives

Arm Type

Experimental

Arm Description

Prize-based financial incentives, informed by contingency management principles, are offered to patients who attend treatment visits.

Intervention Type

Behavioral

Intervention Name(s)

incentives

Intervention Description

A structured system of prize-based financial incentives rewards attendance at treatment visits.

Primary Outcome Measure Information:

Title

Initiation

Description

Had initial outpatient treatment visit following positive screen and confirmatory diagnosis

Time Frame

90 days

Title

Engagement

Description

Had two additional outpatient treatment visits after initiating treatment

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Positive self-report alcohol or drug use screen in primary care Diagnosis of substance use disorder age 18 or older Exclusion Criteria: SUD treatment in past 60 days cognitive impairment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elizabeth L. Merrick, Ph.D.

Organizational Affiliation

Brandeis University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Edith Nourse VA Medical Center (Bedford VA)

City

Bedford

State/Province

Massachusetts

ZIP/Postal Code

01730

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Enhancing Early-Phase Care for Primary Care Patients With Unhealthy Substance Use

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