Enhancing Early-Phase Care for Primary Care Patients With... | NCT01887665

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

NCT01887665

Sponsor

Brandeis University

Status

Completed

Last Update Posted

Mar 3, 2016Estimated

Enrollment

13Actual

Phase

Not Applicable

Conditions

Substance Use Disorders

Interventions

incentives

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R21DA032039-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Dec 2015Actual

Completion Date

Mar 2016Actual

First Submitted Date

Jun 25, 2013

First Submission Date that Met QC Criteria

Jun 26, 2013

First Posted Date

Jun 27, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2016

Last Update Posted Date

Mar 3, 2016Estimated

Name	Class
National Institute on Drug Abuse (NIDA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Incentives	Experimental	Prize-based financial incentives, informed by contingency management principles, are offered to patients who attend treatment visits.	Behavioral: incentives

Interventions

Name	Type	Description	Arm Group Labels	Other Names
incentives	Behavioral	A structured system of prize-based financial incentives rewards attendance at treatment visits.	Incentives

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Initiation	Had initial outpatient treatment visit following positive screen and confirmatory diagnosis	90 days
Engagement	Had two additional outpatient treatment visits after initiating treatment	90 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elizabeth L. Merrick, Ph.D.	Brandeis University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Edith Nourse VA Medical Center (Bedford VA)		Bedford	Massachusetts	01730	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019966	Substance-Related Disorders

Ancestor Terms

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005298	Fertility

Ancestor Terms

ID	Term
D055703	Reproductive Physiological Phenomena
D012101	Reproductive and Urinary Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided