NCT01887665

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

Enrollment Period

2.3 years

First QC Date

June 25, 2013

Last Update Submit

March 2, 2016

Conditions

Substance Use Disorders

Keywords

substance use disorderssubstance abusesubstance abuse treatmentcontingency management

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Incentives

EXPERIMENTAL

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

Behavioral: incentives

Interventions

incentivesBEHAVIORAL

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

Incentives

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • SUD treatment in past 60 days
  • cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edith Nourse VA Medical Center (Bedford VA)

Bedford, Massachusetts, 01730, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Fertility

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Elizabeth L. Merrick, Ph.D.

    Brandeis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

June 25, 2013

First Posted

June 27, 2013

Study Start

August 1, 2013

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

March 3, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)