- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01887665
Enhancing Early-Phase Care for Primary Care Patients With Unhealthy Substance Use
March 2, 2016 updated by: Elizabeth Merrick, Brandeis University
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Bedford, Massachusetts, United States, 01730
- Edith Nourse VA Medical Center (Bedford VA)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Incentives
Prize-based financial incentives, informed by contingency management principles, are offered to patients who attend treatment visits.
|
A structured system of prize-based financial incentives rewards attendance at treatment visits.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Initiation
Time Frame: 90 days
|
Had initial outpatient treatment visit following positive screen and confirmatory diagnosis
|
90 days
|
|
Engagement
Time Frame: 90 days
|
Had two additional outpatient treatment visits after initiating treatment
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth L. Merrick, Ph.D., Brandeis University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
June 25, 2013
First Submitted That Met QC Criteria
June 26, 2013
First Posted (Estimate)
June 27, 2013
Study Record Updates
Last Update Posted (Estimate)
March 3, 2016
Last Update Submitted That Met QC Criteria
March 2, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12116
- 1R21DA032039-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.