- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01131520
Screening Brief Intervention Referral to Treatment (SBIRT) in New Mexico
November 15, 2017 updated by: Friends Research Institute, Inc.
SBIRT in New Mexico
The purpose of this study is to compare the effectiveness in reducing drug use and its associated problems of a brief intervention for drug use delivered by a behavioral health counselor as compared to a brief intervention delivered by a computerized intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Drug use is a significant cause of morbidity and mortality in the United States.
Efforts to develop and rigorously evaluate methods to provide Screening, Brief Intervention and Referral to Treatment (SBIRT) for drug users are needed.
Computerized screening and brief interventions in particular have the potential to circumvent some of the potential problems of integrating SBIRT delivered by a counselor into busy primary care settings.
These interventions may reduce drug use among individuals who are using drugs but are not yet drug dependent.
Study Type
Interventional
Enrollment (Actual)
360
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
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Friends Research Institute
-
-
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:
- 18 years or older
- Moderate risk category on the ASSIST scores
Exclusion Criteria:
- planning to move out of New Mexico in the next year
- receipt of formal drug abuse treatment or a brief intervention for drug use in the past month.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Computerized Brief Intervention
Computerized one-session brief intervention for drug use
|
This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting.
The intervention is delivered in one session.
|
Active Comparator: Counselor delivered brief intervention
This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing
|
This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score
Time Frame: 3 months post-baseline
|
The ASSIST's Global Continuum of Illicit Drug Risk was used.
A higher score is considered more severe risk.
The scores range from 0 to 308.
|
3 months post-baseline
|
Hair Testing
Time Frame: 3 month post-baseline
|
The number of participants testing positive on Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and tetrahydrocannabinol (THC)
|
3 month post-baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Human Immunodeficiency Virus (HIV) Drug Use Risk Assessment Battery Subscale
Time Frame: 3 months post-baseline
|
HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22.
A higher score is considered to be associated with higher risk.
|
3 months post-baseline
|
Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score
Time Frame: 6 month post-baseline
|
ASSIST's Global Continuum of Illicit Drug Risk Score which ranges from 0 to 308.
A higher score is associated with higher risk.
|
6 month post-baseline
|
Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score
Time Frame: 12 months post-baseline
|
ASSIST's Global Continuum of Illicit Drug Risk Score which ranges from 0 to 308.
A higher score is associated with higher risk.
|
12 months post-baseline
|
Hair Testing
Time Frame: 6 month post-baseline
|
The predicted probabilities for testing positive on Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and tetrahydrocannabinol (THC), calculated from generalized estimating equations.
|
6 month post-baseline
|
Hair Testing
Time Frame: 12 month post-baseline
|
Predicted Probabilities for testing positive on the Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and THC, calculated from generalized estimating equations.
|
12 month post-baseline
|
Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale
Time Frame: 6 month post-baseline
|
HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22.
A higher score is considered to be associated with higher risk.
|
6 month post-baseline
|
Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale Score
Time Frame: 12 month post-baseline
|
HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22.
A higher score is considered to be associated with higher risk.
|
12 month post-baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert P Schwartz, M.D., Friends Research Institute, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gryczynski J, Carswell SB, O'Grady KE, Mitchell SG, Schwartz RP. Gender and ethnic differences in primary care patients' response to computerized vs. in-person brief intervention for illicit drug misuse. J Subst Abuse Treat. 2018 Jan;84:50-56. doi: 10.1016/j.jsat.2017.10.009. Epub 2017 Nov 7.
- Mitchell SG, Monico LB, Gryczynski J, O'Grady KE, Schwartz RP. Staff Views of Acceptability and Appropriateness of a Computer-Delivered Brief Intervention for Moderate Drug and Alcohol Use. J Psychoactive Drugs. 2015 Sep-Oct;47(4):301-7. doi: 10.1080/02791072.2015.1075631. Epub 2015 Sep 16.
- Gryczynski J, Mitchell SG, Ondersma SJ, O'Grady KE, Schwartz RP. Potential radiating effects of misusing substances among medical patients receiving brief intervention. J Subst Abuse Treat. 2015 Aug;55:39-44. doi: 10.1016/j.jsat.2015.02.003. Epub 2015 Feb 23.
- Gryczynski J, Mitchell SG, Gonzales A, Moseley A, Peterson TR, Ondersma SJ, O'Grady KE, Schwartz RP. A randomized trial of computerized vs. in-person brief intervention for illicit drug use in primary care: outcomes through 12 months. J Subst Abuse Treat. 2015 Mar;50:3-10. doi: 10.1016/j.jsat.2014.09.002. Epub 2014 Sep 16.
- Schwartz RP, Gryczynski J, Mitchell SG, Gonzales A, Moseley A, Peterson TR, Ondersma SJ, O'Grady KE. Computerized versus in-person brief intervention for drug misuse: a randomized clinical trial. Addiction. 2014 Jul;109(7):1091-8. doi: 10.1111/add.12502. Epub 2014 Mar 10.
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
June 1, 2010
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
May 21, 2010
First Submitted That Met QC Criteria
May 25, 2010
First Posted (Estimate)
May 27, 2010
Study Record Updates
Last Update Posted (Actual)
December 12, 2017
Last Update Submitted That Met QC Criteria
November 15, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-08-173
- R01DA026003 (U.S. NIH Grant/Contract)
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.
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