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Screening Brief Intervention Referral to Treatment (SBIRT) in New Mexico

Primary Purpose

Drug Abuse, HIV Risk Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized brief intervention
Counselor delivered brief intervention
Sponsored by
Friends Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Abuse focused on measuring SBIRT, Drug abuse

Eligibility Criteria

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

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.

Sites / Locations

  • Friends Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Computerized Brief Intervention

Counselor delivered brief intervention

Arm Description

Computerized one-session brief intervention for drug use

This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing

Outcomes

Primary Outcome Measures

Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score
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.
Hair Testing
The number of participants testing positive on Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and tetrahydrocannabinol (THC)

Secondary Outcome Measures

Human Immunodeficiency Virus (HIV) Drug Use Risk Assessment Battery Subscale
HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.
Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score
ASSIST's Global Continuum of Illicit Drug Risk Score which ranges from 0 to 308. A higher score is associated with higher risk.
Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score
ASSIST's Global Continuum of Illicit Drug Risk Score which ranges from 0 to 308. A higher score is associated with higher risk.
Hair Testing
The predicted probabilities for testing positive on Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and tetrahydrocannabinol (THC), calculated from generalized estimating equations.
Hair Testing
Predicted Probabilities for testing positive on the Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and THC, calculated from generalized estimating equations.
Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale
HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.
Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale Score
HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.

Full Information

First Posted
May 21, 2010
Last Updated
November 15, 2017
Sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01131520
Brief Title
Screening Brief Intervention Referral to Treatment (SBIRT) in New Mexico
Official Title
SBIRT in New Mexico
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Abuse, HIV Risk Behavior
Keywords
SBIRT, Drug abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computerized Brief Intervention
Arm Type
Experimental
Arm Description
Computerized one-session brief intervention for drug use
Arm Title
Counselor delivered brief intervention
Arm Type
Active Comparator
Arm Description
This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing
Intervention Type
Behavioral
Intervention Name(s)
Computerized brief intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Counselor delivered brief intervention
Intervention Description
This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing.
Primary Outcome Measure Information:
Title
Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score
Description
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.
Time Frame
3 months post-baseline
Title
Hair Testing
Description
The number of participants testing positive on Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and tetrahydrocannabinol (THC)
Time Frame
3 month post-baseline
Secondary Outcome Measure Information:
Title
Human Immunodeficiency Virus (HIV) Drug Use Risk Assessment Battery Subscale
Description
HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.
Time Frame
3 months post-baseline
Title
Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score
Description
ASSIST's Global Continuum of Illicit Drug Risk Score which ranges from 0 to 308. A higher score is associated with higher risk.
Time Frame
6 month post-baseline
Title
Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score
Description
ASSIST's Global Continuum of Illicit Drug Risk Score which ranges from 0 to 308. A higher score is associated with higher risk.
Time Frame
12 months post-baseline
Title
Hair Testing
Description
The predicted probabilities for testing positive on Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and tetrahydrocannabinol (THC), calculated from generalized estimating equations.
Time Frame
6 month post-baseline
Title
Hair Testing
Description
Predicted Probabilities for testing positive on the Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and THC, calculated from generalized estimating equations.
Time Frame
12 month post-baseline
Title
Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale
Description
HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.
Time Frame
6 month post-baseline
Title
Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale Score
Description
HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.
Time Frame
12 month post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert P Schwartz, M.D.
Organizational Affiliation
Friends Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friends Research Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29195593
Citation
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.
Results Reference
derived
PubMed Identifier
26375411
Citation
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.
Results Reference
derived
PubMed Identifier
25812927
Citation
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.
Results Reference
derived
PubMed Identifier
25282578
Citation
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.
Results Reference
derived
PubMed Identifier
24520906
Citation
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.
Results Reference
derived

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Screening Brief Intervention Referral to Treatment (SBIRT) in New Mexico

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