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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Computerized Brief Intervention
Computerized one-session brief intervention for drug use
Behavioral: Computerized brief intervention
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
Behavioral: Counselor delivered brief intervention
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Friends Research Institute, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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