Drug AbuseNCT01131520
Screening Brief Intervention Referral to Treatment (SBIRT) in New Mexico
A study testing Computerized brief intervention and Counselor delivered brief intervention in people with Drug Abuse and HIV Risk Behavior, run by Friends Research Institute, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Abuse, HIV Risk Behavior
- What is being tested?
- Computerized brief intervention and Counselor delivered brief intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Moderate risk category on the ASSIST scores
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Friends Research Institute
Baltimore, Maryland, 21201
About this study
Official title: 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.
Read the 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.
- Conditions
- Drug Abuse, HIV Risk Behavior
- Being tested
- Computerized brief intervention, Counselor delivered brief intervention
- Keywords
- SBIRT, Drug abuse
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized brief interventionBehavioural
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.
Counselor delivered brief interventionBehavioural
This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing.
| Study group | Role | What they receive |
|---|---|---|
| Computerized Brief Intervention | Experimental | Computerized one-session brief intervention for drug use Receives: Behavioral: Computerized brief intervention |
| Counselor delivered brief intervention | Active comparator | This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing Receives: Behavioral: Counselor delivered brief intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post-baseline
Hair Testing
The number of participants testing positive on Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and tetrahydrocannabinol (THC)
Measured: 3 month post-baseline
Secondary outcomes (7)
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.
Measured: 3 months post-baseline
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.
Measured: 6 month post-baseline
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.
Measured: 12 months post-baseline
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.
Measured: 6 month post-baseline
Hair Testing
Predicted Probabilities for testing positive on the Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and THC, calculated from generalized estimating equations.
Measured: 12 month post-baseline
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.
Measured: 6 month post-baseline
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.
Measured: 12 month post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2012
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Drug AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Friends Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Robert P Schwartz, M.D., Principal investigator, Friends Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131520
- Sponsor's protocol ID
- 08-08-173
- Other IDs
- R01DA026003
- Status last verified
- Nov 2017
- First submitted
- 21 May 2010
- Last updated
- 12 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 29195593Mitchell 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.
PubMed 26375411Gryczynski 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.
PubMed 25812927Gryczynski 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.
PubMed 25282578Schwartz 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.
PubMed 24520906
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SBIRT in New Mexico
- ClinicalTrials.gov ID
- NCT01131520
- Acronym / sponsor ID
- 08-08-173
- Conditions
- Drug Abuse, HIV Risk Behavior
- Keywords
- SBIRT, Drug abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Friends Research Institute, Inc.University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 27 May 2010 (estimated)
- Results
- Posted 21 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computerized Brief Intervention | Experimental | Behavioral: Computerized brief interventionComputerized one-session brief intervention for drug use |
| Counselor delivered brief intervention | Active comparator | Behavioral: Counselor delivered brief interventionThis is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- Moderate risk category on the ASSIST scores
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized brief interventionThis 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. | Behavioural | Computerized Brief Intervention |
| Counselor delivered brief interventionThis is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing. | Behavioural | Counselor delivered brief intervention |
Primary outcome
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.
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)
7 secondary outcomes
Human Immunodeficiency Virus (HIV) Drug Use Risk Assessment Battery Subscale
Time frame: 3 months post-baseline
Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score
Time frame: 6 month post-baseline
Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score
Time frame: 12 months post-baseline
Hair Testing
Time frame: 6 month post-baseline
Hair Testing
Time frame: 12 month post-baseline
Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale
Time frame: 6 month post-baseline
Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale Score
Time frame: 12 month post-baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29195593Gryczynski 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.
- Derived from this study: PubMed 26375411Mitchell 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.
- Derived from this study: PubMed 25812927Gryczynski 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.
- Derived from this study: PubMed 25282578Gryczynski 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.
- Derived from this study: PubMed 24520906Schwartz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert P Schwartz, M.D. principal investigator
Friends Research Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized brief intervention and Counselor delivered brief intervention in people with Drug Abuse and HIV Risk Behavior, run by Friends Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score (time frame: 3 months post-baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01131520, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2017.