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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA026003 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computerized Brief Intervention | Experimental | Computerized one-session brief intervention for drug use |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized brief intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months post-baseline |
| Hair Testing | The number of participants testing positive on Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and tetrahydrocannabinol (THC) | 3 month post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months post-baseline |
| Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert P Schwartz, M.D. | Friends Research Institute, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Friends Research Institute | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29195593 | Derived | 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. | |
| 26375411 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Computerized Brief Intervention | Computerized one-session brief intervention for drug use 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. |
| FG001 | Counselor Delivered Brief Intervention | This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Computerized Brief Intervention | Computerized one-session brief intervention for drug use 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 3 months post-baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Computerized Brief Intervention | Computerized one-session brief intervention for drug use 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Schwartz | Friends Research Institute | 410-837-3977 | rschwartz@friendsresearch.org |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Counselor delivered brief intervention | Behavioral | This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing. |
|
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 | 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 | 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 | 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 | 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 | 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 |
| 25812927 | Derived | 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. |
| 25282578 | Derived | 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. |
| 24520906 | Derived | 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. |
| Subject changed history after enrollment |
|
| Counselor Delivered Brief Intervention |
This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Hair Testing | The number of participants testing positive on Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and tetrahydrocannabinol (THC) | The number of participants of the total sample who agreed to provide an analyzable hair specimen. Hair testing was not available for subjects not interviewed, those who refused testing, or who were unable to provide a sufficient quantity of hair for testing. | Posted | Count of Participants | Participants | 3 month post-baseline |
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 3 months post-baseline |
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 6 month post-baseline |
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 12 months post-baseline |
|
|
|
| Secondary | 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. | The sample includes participants who provided usable hair testing data at baseline. | Posted | Least Squares Mean | Standard Error | predicted probability of positive test | 6 month post-baseline |
|
|
|
| Secondary | Hair Testing | Predicted Probabilities for testing positive on the Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and THC, calculated from generalized estimating equations. | The sample includes participants who provided usable hair testing data at baseline | Posted | Least Squares Mean | Standard Error | predicted probability of positive test | 12 month post-baseline |
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 6 month post-baseline |
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 12 month post-baseline |
|
|
|
| 0 |
| 180 |
| 0 |
| 180 |
| EG001 | Counselor Delivered Brief Intervention | This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing. | 0 | 179 | 0 | 179 |
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