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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA026003 | U.S. NIH Grant/Contract | View source |
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The purpose of the study is to determine whether a computerized brief intervention for moderate risk drug use among adult primary care patients is more effective than providing such patients with a substance abuse assessment alone.
The study will enroll 80 adult primary care patients who have moderate risk drug use. Eligible participants (N = 80) will be randomly assigned to immediately receive a computerized brief intervention focused on drug use or to receive the same computerized brief intervention at 3-month follow-up. All participants will be assessed at three time points: baseline, and at 3 and 6 month follow-ups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computerized Brief Intervention | Experimental | Computerized Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use. |
|
| Delayed Computerized Brief Intervention | Other | Participants receive only a substance abuse assessment at baseline. At three-month follow-up, they then receive the computerized brief intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized Brief Intervention | Behavioral | No additional information needed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score | The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk. | 3 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score | The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk. | 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Testing Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids. | Radioimmunoassay (RIA) Tests were used. | 3-month |
| Number of Subjects Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids |
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 |
|---|---|---|---|---|---|---|
| First Choice Community Healthcare | Edgewood | New Mexico | 87015 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Computerized Brief Intervention | Computerized Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use. Computerized Brief Intervention: No additional information needed. |
| FG001 | Delayed Computerized Brief Intervention | Participants receive only a substance abuse assessment at baseline. At three-month follow-up, they then receive the computerized brief intervention. Computerized Brief Intervention: No additional information needed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Computerized Brief Intervention | Computerized Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use. Computerized Brief Intervention: No additional information needed. |
| 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, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score | The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk. | Posted | Least Squares Mean | Standard Error | units on a scale | 3 month follow-up |
|
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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 Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use. Computerized Brief Intervention: No additional information needed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Schwartz, M.D. | Friends Research Institute | 410-837-3977 | 276 | 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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Radioimmunoassay Testing (RIA) was conducted
| 6-month follow-up |
| Delayed Computerized Brief Intervention |
Participants receive only a substance abuse assessment at baseline. At three-month follow-up, they then receive the computerized brief intervention. Computerized Brief Intervention: No additional information needed. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score | The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk. | Posted | Least Squares Mean | Standard Error | units on a scale | 6-month follow-up |
|
|
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| Other Pre-specified | Number of Subjects Testing Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids. | Radioimmunoassay (RIA) Tests were used. | Hair samples were missing due to refusal, insufficient quantity, and missing follow-up interview. | Posted | Count of Participants | Participants | 3-month |
|
|
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| Other Pre-specified | Number of Subjects Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids | Radioimmunoassay Testing (RIA) was conducted | Hair samples were missing due to refusal, insufficient quantity, and missing follow-up interview. | Posted | Count of Participants | Participants | 6-month follow-up |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Delayed Computerized Brief Intervention | Participants receive only a substance abuse assessment at baseline. At three-month follow-up, they then receive the computerized brief intervention. Computerized Brief Intervention: No additional information needed. | 0 | 40 | 0 | 40 |
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