Drug Abuse
Conditions
Keywords
brief intervention, computerized brief intervention
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALComputerized Brief Intervention
No additional information needed.
Sponsors
Friends Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* (1) minimum 18 years of age * (2) primary care or dental patients at the participating clinics * (3) score between 4 and 26 (moderate-risk) for illicit drug and/or nonmedical use of prescription drugs on any of the single item drug use risk scores of the ASSIST.
Exclusion criteria
* (1) score in the high-risk range on the ASSIST for any drug (except tobacco) or alcohol use (i.e., ASSIST score \> 26) * (2) no reported drug use within the past 3 months * (3) drug abuse treatment within the past 12 months * (4) a BI at the clinic with the behavioral health counselor within the past month * (5) prior enrollment in the parent study; * (6) plans to move out of New Mexico in the next 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score | 3 month follow-up | The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score | 6-month follow-up | The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Testing Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids. | 3-month | Radioimmunoassay (RIA) Tests were used. |
| Number of Subjects Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids | 6-month follow-up | Radioimmunoassay Testing (RIA) was conducted |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| 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. | 40 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 5 |
Baseline characteristics
| Characteristic | Computerized Brief Intervention | Total | Delayed Computerized Brief Intervention |
|---|---|---|---|
| Age, Continuous | 34.3 years STANDARD_DEVIATION 12.4 | 35.2 years STANDARD_DEVIATION 13 | 36.0 years STANDARD_DEVIATION 13.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 34 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 46 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 33 Participants | 69 Participants | 36 Participants |
| Region of Enrollment United States | 40 participants | 80 participants | 40 participants |
| Sex: Female, Male Female | 25 Participants | 42 Participants | 17 Participants |
| Sex: Female, Male Male | 15 Participants | 38 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
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.
Time frame: 3 month follow-up
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Computerized Brief Intervention | Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score | 24.4 units on a scale | Standard Error 2.2 |
| Delayed Computerized Brief Intervention | Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score | 27.8 units on a scale | Standard Error 2.2 |
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.
Time frame: 6-month follow-up
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Computerized Brief Intervention | Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score | 26.4 units on a scale | Standard Error 2.2 |
| Delayed Computerized Brief Intervention | Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score | 27.1 units on a scale | Standard Error 2.2 |
Other Pre-specified
Number of Subjects Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids
Radioimmunoassay Testing (RIA) was conducted
Time frame: 6-month follow-up
Population: Hair samples were missing due to refusal, insufficient quantity, and missing follow-up interview.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Computerized Brief Intervention | Number of Subjects Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids | 14 Participants |
| Delayed Computerized Brief Intervention | Number of Subjects Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids | 8 Participants |
Other Pre-specified
Number of Subjects Testing Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids.
Radioimmunoassay (RIA) Tests were used.
Time frame: 3-month
Population: Hair samples were missing due to refusal, insufficient quantity, and missing follow-up interview.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Computerized Brief Intervention | Number of Subjects Testing Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids. | 13 Participants |
| Delayed Computerized Brief Intervention | Number of Subjects Testing Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids. | 6 Participants |