Trial Outcomes & Findings for Screening Brief Intervention Referral to Treatment (SBIRT) in New Mexico (NCT NCT01131520)

NCT ID: NCT01131520

Last Updated: 2017-12-12

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 360 participants
• Primary outcome timeframe: 3 months post-baseline
• Results posted on: 2017-12-12

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	180	180
Overall Study COMPLETED	179	176
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Measure	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.	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.
Overall Study Computer problem	1	0
Overall Study Counselor not available	0	3
Overall Study Subject changed history after enrollment	0	1

Baseline Characteristics

Screening Brief Intervention Referral to Treatment (SBIRT) in New Mexico

Baseline characteristics by cohort

Measure	Computerized Brief Intervention n=180 Participants 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.	Counselor Delivered Brief Intervention n=179 Participants 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.	Total n=359 Participants Total of all reporting groups
Age, Continuous	36.5 years STANDARD_DEVIATION 14.7 • n=93 Participants	35.7 years STANDARD_DEVIATION 14.6 • n=4 Participants	36.1 years STANDARD_DEVIATION 14.6 • n=27 Participants
Sex: Female, Male Female	83 Participants n=93 Participants	82 Participants n=4 Participants	165 Participants n=27 Participants
Sex: Female, Male Male	97 Participants n=93 Participants	97 Participants n=4 Participants	194 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	83 Participants n=93 Participants	85 Participants n=4 Participants	168 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	97 Participants n=93 Participants	94 Participants n=4 Participants	191 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	6 Participants n=93 Participants	6 Participants n=4 Participants	12 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) White	162 Participants n=93 Participants	161 Participants n=4 Participants	323 Participants n=27 Participants
Race (NIH/OMB) More than one race	8 Participants n=93 Participants	9 Participants n=4 Participants	17 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	180 Participants n=93 Participants	179 Participants n=4 Participants	359 Participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Computerized Brief Intervention n=180 Participants 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.	Counselor Delivered Brief Intervention n=179 Participants 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.
Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score	27.8 units on a scale Standard Error 0.93	29.6 units on a scale Standard Error 0.93

PRIMARY outcome

Timeframe: 3 month post-baseline

Population: 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.

The number of participants testing positive on Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and tetrahydrocannabinol (THC)

Outcome measures

Measure	Computerized Brief Intervention n=159 Participants 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.	Counselor Delivered Brief Intervention n=155 Participants 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.
Hair Testing	93 Participants	100 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Computerized Brief Intervention n=180 Participants 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.	Counselor Delivered Brief Intervention n=179 Participants 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.
Human Immunodeficiency Virus (HIV) Drug Use Risk Assessment Battery Subscale	.06 units on a scale Standard Error .03	.01 units on a scale Standard Error .03

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Computerized Brief Intervention n=180 Participants 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.	Counselor Delivered Brief Intervention n=179 Participants 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.
Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score	27.3 units on a scale Standard Error 1.30	27.4 units on a scale Standard Error 1.33

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Computerized Brief Intervention n=180 Participants 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.	Counselor Delivered Brief Intervention n=179 Participants 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.
Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score	26.5 units on a scale Standard Error 1.32	25.9 units on a scale Standard Error 1.34

SECONDARY outcome

Timeframe: 6 month post-baseline

Population: The sample includes participants who provided usable hair testing data at baseline.

The predicted probabilities for testing positive on Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and tetrahydrocannabinol (THC), calculated from generalized estimating equations.

Outcome measures

Measure	Computerized Brief Intervention n=159 Participants 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.	Counselor Delivered Brief Intervention n=155 Participants 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.
Hair Testing	.59 predicted probability of positive test Standard Error .04	.67 predicted probability of positive test Standard Error .04

SECONDARY outcome

Timeframe: 12 month post-baseline

Population: The sample includes participants who provided usable hair testing data at baseline

Predicted Probabilities for testing positive on the Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and THC, calculated from generalized estimating equations.

Outcome measures

Measure	Computerized Brief Intervention n=159 Participants 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.	Counselor Delivered Brief Intervention n=155 Participants 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.
Hair Testing	.57 predicted probability of positive test Standard Error .04	.59 predicted probability of positive test Standard Error .04

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Computerized Brief Intervention n=180 Participants 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.	Counselor Delivered Brief Intervention n=179 Participants 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.
Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale	.02 units on a scale Standard Error .03	.04 units on a scale Standard Error .03

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Computerized Brief Intervention n=180 Participants 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.	Counselor Delivered Brief Intervention n=179 Participants 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.
Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale Score	.05 units on a scale Standard Error .03	.01 units on a scale Standard Error .04

Adverse Events

Computerized Brief Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Counselor Delivered Brief Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert Schwartz

Friends Research Institute

Phone: 410-837-3977

Email: rschwartz@friendsresearch.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place