NCT03057119

Feasibility of SBIRT-PN

Completed NA Results posted Last updated 11 September 2023

What this trial tests

NA trial testing Psycho-educational content (5 Minutes) in Substance Use in 86 participants. Completed in 31 March 2022.

Timeline

12 February 2018

Primary endpoint
28 February 2021

31 March 2022

Quick facts

Lead sponsor	Florida State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	screening
Enrollment	86
Start date	12 February 2018
Primary completion	28 February 2021
Estimated completion	31 March 2022
Sites	3 locations across United States

Drugs / interventions tested

• Psycho-educational content (5 Minutes)
• Readiness Assessment (10 minutes)
• Goal-Setting (5 minutes)
• Identifying and prioritizing needs (5 minutes)
• Explanation of Peer Navigator and Session wrap (5 minutes)

Conditions studied

• Substance Use — all drugs for Substance Use →
• HIV/AIDS — all drugs for HIV/AIDS →
• Older Adults — all drugs for Older Adults →
• Behavioral Intervention — all drugs for Behavioral Intervention →

Sponsor

Florida State University

Who can join

Adults 18 to 85, any sex, with Substance Use or HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Ranking Intervention as Acceptable Primary · 30 Days

To examine ratings of acceptability, the investigators will use the overall acceptability score and percentage of acceptability. Overall acceptability will be assessed by summing ratings from the 10-item questionnaire to provide a total intervention acceptability score for the intervention, such that acceptability scores for the intervention could range from 10 (low acceptability) to 50 (high acceptability). The intervention will be considered to have acceptability if 80% of the participants rank the intervention as acceptable (i.e., 4 or higher) on 80% or more of the scale items. The investig

Group	Value	95% CI
Phase I: SBIRT Intervention (Pre-COVID-19)	9
Phase I: Treatment as Usual (Pre-COVID-19)	5

Number of Participants Who Obtained Formal Substance Use Treatment Secondary · 6 Months

Participants will self-report if they obtained formal substance use treatment (i.e., any services sought to address substance use from individual therapy to 12 step fellowships). The investigators will request treatment facility information and permission to verify treatment. Once treatment has been verified, treatment engagement will be coded as 0= no formal treatment 1= formal treatment engagement

Group	Value	95% CI
Phase I: SBIRT Intervention (Pre-COVID-19)	1
Phase I: Treatment as Usual (Pre-COVID-19)	1

Number of Participants Who Used Different Types of Substances (Self-Reported) Secondary · 6 Months

A standard measure from the NIDA STTR Vulnerable Populations Data Harmonization tool kit will be used.

Marijuana

Group	Value	95% CI
Phase I: SBIRT Intervention (Pre-COVID-19)	16
Phase I: Treatment as Usual (Pre-COVID-19)	17

Opiates/Opioids

Group	Value	95% CI
Phase I: SBIRT Intervention (Pre-COVID-19)	5
Phase I: Treatment as Usual (Pre-COVID-19)	4

Cocaine

Group	Value	95% CI
Phase I: SBIRT Intervention (Pre-COVID-19)	1
Phase I: Treatment as Usual (Pre-COVID-19)	2

Amphetamines

Group	Value	95% CI
Phase I: SBIRT Intervention (Pre-COVID-19)	0
Phase I: Treatment as Usual (Pre-COVID-19)	1

Methamphetamine

Group	Value	95% CI
Phase I: SBIRT Intervention (Pre-COVID-19)	0
Phase I: Treatment as Usual (Pre-COVID-19)	1

MDMA

Group	Value	95% CI
Phase I: SBIRT Intervention (Pre-COVID-19)	0
Phase I: Treatment as Usual (Pre-COVID-19)	1

Number of Participants Who Used Different Types of Substances (Biologically Confirmed Via Urinalysis) Secondary · 6 Months

A CLIA 12-Panel Instant Drug Test Cup (CLIAwaivedTM, San Diego, CA), which tests for the presence of 12 common substances in the urine will be used.

Marijuana

Group	Value	95% CI
Phase I: SBIRT Intervention (Pre-COVID-19)	16
Phase I: Treatment as Usual (Pre-COVID-19)	17

Buprenorphine

Group	Value	95% CI
Phase I: SBIRT Intervention (Pre-COVID-19)	1
Phase I: Treatment as Usual (Pre-COVID-19)	1

Methadone

Group	Value	95% CI
Phase I: SBIRT Intervention (Pre-COVID-19)	3
Phase I: Treatment as Usual (Pre-COVID-19)	1

Tricyclic Antidepressants

Group	Value	95% CI
Phase I: SBIRT Intervention (Pre-COVID-19)	4
Phase I: Treatment as Usual (Pre-COVID-19)	7

Barbiturates

Group	Value	95% CI
Phase I: SBIRT Intervention (Pre-COVID-19)	0
Phase I: Treatment as Usual (Pre-COVID-19)	0

Benzodiazepines

Group	Value	95% CI
Phase I: SBIRT Intervention (Pre-COVID-19)	4
Phase I: Treatment as Usual (Pre-COVID-19)	2

Oxycodone

Group	Value	95% CI
Phase I: SBIRT Intervention (Pre-COVID-19)	2
Phase I: Treatment as Usual (Pre-COVID-19)	2

Amphetamines

Group	Value	95% CI
Phase I: SBIRT Intervention (Pre-COVID-19)	0
Phase I: Treatment as Usual (Pre-COVID-19)	1

Sponsor's own description

Substance misuse is a common problem among HIV+ individuals. Research suggests that a Screening, Brief Intervention, and Treatment (SBIRT) model can be effective in reducing substance misuse in the general older adult population; however these findings have not been verified in the more vulnerable HIV+ older adult population. The present study seeks to address the problem of substance misuse in older HIV+ adults by piloting a SBIRT model for older HIV+ adults in a in a primary care setting. Individual reductions in alcohol and drug use can have significant effects on public health and safety when observed over a large population at risk for substance use problems. With wider dissemination statewide, a relatively low-cost intervention such as SBIRT could offer demonstrated benefits in this population.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.