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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01683643
Other study ID # R01DA031879
Secondary ID
Status Completed
Phase N/A
First received September 5, 2012
Last updated May 9, 2017
Start date April 2012
Est. completion date March 31, 2017

Study information

Verified date May 2017
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to determine whether SBIRT is an effective intervention with inmates and to estimate the costs of providing SBIRT to this population.


Description:

Screening, Brief Intervention, and Referral to Treatment (SBIRT) is an evidence-based practice that has been found to be effective in reducing alcohol and illicit drug use, mainly among persons recruited in medical centers, primary care offices, emergency rooms, and colleges and universities. But SBIRT has the potential to be applicable to other populations that have, or that are at risk for, substance use problems. In particular, offenders have high prevalence of drug and alcohol use at varying levels of severity and often do not receive adequate intervention, either because of limited availability of programs, low motivation, or lack of awareness of the consequences of their substance use.

The scientific aims of the study are:

1. Assess the effectiveness of SBIRT with offenders in terms of participation in brief intervention (if so indicated) and enrollment in treatment (if so indicated).

2. Assess the effectiveness of SBIRT with offenders in terms of drug use, criminal activity, and criminal justice involvement at 12 months following baseline.

3. Determine whether there are differences in acceptability, participation, and outcomes between men and women.

4. Determine the cost of providing the SBIRT intervention with this population.

The clinical aims of the study are:

1. To complement the use of SBIRT within Los Angeles County's substance abuse treatment system.

2. To expand prevention and treatment options for offenders with substance abuse problems.

To our knowledge, this would be the first rigorous test of SBIRT with an offender population.

We will recruit inmates at two Los Angeles County Sheriff jail facilities, one for men and one for women (25% of total sample), and randomly assign them to the treatment (SBIRT) group (N =400) or to the control (no intervention) group (N = 400). Baseline demographic data will be collected. Subjects in both groups will be screened for substance use risk using The Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) developed by the World Health Organization. Control subjects will receive only their risk score and informational materials regarding the health risks of substance use. Experimental subjects, in addition to their risk score and informational materials, will also receive a brief intervention and a referral to treatment appropriate to their risk score from trained health educators. The health educators will be provided by Homeless Health Care, Los Angeles. Twelve months after study admission, all study participants will be contacted for a follow-up interview. We will obtain records-based data on arrests and jail incarceration over the follow-up period from the Sheriff's Department and the California Department of Justice. We will also collect subject participation in publicly-funded treatment from the Substance Abuse Prevention and Control Division of the Los Angeles County Department of Health.


Recruitment information / eligibility

Status Completed
Enrollment 800
Est. completion date March 31, 2017
Est. primary completion date March 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- The sample for the study will be drawn from an offender population who are within 2-3 weeks of their release from MCJ or CRDF in Los Angeles County. In addition, subjects must be:

- At least 18 years of age

- English or Spanish speaking

- Not subject to extended jail or prison sentence

- Able to provide informed consent to participate in the study

Exclusion Criteria:

- Study exclusion criteria:

- Inability to provide informed consent to study participation because of cognitive impairment.

- Inability to communicate in either English or Spanish

- Refusal to complete Locator form for follow-up.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
SBIRT
Screening, brief intervention, and referral to treatment.
Control Group
Control subjects will receive only their risk score and informational materials regarding the health risks of substance use.

Locations

Country Name City State
United States University of California Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary A reduction in the use of drugs and alcohol 12 months
Secondary Participation in treatment 12 months
Secondary Rearrest and incarceration 12 months
Secondary Quality of life 12 months
Secondary A reduction in HIV risk behaviors 12 months
Secondary The cost benefit of SBIRT for offenders 12 months
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