NCT01131520

Brief Summary

The purpose of this study is to compare the effectiveness in reducing drug use and its associated problems of a brief intervention for drug use delivered by a behavioral health counselor as compared to a brief intervention delivered by a computerized intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 27, 2010

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

August 21, 2017

Completed
Last Updated

December 12, 2017

Status Verified

November 1, 2017

Enrollment Period

2.5 years

First QC Date

May 21, 2010

Results QC Date

December 20, 2016

Last Update Submit

November 15, 2017

Conditions

Keywords

SBIRTDrug abuse

Outcome Measures

Primary Outcomes (2)

  • Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score

    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.

    3 months post-baseline

  • Hair Testing

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

    3 month post-baseline

Secondary Outcomes (7)

  • Human Immunodeficiency Virus (HIV) Drug Use Risk Assessment Battery Subscale

    3 months post-baseline

  • Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score

    6 month post-baseline

  • Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score

    12 months post-baseline

  • Hair Testing

    6 month post-baseline

  • Hair Testing

    12 month post-baseline

  • +2 more secondary outcomes

Study Arms (2)

Computerized Brief Intervention

EXPERIMENTAL

Computerized one-session brief intervention for drug use

Behavioral: Computerized brief intervention

Counselor delivered brief intervention

ACTIVE COMPARATOR

This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing

Behavioral: Counselor delivered brief intervention

Interventions

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.

Computerized Brief Intervention

This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing.

Counselor delivered brief intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Moderate risk category on the ASSIST scores

You may not qualify if:

  • planning to move out of New Mexico in the next year
  • receipt of formal drug abuse treatment or a brief intervention for drug use in the past month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Friends Research Institute

Baltimore, Maryland, 21201, United States

Location

Related Publications (5)

  • Gryczynski J, Carswell SB, O'Grady KE, Mitchell SG, Schwartz RP. Gender and ethnic differences in primary care patients' response to computerized vs. in-person brief intervention for illicit drug misuse. J Subst Abuse Treat. 2018 Jan;84:50-56. doi: 10.1016/j.jsat.2017.10.009. Epub 2017 Nov 7.

  • Mitchell SG, Monico LB, Gryczynski J, O'Grady KE, Schwartz RP. Staff Views of Acceptability and Appropriateness of a Computer-Delivered Brief Intervention for Moderate Drug and Alcohol Use. J Psychoactive Drugs. 2015 Sep-Oct;47(4):301-7. doi: 10.1080/02791072.2015.1075631. Epub 2015 Sep 16.

  • Gryczynski J, Mitchell SG, Ondersma SJ, O'Grady KE, Schwartz RP. Potential radiating effects of misusing substances among medical patients receiving brief intervention. J Subst Abuse Treat. 2015 Aug;55:39-44. doi: 10.1016/j.jsat.2015.02.003. Epub 2015 Feb 23.

  • Gryczynski J, Mitchell SG, Gonzales A, Moseley A, Peterson TR, Ondersma SJ, O'Grady KE, Schwartz RP. A randomized trial of computerized vs. in-person brief intervention for illicit drug use in primary care: outcomes through 12 months. J Subst Abuse Treat. 2015 Mar;50:3-10. doi: 10.1016/j.jsat.2014.09.002. Epub 2014 Sep 16.

  • Schwartz RP, Gryczynski J, Mitchell SG, Gonzales A, Moseley A, Peterson TR, Ondersma SJ, O'Grady KE. Computerized versus in-person brief intervention for drug misuse: a randomized clinical trial. Addiction. 2014 Jul;109(7):1091-8. doi: 10.1111/add.12502. Epub 2014 Mar 10.

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Robert Schwartz
Organization
Friends Research Institute

Study Officials

  • Robert P Schwartz, M.D.

    Friends Research Institute, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2010

First Posted

May 27, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2012

Study Completion

July 1, 2015

Last Updated

December 12, 2017

Results First Posted

August 21, 2017

Record last verified: 2017-11

Locations