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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01131520
Other study ID # 08-08-173
Secondary ID R01DA026003
Status Completed
Phase N/A
First received May 21, 2010
Last updated November 15, 2017
Start date June 2010
Est. completion date July 2015

Study information

Verified date November 2017
Source Friends Research Institute, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Drug use is a significant cause of morbidity and mortality in the United States. Efforts to develop and rigorously evaluate methods to provide Screening, Brief Intervention and Referral to Treatment (SBIRT) for drug users are needed. Computerized screening and brief interventions in particular have the potential to circumvent some of the potential problems of integrating SBIRT delivered by a counselor into busy primary care settings. These interventions may reduce drug use among individuals who are using drugs but are not yet drug dependent.


Recruitment information / eligibility

Status Completed
Enrollment 360
Est. completion date July 2015
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years or older

- Moderate risk category on the ASSIST scores

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Friends Research Institute Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Friends Research Institute, Inc. National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Human Immunodeficiency Virus (HIV) Drug Use Risk Assessment Battery Subscale HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk. 3 months post-baseline
Secondary Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score ASSIST's Global Continuum of Illicit Drug Risk Score which ranges from 0 to 308. A higher score is associated with higher risk. 6 month post-baseline
Secondary Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score ASSIST's Global Continuum of Illicit Drug Risk Score which ranges from 0 to 308. A higher score is associated with higher risk. 12 months post-baseline
Secondary Hair Testing The predicted probabilities for testing positive on Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and tetrahydrocannabinol (THC), calculated from generalized estimating equations. 6 month post-baseline
Secondary Hair Testing Predicted Probabilities for testing positive on the Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and THC, calculated from generalized estimating equations. 12 month post-baseline
Secondary Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk. 6 month post-baseline
Secondary Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale Score HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk. 12 month post-baseline
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