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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01131520
First Posted: May 27, 2010
Last Update Posted: November 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Friends Research Institute, Inc.
Results First Submitted: December 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Drug Abuse
HIV Risk Behavior
Interventions: Behavioral: Computerized brief intervention
Behavioral: Counselor delivered brief intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Computerized Brief Intervention   Counselor Delivered Brief Intervention
STARTED   180   180 
COMPLETED   179   176 
NOT COMPLETED   1   4 
Computer problem                1                0 
Counselor not available                0                3 
Subject changed history after enrollment                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   Computerized Brief Intervention   Counselor Delivered Brief Intervention   Total 
Overall Participants Analyzed 
[Units: Participants]
 180   179   359 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.5  (14.7)   35.7  (14.6)   36.1  (14.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      83  46.1%      82  45.8%      165  46.0% 
Male      97  53.9%      97  54.2%      194  54.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      83  46.1%      85  47.5%      168  46.8% 
Not Hispanic or Latino      97  53.9%      94  52.5%      191  53.2% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      6   3.3%      6   3.4%      12   3.3% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      1   0.6%      2   1.1%      3   0.8% 
Black or African American      3   1.7%      1   0.6%      4   1.1% 
White      162  90.0%      161  89.9%      323  90.0% 
More than one race      8   4.4%      9   5.0%      17   4.7% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   180   179   359 


  Outcome Measures
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1.  Primary:   Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score   [ Time Frame: 3 months post-baseline ]

2.  Primary:   Hair Testing   [ Time Frame: 3 month post-baseline ]

3.  Secondary:   Human Immunodeficiency Virus (HIV) Drug Use Risk Assessment Battery Subscale   [ Time Frame: 3 months post-baseline ]

4.  Secondary:   Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score   [ Time Frame: 6 month post-baseline ]

5.  Secondary:   Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score   [ Time Frame: 12 months post-baseline ]

6.  Secondary:   Hair Testing   [ Time Frame: 6 month post-baseline ]

7.  Secondary:   Hair Testing   [ Time Frame: 12 month post-baseline ]

8.  Secondary:   Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale   [ Time Frame: 6 month post-baseline ]

9.  Secondary:   Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale Score   [ Time Frame: 12 month post-baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Robert Schwartz
Organization: Friends Research Institute
phone: 410-837-3977
e-mail: rschwartz@friendsresearch.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01131520     History of Changes
Other Study ID Numbers: 08-08-173
R01DA026003 ( U.S. NIH Grant/Contract )
First Submitted: May 21, 2010
First Posted: May 27, 2010
Results First Submitted: December 20, 2016
Results First Posted: August 21, 2017
Last Update Posted: November 10, 2017