- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01936623
Computerized Brief Intervention vs. Delayed Computerized Brief Intervention
April 19, 2017 updated by: Friends Research Institute, Inc.
The purpose of the study is to determine whether a computerized brief intervention for moderate risk drug use among adult primary care patients is more effective than providing such patients with a substance abuse assessment alone.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study will enroll 80 adult primary care patients who have moderate risk drug use.
Eligible participants (N = 80) will be randomly assigned to immediately receive a computerized brief intervention focused on drug use or to receive the same computerized brief intervention at 3-month follow-up.
All participants will be assessed at three time points: baseline, and at 3 and 6 month follow-ups.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Mexico
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Edgewood, New Mexico, United States, 87015
- First Choice Community Healthcare
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- (1) minimum 18 years of age
- (2) primary care or dental patients at the participating clinics
- (3) score between 4 and 26 (moderate-risk) for illicit drug and/or nonmedical use of prescription drugs on any of the single item drug use risk scores of the ASSIST.
Exclusion Criteria:
- (1) score in the high-risk range on the ASSIST for any drug (except tobacco) or alcohol use (i.e., ASSIST score > 26)
- (2) no reported drug use within the past 3 months
- (3) drug abuse treatment within the past 12 months
- (4) a BI at the clinic with the behavioral health counselor within the past month
- (5) prior enrollment in the parent study;
- (6) plans to move out of New Mexico in the next 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Computerized Brief Intervention
Computerized Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use.
|
No additional information needed.
|
Other: Delayed Computerized Brief Intervention
Participants receive only a substance abuse assessment at baseline.
At three-month follow-up, they then receive the computerized brief intervention.
|
No additional information needed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score
Time Frame: 3 month follow-up
|
The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk.
|
3 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score
Time Frame: 6-month follow-up
|
The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk.
|
6-month follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects Testing Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids.
Time Frame: 3-month
|
Radioimmunoassay (RIA) Tests were used.
|
3-month
|
Number of Subjects Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids
Time Frame: 6-month follow-up
|
Radioimmunoassay Testing (RIA) was conducted
|
6-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert P Schwartz, M.D., Friends Research Institute, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
September 3, 2013
First Submitted That Met QC Criteria
September 5, 2013
First Posted (Estimate)
September 6, 2013
Study Record Updates
Last Update Posted (Actual)
July 21, 2017
Last Update Submitted That Met QC Criteria
April 19, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01DA026003-B
- 1R01DA026003 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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