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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01936623
Other study ID # 1R01DA026003-B
Secondary ID
Status Completed
Phase Phase 3
First received September 3, 2013
Last updated August 11, 2015
Start date August 2013
Est. completion date September 2014

Study information

Verified date August 2015
Source Friends Research Institute, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Computerized Brief Intervention
No additional information needed.

Locations

Country Name City State
United States First Choice Community Healthcare Edgewood New Mexico

Sponsors (1)

Lead Sponsor Collaborator
Friends Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Hair Testing for Drugs 3-month No
Other Hair Testing for Drugs 6-month follow-up No
Primary Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score 3 month follow-up No
Secondary Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score 6-month follow-up No
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