NCT01936623

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2013

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

Study Start

First participant enrolled

August 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 3, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

July 21, 2017

Completed
Last Updated

July 21, 2017

Status Verified

April 1, 2017

Enrollment Period

1.1 years

First QC Date

September 3, 2013

Results QC Date

January 13, 2017

Last Update Submit

April 19, 2017

Conditions

Keywords

brief interventioncomputerized brief intervention

Outcome Measures

Primary Outcomes (1)

  • Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score

    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 Outcomes (1)

  • Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score

    6-month follow-up

Other Outcomes (2)

  • Number of Subjects Testing Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids.

    3-month

  • Number of Subjects Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids

    6-month follow-up

Study Arms (2)

Computerized Brief Intervention

EXPERIMENTAL

Computerized Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use.

Behavioral: Computerized Brief Intervention

Delayed Computerized Brief Intervention

OTHER

Participants receive only a substance abuse assessment at baseline. At three-month follow-up, they then receive the computerized brief intervention.

Behavioral: Computerized Brief Intervention

Interventions

No additional information needed.

Computerized Brief InterventionDelayed Computerized Brief Intervention

Eligibility Criteria

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

You may qualify if:

  • (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.

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Choice Community Healthcare

Edgewood, New Mexico, 87015, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Robert Schwartz, M.D.
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
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2013

First Posted

September 6, 2013

Study Start

August 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

July 21, 2017

Results First Posted

July 21, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations