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Brief Intervention in Primary Care for Problem Drug Use and Abuse

Primary Purpose

Substance-Related Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief intervention using motivational interviewing
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance-Related Disorders focused on measuring Drug Abuse, Drug Addiction, Drug Dependence, Drug Usage, Drug Use Disorders, Substance Abuse, Substance Addiction, Substance Dependence, Substance Use Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • at least 18 years old
  • receive medical care at one of the participating primary care clinics at Harborview Medical Center/University of Washington Medical Center
  • will maintain care at the clinic for one year
  • have a phone or easy access to phone, voicemail, or email
  • used recreational drugs in the last 3 months
  • used prescription medications not as prescribed in the last 3 months

Exclusion Criteria:

  • participation in any formal substance abuse treatment programs in the last 30 days (excluding 12-step or self-help groups)
  • terminal illness

Sites / Locations

  • Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Brief intervention using motivational interviewing. One in-person session (30-45 minutes) with a brief phone follow-up one week later.

Enhanced care as usual.

Outcomes

Primary Outcome Measures

Use of illicit drugs in the past 30 days
Use of illicit drugs in the past 30 days will be measured by self-reported days of use in the past 30 days and validated by urine toxicological screen.
Enrollment in formal substance abuse treatment
Enrollment in formal substance abuse treatment will be measured as an admission to chemical dependency treatment as recorded in the Washington State TARGET database.
Medical, legal, employment, social, and psychiatric outcomes
Medical, legal, employment, social, and psychiatric outcomes will be measured by composite scores on the Addiction Severity Index (ASI) Lite.

Secondary Outcome Measures

Public health outcomes
Public health outcomes will be measured by administrative data sources (emergency room visits, hospitalizations, hospital days, HIV risk behavior, arrests, and death).
Cost of the intervention
Cost of the intervention will be measured using methods previously employed in the COMBINE study.
Incremental cost-effectiveness
Incremental cost-effectiveness will be measured from the payer perspective based on health care service use and drug use frequency.

Full Information

First Posted
April 6, 2009
Last Updated
October 17, 2014
Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00877331
Brief Title
Brief Intervention in Primary Care for Problem Drug Use and Abuse
Official Title
Brief Intervention in Primary Care for Problem Drug Use and Abuse
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will examine the effectiveness of a brief intervention in a primary care setting to reduce drug use or abuse compared to enhanced care as usual.
Detailed Description
A substantial body of research has established the efficacy and effectiveness of brief interventions (BI) for excessive or "hazardous" alcohol use in patients seen in medical settings. Dissemination projects of brief interventions for alcohol and drugs have recently been implemented on a widespread scale. This rapid progression of brief intervention for drugs other than alcohol has outstripped its evidence base. The aims of the study as outlined in the grant are: To examine whether BI is effective at improving outcomes (self-reported drug use and attendance in drug abuse treatment) in individuals with a wide range of problem drug use over and above enhanced care as usual. The enhanced control condition will consist of routine screening, patient notification, and referral for treatment. To test whether fidelity to the BI model or lower severity of drug use is associated with better outcomes. To estimate the impact of BI on several public health outcomes that are directly related to the hazardous effects of illicit drug use, including the use of acute health care services, involvement in the criminal justice system, employment, HIV risk behavior, and mortality. To estimate the costs of the intervention, potential cost offsets, and its incremental cost-effectiveness versus enhanced usual care from the payer perspective based on health care service use and drug use frequency.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders
Keywords
Drug Abuse, Drug Addiction, Drug Dependence, Drug Usage, Drug Use Disorders, Substance Abuse, Substance Addiction, Substance Dependence, Substance Use Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
868 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Brief intervention using motivational interviewing. One in-person session (30-45 minutes) with a brief phone follow-up one week later.
Arm Title
2
Arm Type
No Intervention
Arm Description
Enhanced care as usual.
Intervention Type
Behavioral
Intervention Name(s)
Brief intervention using motivational interviewing
Intervention Description
One brief, in-person motivational interviewing session (30-45 minutes) in conjunction with the medical appointment. Plus one brief follow-up phone call one week later.
Primary Outcome Measure Information:
Title
Use of illicit drugs in the past 30 days
Description
Use of illicit drugs in the past 30 days will be measured by self-reported days of use in the past 30 days and validated by urine toxicological screen.
Time Frame
baseline, 3, 6, 9, and 12 months
Title
Enrollment in formal substance abuse treatment
Description
Enrollment in formal substance abuse treatment will be measured as an admission to chemical dependency treatment as recorded in the Washington State TARGET database.
Time Frame
baseline up to 2 years post-intervention
Title
Medical, legal, employment, social, and psychiatric outcomes
Description
Medical, legal, employment, social, and psychiatric outcomes will be measured by composite scores on the Addiction Severity Index (ASI) Lite.
Time Frame
baseline, 3, 6, 9, and 12 months
Secondary Outcome Measure Information:
Title
Public health outcomes
Description
Public health outcomes will be measured by administrative data sources (emergency room visits, hospitalizations, hospital days, HIV risk behavior, arrests, and death).
Time Frame
baseline up to 2 years post-intervention
Title
Cost of the intervention
Description
Cost of the intervention will be measured using methods previously employed in the COMBINE study.
Time Frame
baseline up to 2 years post-intervention
Title
Incremental cost-effectiveness
Description
Incremental cost-effectiveness will be measured from the payer perspective based on health care service use and drug use frequency.
Time Frame
baseline up to 2 years post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: at least 18 years old receive medical care at one of the participating primary care clinics at Harborview Medical Center/University of Washington Medical Center will maintain care at the clinic for one year have a phone or easy access to phone, voicemail, or email used recreational drugs in the last 3 months used prescription medications not as prescribed in the last 3 months Exclusion Criteria: participation in any formal substance abuse treatment programs in the last 30 days (excluding 12-step or self-help groups) terminal illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter P Roy-Byrne, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kristin Bumgardner, BS
Organizational Affiliation
University of Washington
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Antoinette Krupski, PhD
Organizational Affiliation
University of Washington
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Richard Ries, MD
Organizational Affiliation
University of Washington
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Chris Dunn, PhD
Organizational Affiliation
University of Washington
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dennis Donovan, PhD
Organizational Affiliation
University of Washington
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jutta M. Joesch, PhD
Organizational Affiliation
University of Washington
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gary A. Zarkin, PhD
Organizational Affiliation
RTI International
Official's Role
Study Chair
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23237456
Citation
Krupski A, Joesch JM, Dunn C, Donovan D, Bumgardner K, Lord SP, Ries R, Roy-Byrne P. Testing the effects of brief intervention in primary care for problem drug use in a randomized controlled trial: rationale, design, and methods. Addict Sci Clin Pract. 2012 Dec 14;7(1):27. doi: 10.1186/1940-0640-7-27.
Results Reference
background
PubMed Identifier
25096689
Citation
Roy-Byrne P, Bumgardner K, Krupski A, Dunn C, Ries R, Donovan D, West II, Maynard C, Atkins DC, Graves MC, Joesch JM, Zarkin GA. Brief intervention for problem drug use in safety-net primary care settings: a randomized clinical trial. JAMA. 2014 Aug 6;312(5):492-501. doi: 10.1001/jama.2014.7860.
Results Reference
result

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Brief Intervention in Primary Care for Problem Drug Use and Abuse

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