Clinical trial NCT00877331: 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
Overall status: COMPLETED
Phase: NA
Conditions: Substance-Related Disorders
Keywords: Drug Abuse
Drug Addiction
Drug Dependence
Drug Usage
Drug Use Disorders
Substance Abuse
Substance Addiction
Substance Dependence
Substance Use Disorders
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2009-04-07
Enrollment: 868
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

1. 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.
2. To test whether fidelity to the BI model or lower severity of drug use is associated with better outcomes.
3. 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.
4. 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.

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

Primary outcomes:
measure: Use of illicit drugs in the past 30 days
timeFrame: baseline, 3, 6, 9, and 12 months
measure: Enrollment in formal substance abuse treatment
timeFrame: baseline up to 2 years post-intervention
measure: Medical, legal, employment, social, and psychiatric outcomes
timeFrame: baseline, 3, 6, 9, and 12 months
Secondary outcomes:
measure: Public health outcomes
timeFrame: baseline up to 2 years post-intervention
measure: Cost of the intervention
timeFrame: baseline up to 2 years post-intervention
measure: Incremental cost-effectiveness
timeFrame: baseline up to 2 years post-intervention
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Peter P Roy-Byrne, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Kristin Bumgardner, BS
role: STUDY_DIRECTOR
affiliation: University of Washington
name: Antoinette Krupski, PhD
role: STUDY_CHAIR
affiliation: University of Washington
name: Richard Ries, MD
role: STUDY_CHAIR
affiliation: University of Washington
name: Chris Dunn, PhD
role: STUDY_CHAIR
affiliation: University of Washington
name: Dennis Donovan, PhD
role: STUDY_CHAIR
affiliation: University of Washington
name: Jutta M. Joesch, PhD
role: STUDY_CHAIR
affiliation: RTI International
name: Gary A. Zarkin, PhD
role: STUDY_CHAIR
References:
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.
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.