Substance-Related DisordersNCT00877331
Brief Intervention in Primary Care for Problem Drug Use and Abuse
A study testing Brief intervention using motivational interviewing in people with Substance-Related Disorders, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Brief intervention using motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 868 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- participation in any formal substance abuse treatment programs in the last 30 days (excluding 12-step or self-help groups)
- terminal illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98104
About this study
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.
Read the 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.
- Conditions
- Substance-Related Disorders
- Being tested
- Brief intervention using motivational interviewing
- Keywords
- Drug Abuse, Drug Addiction, Drug Dependence, Drug Usage, Drug Use Disorders, Substance Abuse, Substance Addiction, Substance Dependence, Substance Use Disorders
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief intervention using motivational interviewingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Brief intervention using motivational interviewing. One in-person session (30-45 minutes) with a brief phone follow-up one week later. Receives: Behavioral: Brief intervention using motivational interviewing |
| 2 | No intervention | Enhanced care as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 3, 6, 9, and 12 months
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.
Measured: baseline up to 2 years post-intervention
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.
Measured: baseline, 3, 6, 9, and 12 months
Secondary outcomes (3)
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).
Measured: baseline up to 2 years post-intervention
Cost of the intervention
Cost of the intervention will be measured using methods previously employed in the COMBINE study.
Measured: baseline up to 2 years post-intervention
Incremental cost-effectiveness
Incremental cost-effectiveness will be measured from the payer perspective based on health care service use and drug use frequency.
Measured: baseline up to 2 years post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionOct 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 868 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Peter Roy-Byrne, University of Washington
- Investigators
- Peter P Roy-Byrne, MD, Principal investigator, University of WashingtonKristin Bumgardner, BS, Study director, University of WashingtonAntoinette Krupski, PhD, Study chair, University of WashingtonRichard Ries, MD, Study chair, University of WashingtonChris Dunn, PhD, Study chair, University of WashingtonDennis Donovan, PhD, Study chair, University of WashingtonJutta M. Joesch, PhD, Study chair, University of WashingtonGary A. Zarkin, PhD, Study chair, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877331
- Sponsor's protocol ID
- 34892-C
- Other IDs
- R01DA026014
- Status last verified
- Oct 2014
- First submitted
- 6 Apr 2009
- Last updated
- 20 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23237456Roy-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.
PubMed 25096689
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Intervention in Primary Care for Problem Drug Use and Abuse
- ClinicalTrials.gov ID
- NCT00877331
- Acronym / sponsor ID
- 34892-C
- Conditions
- Substance-Related Disorders
- Keywords
- Drug Abuse, Drug Addiction, Drug Dependence, Drug Usage, Drug Use Disorders, Substance Abuse, Substance Addiction, Substance Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 868 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 7 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Brief intervention using motivational interviewingBrief intervention using motivational interviewing. One in-person session (30-45 minutes) with a brief phone follow-up one week later. |
| 2 | No intervention | –Enhanced care as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- participation in any formal substance abuse treatment programs in the last 30 days (excluding 12-step or self-help groups)
- terminal illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief intervention using motivational interviewingOne 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. | Behavioural | 1 |
Primary outcome
Use of illicit drugs in the past 30 days
Time frame: baseline, 3, 6, 9, and 12 months
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
Time frame: baseline up to 2 years post-intervention
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
Time frame: baseline, 3, 6, 9, and 12 months
Medical, legal, employment, social, and psychiatric outcomes will be measured by composite scores on the Addiction Severity Index (ASI) Lite.
3 secondary outcomes
Public health outcomes
Time frame: baseline up to 2 years post-intervention
Cost of the intervention
Time frame: baseline up to 2 years post-intervention
Incremental cost-effectiveness
Time frame: baseline up to 2 years post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2014.
- Background: PubMed 23237456Krupski 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 publication: PubMed 25096689Roy-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.
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Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter P Roy-Byrne, MD principal investigator
University of Washington
Kristin Bumgardner, BS study director
University of Washington
Antoinette Krupski, PhD study chair
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief intervention using motivational interviewing in people with Substance-Related Disorders, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of illicit drugs in the past 30 days (time frame: baseline, 3, 6, 9, and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00877331, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2014.