Alcohol DependencePhase 3NCT00183105
ASAP Study - Hospital-Based Brief Intervention for Alcohol Problems
A Phase 3 study testing Brief Intervention (adaptation of motivational interviewing) in people with Alcohol Dependence and Alcohol Consumption, run by Boston Medical Center at 1 site in United States.
Trial summary
The objective of this project was to test whether screening and brief intervention for unhealthy alcohol use leads to improved alcohol-related outcomes (such as alcohol consumption and linkage to alcohol assistance) and is cost-effective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Dependence, Alcohol Consumption
- What is being tested?
- Brief Intervention (adaptation of motivational interviewing)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2001to Apr 2006
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Fluent in English or Spanish
- Consume risky amounts of alcohol
- Provide 2 contacts to assist with follow-up
- Have no plans to move from the local area within a year of screening
- Score >21 on Mini-Mental State Examination (no serious cognitive impairment)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hospital-based Brief Intervention for Alcohol Problems
The objective of this project was to test whether screening and brief intervention for unhealthy alcohol use leads to improved alcohol-related outcomes (such as alcohol consumption and linkage to alcohol assistance) and is cost-effective.
Read the detailed description
In this study the effectiveness and cost-effectiveness of brief intervention for unhealthy alcohol use in a diverse group of hospitalized medical patients was tested.
We conducted a randomized trial of medical inpatients with the whole spectrum of alcohol problems from risky use through dependence. Subjects in one group received standard care; subjects in the second group received a brief motivational intervention tailored to the severity of his or her alcohol problem. Primary outcomes are alcohol consumption and linkage to alcohol treatment. Additional outcomes include health-related quality of life, health care utilization, alcohol problems, and readiness to change. Costs, and clinical outcomes measured in quality-adjusted life years, a standard metric that allows comparison to other chronic illnesses, will be compared in a cost-effectiveness analysis.
- Conditions
- Alcohol Dependence, Alcohol Consumption
- Being tested
- Brief Intervention (adaptation of motivational interviewing)
- Keywords
- Alcohol, Alcohol abuse, Alcohol dependence, Utilization, Alcohol consumption, Unhealthy alcohol use, Hospitalization, Screening, Brief Intervention, Motivational Interviewing, Randomized trial, Effectiveness, Unhealthy alcohol use (Risky alcohol consumption amounts, problem alcohol use, hazardous alcohol use, alcohol abuse and alcohol dependence)
- Medical subject headings
- Alcoholism, Alcohol Drinking, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Intervention (adaptation of motivational interviewing)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Linkage to alcohol assistance
Change in drinks per day
Secondary outcomes (9)
Change in the number of times a subject exceeded per occasion limits
Abstinence (dichotomous)
Change in drinks per day
Drinking risky amounts (dichotomous)
Binge drinking (dichotomous)
Hospitalization
Emergency Department visits
Health related quality of life
Readiness to change alcohol use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startFeb 2001
- Study completionApr 2006
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 Alcohol DependenceStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Pittsburgh, Boston University
- Investigators
- Richard Saitz, M.D., M.P.H., Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183105
- Sponsor's protocol ID
- NIAAASaitz12617-ASAP
- Other IDs
- P60AA013759, NIH AA12617
- Status last verified
- Dec 2007
- First submitted
- 9 Sep 2005
- Last updated
- 6 May 2010
- Results posted
- No
Publications
Kraemer KL, Roberts MS, Horton NJ, Palfai T, Samet JH, Freedner N, Tibbetts N, Saitz R. Health utility ratings for a spectrum of alcohol-related health states. Med Care. 2005 Jun;43(6):541-50. doi: 10.1097/01.mlr.0000163644.97251.14.
PubMed 15908848Saitz R, Palfai TP, Cheng DM, Horton NJ, Freedner N, Dukes K, Kraemer KL, Roberts MS, Guerriero RT, Samet JH. Brief intervention for medical inpatients with unhealthy alcohol use: a randomized, controlled trial. Ann Intern Med. 2007 Feb 6;146(3):167-76. doi: 10.7326/0003-4819-146-3-200702060-00005.
PubMed 17283347
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital-based Brief Intervention for Alcohol Problems
- ClinicalTrials.gov ID
- NCT00183105
- Acronym / sponsor ID
- NIAAASaitz12617-ASAP
- Conditions
- Alcohol Dependence, Alcohol Consumption
- Keywords
- Alcohol, Alcohol abuse, Alcohol dependence, Utilization, Alcohol consumption, Unhealthy alcohol use, Hospitalization, Screening
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Pittsburgh, Boston University
- Study start
- Feb 2001
- Study completion
- Apr 2006 (actual)
- First posted
- 16 Sep 2005 (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.
The objective of this project was to test whether screening and brief intervention for unhealthy alcohol use leads to improved alcohol-related outcomes (such as alcohol consumption and linkage to alcohol assistance) and is cost-effective.
Detailed description
In this study the effectiveness and cost-effectiveness of brief intervention for unhealthy alcohol use in a diverse group of hospitalized medical patients was tested.
We conducted a randomized trial of medical inpatients with the whole spectrum of alcohol problems from risky use through dependence. Subjects in one group received standard care; subjects in the second group received a brief motivational intervention tailored to the severity of his or her alcohol problem. Primary outcomes are alcohol consumption and linkage to alcohol treatment. Additional outcomes include health-related quality of life, health care utilization, alcohol problems, and readiness to change. Costs, and clinical outcomes measured in quality-adjusted life years, a standard metric that allows comparison to other chronic illnesses, will be compared in a cost-effectiveness analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- Fluent in English or Spanish
- Consume risky amounts of alcohol
- Provide 2 contacts to assist with follow-up
- Have no plans to move from the local area within a year of screening
Key exclusion criteria (0 listed)
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 (adaptation of motivational interviewing) | Behavioural | – |
Primary outcome
Linkage to alcohol assistance
Change in drinks per day
9 secondary outcomes
Change in the number of times a subject exceeded per occasion limits
Abstinence (dichotomous)
Change in drinks per day
Drinking risky amounts (dichotomous)
Binge drinking (dichotomous)
Hospitalization
Emergency Department visits
Health related quality of life
Readiness to change alcohol use
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 6 May 2010.
- Results publication: PubMed 15908848Kraemer KL, Roberts MS, Horton NJ, Palfai T, Samet JH, Freedner N, Tibbetts N, Saitz R. Health utility ratings for a spectrum of alcohol-related health states. Med Care. 2005 Jun;43(6):541-50. doi: 10.1097/01.mlr.0000163644.97251.14.
- Derived from this study: PubMed 17283347Saitz R, Palfai TP, Cheng DM, Horton NJ, Freedner N, Dukes K, Kraemer KL, Roberts MS, Guerriero RT, Samet JH. Brief intervention for medical inpatients with unhealthy alcohol use: a randomized, controlled trial. Ann Intern Med. 2007 Feb 6;146(3):167-76. doi: 10.7326/0003-4819-146-3-200702060-00005.
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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.
Richard Saitz, M.D., M.P.H. principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brief Intervention (adaptation of motivational interviewing) in people with Alcohol Dependence and Alcohol Consumption, run by Boston Medical Center 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 0 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 6 May 2010. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Linkage to alcohol assistance. The study lists 2 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 NCT00183105, 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 6 May 2010.