Alcohol DependencePhase 3NCT00278447
Addiction Health Evaluation And Disease Management (AHEAD) Study
A Phase 3 study testing Chronic Disease Management for substance abuse in people with Alcohol Dependence and Alcoholism, run by Boston Medical Center at 1 site in United States.
Trial summary
The objective of this study is to test whether a chronic disease management (CDM) program for substance abusers in primary care leads to improved alcohol and drug-related outcomes (such as reduced consumption and health problems) and health care utilization patterns. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Dependence, Alcoholism, Drug Dependence
- What is being tested?
- Chronic Disease Management for substance abuse
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 569 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Apr 2012
- 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
- Alcohol or drug dependent
- Heavy drinking in the past 30 days or recent drug use
- 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
- Pregnant (self-report)
- Breath alcohol >100 mg/dL
- Inability to provide informed consent determined by trained research associates
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Medical Center / Boston University
Boston, Massachusetts, 02118
About this study
Official title: Linkage of Alcohol Abusers to Primary Care
The objective of this study is to test whether a chronic disease management (CDM) program for substance abusers in primary care leads to improved alcohol and drug-related outcomes (such as reduced consumption and health problems) and health care utilization patterns.
Read the detailed description
Chronic disease management (CDM) is a collaborative, longitudinal, proven effective approach to the treatment of chronic medical illnesses that addresses individual patient and health systems barriers to receipt of needed treatment. The objective of this Addiction Health Evaluation And Disease management (AHEAD) Study is to test the effectiveness of CDM for substance dependence in primary care. The study will enroll and randomize subjects to attend a substance dependence CDM program (the AHEAD Unit) integrated into a real-world primary care clinic or to referral to usual primary care. All subjects will be assessed regarding alcohol and/or drug diagnosis, consumption and problems, readiness to change, health-related quality of life, and medical and substance abuse treatment utilization. Primary outcomes are alcohol and drug use, alcohol and drug-related problems, emergency department visits, and hospitalizations. Additional outcomes are health-related quality of life, readiness to change, medical and psychiatric comorbidity, HIV risk behaviors, and treatment utilization and costs. The hypothesis is that compared with standard care, a health services intervention -- chronic disease management for alcohol and drug dependence integrated in primary care -- will decrease alcohol and drug use and related problems, and improve health care utilization patterns.
This study contains two studies (and study populations):
- 1. 320 alcohol dependent subjects with current risky drinking, and
- 2. 320 drug dependent subjects with current drug use.
- Conditions
- Alcohol Dependence, Alcoholism, Drug Dependence
- Being tested
- Chronic Disease Management for substance abuse, Standard care
- Keywords
- Alcohol, Alcohol use, Alcohol dependence, Drug, Drug use, Drug dependence, Utilization, Hospitalization, Primary care, Chronic disease management, Care management, Comorbidity
- Medical subject headings
- Alcoholism, Substance-Related Disorders, 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.
Chronic Disease Management for substance abuseBehavioural
Referral to primary medical care \& longitudinal, multidisciplinary care for persons with substance dependence.
Standard careBehavioural
Referral to primary medical care for persons with substance dependence.
| Study group | Role | What they receive |
|---|---|---|
| 1) CDM | Active comparator | Chronic Disease Management Receives: Behavioral: Chronic Disease Management for substance abuse |
| 2) Standard care | Active comparator | Standard care Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol and drug use
Measured: 3, 6, and 12 months after baseline
Alcohol and drug-related problems
Measured: 3, 6, and 12 months after baseline
Nights Hospitalized
Measured: 3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled
Emergency department visits
Measured: 3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled
Secondary outcomes (6)
Health-related quality of life
Measured: 3, 6, and 12 months after baseline
Readiness to change
Measured: 3, 6, and 12 months after baseline
Medical comorbidity
Measured: 3, 6, and 12 months after baseline
Psychiatric comorbidity
Measured: 3, 6, and 12 months after baseline
HIV risk behaviors
Measured: 3, 6, and 12 months after baseline
Treatment utilization and costs
Measured: 3, 6, and 12 months after baseline, and up to 2 years after the last subject is enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2006 (estimated)
- Study startApr 2006
- Primary completionJan 2010
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 569 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Richard Saitz, MD, MPH, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00278447
- Sponsor's protocol ID
- SAI-010870-06A2
- Other IDs
- P60AA013759, NIAAA Grant 2R01 AA010870-06A2, NIDA Grant 2R01 DA010019-07A1
- Status last verified
- Oct 2012
- First submitted
- 13 Jan 2006
- Last updated
- 2 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Park TW, Samet JH, Cheng DM, Winter MR, Kim TW, Fitzgerald A, Saitz R. The prescription of addiction medications after implementation of chronic care management for substance dependence in primary care. J Subst Abuse Treat. 2015 May;52:17-23. doi: 10.1016/j.jsat.2014.11.008. Epub 2014 Dec 2.
PubMed 25524751Park TW, Cheng DM, Samet JH, Winter MR, Saitz R. Chronic care management for substance dependence in primary care among patients with co-occurring disorders. Psychiatr Serv. 2015 Jan 1;66(1):72-9. doi: 10.1176/appi.ps.201300414. Epub 2014 Nov 17.
PubMed 25219686Saitz R, Cheng DM, Winter M, Kim TW, Meli SM, Allensworth-Davies D, Lloyd-Travaglini CA, Samet JH. Chronic care management for dependence on alcohol and other drugs: the AHEAD randomized trial. JAMA. 2013 Sep 18;310(11):1156-67. doi: 10.1001/jama.2013.277609.
PubMed 24045740D'Amore MM, Cheng DM, Allensworth-Davies D, Samet JH, Saitz R. Disparities in safe sex counseling & behavior among individuals with substance dependence: a cross-sectional study. Reprod Health. 2012 Dec 31;9:35. doi: 10.1186/1742-4755-9-35.
PubMed 23276300
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linkage of Alcohol Abusers to Primary Care
- ClinicalTrials.gov ID
- NCT00278447
- Acronym / sponsor ID
- SAI-010870-06A2
- Conditions
- Alcohol Dependence, Alcoholism, Drug Dependence
- Keywords
- Alcohol, Alcohol use, Alcohol dependence, Drug, Drug use, Drug dependence, Utilization, Hospitalization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 569 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Apr 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 18 Jan 2006 (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 study is to test whether a chronic disease management (CDM) program for substance abusers in primary care leads to improved alcohol and drug-related outcomes (such as reduced consumption and health problems) and health care utilization patterns.
Detailed description
Chronic disease management (CDM) is a collaborative, longitudinal, proven effective approach to the treatment of chronic medical illnesses that addresses individual patient and health systems barriers to receipt of needed treatment. The objective of this Addiction Health Evaluation And Disease management (AHEAD) Study is to test the effectiveness of CDM for substance dependence in primary care. The study will enroll and randomize subjects to attend a substance dependence CDM program (the AHEAD Unit) integrated into a real-world primary care clinic or to referral to usual primary care. All subjects will be assessed regarding alcohol and/or drug diagnosis, consumption and problems, readiness to change, health-related quality of life, and medical and substance abuse treatment utilization. Primary outcomes are alcohol and drug use, alcohol and drug-related problems, emergency department visits, and hospitalizations. Additional outcomes are health-related quality of life, readiness to change, medical and psychiatric comorbidity, HIV risk behaviors, and treatment utilization and costs. The hypothesis is that compared with standard care, a health services intervention -- chronic disease management for alcohol and drug dependence integrated in primary care -- will decrease alcohol and drug use and related problems, and improve health care utilization patterns.
This study contains two studies (and study populations):
- 1. 320 alcohol dependent subjects with current risky drinking, and
- 2. 320 drug dependent subjects with current drug use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1) CDM | Active comparator | Behavioral: Chronic Disease Management for substance abuseChronic Disease Management |
| 2) Standard care | Active comparator | Behavioral: Standard careStandard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older
- Fluent in English or Spanish
- Alcohol or drug dependent
- Heavy drinking in the past 30 days or recent drug use
- Provide 2 contacts to assist with follow-up
Key exclusion criteria (3 listed)
- Pregnant (self-report)
- Breath alcohol >100 mg/dL
- Inability to provide informed consent determined by trained research associates
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 |
|---|---|---|
| Chronic Disease Management for substance abuseReferral to primary medical care \& longitudinal, multidisciplinary care for persons with substance dependence. | Behavioural | 1) CDM |
| Standard careReferral to primary medical care for persons with substance dependence. | Behavioural | 2) Standard care |
Primary outcome
Alcohol and drug use
Time frame: 3, 6, and 12 months after baseline
Alcohol and drug-related problems
Time frame: 3, 6, and 12 months after baseline
Nights Hospitalized
Time frame: 3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled
Emergency department visits
Time frame: 3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled
6 secondary outcomes
Health-related quality of life
Time frame: 3, 6, and 12 months after baseline
Readiness to change
Time frame: 3, 6, and 12 months after baseline
Medical comorbidity
Time frame: 3, 6, and 12 months after baseline
Psychiatric comorbidity
Time frame: 3, 6, and 12 months after baseline
HIV risk behaviors
Time frame: 3, 6, and 12 months after baseline
Treatment utilization and costs
Time frame: 3, 6, and 12 months after baseline, and up to 2 years after the last subject is enrolled
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 2 Oct 2014.
- Derived from this study: PubMed 25524751Park TW, Samet JH, Cheng DM, Winter MR, Kim TW, Fitzgerald A, Saitz R. The prescription of addiction medications after implementation of chronic care management for substance dependence in primary care. J Subst Abuse Treat. 2015 May;52:17-23. doi: 10.1016/j.jsat.2014.11.008. Epub 2014 Dec 2.
- Derived from this study: PubMed 25219686Park TW, Cheng DM, Samet JH, Winter MR, Saitz R. Chronic care management for substance dependence in primary care among patients with co-occurring disorders. Psychiatr Serv. 2015 Jan 1;66(1):72-9. doi: 10.1176/appi.ps.201300414. Epub 2014 Nov 17.
- Derived from this study: PubMed 24045740Saitz R, Cheng DM, Winter M, Kim TW, Meli SM, Allensworth-Davies D, Lloyd-Travaglini CA, Samet JH. Chronic care management for dependence on alcohol and other drugs: the AHEAD randomized trial. JAMA. 2013 Sep 18;310(11):1156-67. doi: 10.1001/jama.2013.277609.
- Derived from this study: PubMed 23276300D'Amore MM, Cheng DM, Allensworth-Davies D, Samet JH, Saitz R. Disparities in safe sex counseling & behavior among individuals with substance dependence: a cross-sectional study. Reprod Health. 2012 Dec 31;9:35. doi: 10.1186/1742-4755-9-35.
Related trials for Alcohol Dependence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
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, MD, MPH principal investigator
Boston University
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 Chronic Disease Management for substance abuse in people with Alcohol Dependence and Alcoholism, 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 7 inclusion and 3 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 2 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.
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?
Alcohol and drug use (time frame: 3, 6, and 12 months after baseline). The study lists 4 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 NCT00278447, which also lists 4 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 2 Oct 2014.