Alcohol Use DisordersPhase 3TAMINCT00204854
Telephone and Mail Intervention for Alcohol Use Disorders
A Phase 3 study testing telephone counseling in people with Alcohol Use Disorders, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Randomized controlled trial and benefit-cost study of a telephone and mail intervention for non-treatment-seeking primary care patients with alcohol abuse or dependence Read more about this study
- Who is it for?
- Ages 21 to 59 years
- Conditions the study is for
- Alcohol Use Disorders
- What is being tested?
- telephone counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2001to Nov 2004
- 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 21 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- primary care patients with DSM-IV alcohol abuse or dependence
Who cannot join
- pregnancy
- suicidality
- alcohol treatment in prior 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Randomized controlled trial and benefit-cost study of a telephone and mail intervention for non-treatment-seeking primary care patients with alcohol abuse or dependence
- Conditions
- Alcohol Use Disorders
- Being tested
- telephone counseling
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone counselingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported alcohol consumption in the prior 28 days
Number of risky drinking days in the prior 28 days
Secondary outcomes (3)
Health care utilization
car crashes
criminal justice system involvement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startDec 2001
- Primary completionJun 2004
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisordersStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 900 participants
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Richard L Brown, MD, MPH, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204854
- Sponsor's protocol ID
- 1999-514
- Other IDs
- 1R01AA012826
- Acronym
- TAMI
- Status last verified
- Jan 2011
- First submitted
- 12 Sep 2005
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone and Mail Intervention for Alcohol Use Disorders
- ClinicalTrials.gov ID
- NCT00204854
- Acronym / sponsor ID
- TAMI / 1999-514
- Conditions
- Alcohol Use Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Dec 2001
- Primary completion
- Jun 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 20 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.
Randomized controlled trial and benefit-cost study of a telephone and mail intervention for non-treatment-seeking primary care patients with alcohol abuse or dependence
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 21 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- primary care patients with DSM-IV alcohol abuse or dependence
Key exclusion criteria (3 listed)
- pregnancy
- suicidality
- alcohol treatment in prior 3 months
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 |
|---|---|---|
| telephone counseling | Behavioural | – |
Primary outcome
Self-reported alcohol consumption in the prior 28 days
Number of risky drinking days in the prior 28 days
3 secondary outcomes
Health care utilization
car crashes
criminal justice system involvement
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 5 Oct 2015.
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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 L Brown, MD, MPH principal investigator
University of Wisconsin, Madison
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 telephone counseling in people with Alcohol Use Disorders, run by University of Wisconsin, Madison 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 1 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 5 Oct 2015. 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?
Self-reported alcohol consumption in the prior 28 days. 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?
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 5 Oct 2015.