Alcohol DependencePhase 3ETMNCT00194103
Effectiveness of Extended Telephone Monitoring
A Phase 3 study testing Telephone Monitoring and Feedback and Telephone Monitoring and Counseling in people with Alcohol Dependence, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of extended telephone monitoring for alcohol-dependent patients receiving intensive outpatient treatment. It is hypothesized that telephone monitoring will produce better alcohol use outcomes relative to treatment as usual. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Telephone Monitoring and Feedback and Telephone Monitoring and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Apr 2010
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- enrolled in Intensive Outpatient substance abuse treatment for at least 2 and no more than 4 weeks at study entry
- qualify for a current DSM-IV diagnosis of alcohol dependence (during the month prior to entrance into the IOP or detoxification program prior to IOP);
- willingness to participate in research and be randomized;
- 4th grade reading level (as determined by the Slosson Oral Reading Test; Slosson, 1963);
- able to provide the names of several informants who will know his/her whereabouts during the follow-up period
Who cannot join
- acute medical or psychiatric problems that preclude outpatient treatment (e.g., in a psychotic episode and not stabilized on medication);
- IV heroin use during the past year;
- anticipated involvement in other forms of intensive treatment (e.g., inpatient) during the 6-month period after enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The purpose of this study is to determine the effectiveness of extended telephone monitoring for alcohol-dependent patients receiving intensive outpatient treatment. It is hypothesized that telephone monitoring will produce better alcohol use outcomes relative to treatment as usual. It is also hypothesized that adaptive telephone monitoring plus brief counseling will produce better alcohol use outcomes over time relative to telephone monitoring plus feedback only.
- Conditions
- Alcohol Dependence
- Being tested
- Telephone Monitoring and Feedback, Telephone Monitoring and 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 Monitoring and FeedbackBehavioural
In addition to attending IOP, participants receive phone contact from our counselors but only to receive a monitoring assessment. There is no feedback or counseling from study staff in this condition.
Telephone Monitoring and CounselingBehavioural
In addition to attending IOP, participants have phone contact with study counselors, which includes monitoring, feedback, and counseling.
| Study group | Role | What they receive |
|---|---|---|
| TAU | No intervention | Not described |
| Telephone Monitoring | Active comparator | Not described Receives: Behavioral: Telephone Monitoring and Feedback |
| Telephone Monitoring and Counseling | Experimental | Not described Receives: Behavioral: Telephone Monitoring and Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
TimeLineFollowBack
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionAug 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Investigators
- James McKay, Ph. D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194103
- Sponsor's protocol ID
- 708753
- Other IDs
- R01AA014850
- Acronym
- ETM
- Status last verified
- Jun 2010
- First submitted
- 12 Sep 2005
- Last updated
- 28 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Extended Telephone Monitoring
- ClinicalTrials.gov ID
- NCT00194103
- Acronym / sponsor ID
- ETM / 708753
- Conditions
- Alcohol Dependence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Aug 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 19 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 purpose of this study is to determine the effectiveness of extended telephone monitoring for alcohol-dependent patients receiving intensive outpatient treatment. It is hypothesized that telephone monitoring will produce better alcohol use outcomes relative to treatment as usual. It is also hypothesized that adaptive telephone monitoring plus brief counseling will produce better alcohol use outcomes over time relative to telephone monitoring plus feedback only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAU | No intervention | – |
| Telephone Monitoring | Active comparator | Behavioral: Telephone Monitoring and Feedback |
| Telephone Monitoring and Counseling | Experimental | Behavioral: Telephone Monitoring and Counseling |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- enrolled in Intensive Outpatient substance abuse treatment for at least 2 and no more than 4 weeks at study entry
- qualify for a current DSM-IV diagnosis of alcohol dependence (during the month prior to entrance into the IOP or detoxification program prior to IOP);
- willingness to participate in research and be randomized;
- 4th grade reading level (as determined by the Slosson Oral Reading Test; Slosson, 1963);
- able to provide the names of several informants who will know his/her whereabouts during the follow-up period
Key exclusion criteria (3 listed)
- acute medical or psychiatric problems that preclude outpatient treatment (e.g., in a psychotic episode and not stabilized on medication);
- IV heroin use during the past year;
- anticipated involvement in other forms of intensive treatment (e.g., inpatient) during the 6-month period after enrollment.
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 Monitoring and FeedbackIn addition to attending IOP, participants receive phone contact from our counselors but only to receive a monitoring assessment. There is no feedback or counseling from study staff in this condition. | Behavioural | Telephone Monitoring |
| Telephone Monitoring and CounselingIn addition to attending IOP, participants have phone contact with study counselors, which includes monitoring, feedback, and counseling. | Behavioural | Telephone Monitoring and Counseling |
Primary outcome
TimeLineFollowBack
Time frame: 2 years
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 28 Jun 2010.
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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.
James McKay, Ph. D. principal investigator
University of Pennsylvania
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 Monitoring and Feedback and Telephone Monitoring and Counseling in people with Alcohol Dependence, run by University of Pennsylvania 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 5 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 28 Jun 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?
TimeLineFollowBack (time frame: 2 years). 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 28 Jun 2010.