Use; Tobacco, HarmfulPhase 1/2NCT00907309
Dental and Medical Office iMET to Reduce Teen Tobacco, Alcohol, and Drug Use
A Phase 1/2 study testing iMET and iMET/TE in people with Use; Tobacco, Harmful and Alcohol Abuse, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The purpose of the project is to improve adolescent behavioral counseling services in healthcare settings with a new Internet/Intranet-based Motivational Enhancement Therapy (iMET) intervention that targets the use of tobacco, alcohol, and other drugs. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Use; Tobacco, Harmful, Alcohol Abuse, Drug Abuse
- What is being tested?
- iMET and iMET/TE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Sep 2012
- Phase
- Phase 1/2
- 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 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 12-21 years old
- Coming for routine care
Who cannot join
- Medically or emotionally unstable day of visit
- Already receiving behavioral health services
- Cannot read/understand English
- Will not be available for post-tests
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: Dental and Medical Office Internet/Intranet Motivational Enhancement Therapy to Reduce Teen Tobacco, Alcohol, and Drug Use
The purpose of the project is to improve adolescent behavioral counseling services in healthcare settings with a new Internet/Intranet-based Motivational Enhancement Therapy (iMET) intervention that targets the use of tobacco, alcohol, and other drugs.
Read the detailed description
We have previously developed and tested in a treatment population a promising MET program for alcohol and drug use. We will broaden the MET intervention to also target tobacco use and convert the new materials into a self-administered format.
- Conditions
- Use; Tobacco, Harmful, Alcohol Abuse, Drug Abuse
- Being tested
- iMET, iMET/TE
- Keywords
- alcohol abuse, marijuana abuse, drug abuse, tobacco use, tobacco dependence
- Medical subject headings
- Alcoholism, Substance-Related Disorders, Marijuana Abuse, Tobacco Use, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iMETBehavioural
Participants will receive the iMET intervention
iMET/TEBehavioural
Participants will receive the iMET intervention and also receive TEs (Technological Extenders)
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | No intervention | Participants will receive treatment as usual from their provider. |
| iMET | Experimental | Participants will receive the iMET intervention. Receives: Behavioral: iMET |
| iMET/TE | Experimental | Participants will receive the iMET intervention and Technological Extenders (TEs). Receives: Behavioral: iMET/TE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of tobacco, alcohol, marijuana, and other drug use
Measured: 3 months, 6 months
Secondary outcomes (1)
Rates of initiation and cessation of tobacco, alcohol, marijuana and other drug use
Measured: 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2009 (estimated)
- Study startSep 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Use; Tobacco, HarmfulStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge Health Alliance, Tufts Medical Center, Harvard School of Dental Medicine, Fallon Clinic
- Responsible party
- Principal investigator, John R Knight, MD, Boston Children's Hospital
- Investigators
- John R. Knight, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907309
- Sponsor's protocol ID
- iMET RFA-OD-09-003
- Status last verified
- Oct 2016
- First submitted
- 20 May 2009
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.
PubMed 33605440
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental and Medical Office Internet/Intranet Motivational Enhancement Therapy to Reduce Teen Tobacco, Alcohol, and Drug Use
- ClinicalTrials.gov ID
- NCT00907309
- Acronym / sponsor ID
- iMET RFA-OD-09-003
- Conditions
- Use; Tobacco, Harmful, Alcohol Abuse, Drug Abuse
- Keywords
- alcohol abuse, marijuana abuse, drug abuse, tobacco use, tobacco dependence
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Cambridge Health Alliance, Tufts Medical Center, Harvard School of Dental Medicine, Fallon Clinic
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 22 May 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.
The purpose of the project is to improve adolescent behavioral counseling services in healthcare settings with a new Internet/Intranet-based Motivational Enhancement Therapy (iMET) intervention that targets the use of tobacco, alcohol, and other drugs.
Detailed description
We have previously developed and tested in a treatment population a promising MET program for alcohol and drug use. We will broaden the MET intervention to also target tobacco use and convert the new materials into a self-administered format.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | No intervention | –Participants will receive treatment as usual from their provider. |
| iMET | Experimental | Behavioral: iMETParticipants will receive the iMET intervention. |
| iMET/TE | Experimental | Behavioral: iMET/TEParticipants will receive the iMET intervention and Technological Extenders (TEs). |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 12-21 years old
- Coming for routine care
Key exclusion criteria (4 listed)
- Medically or emotionally unstable day of visit
- Already receiving behavioral health services
- Cannot read/understand English
- Will not be available for post-tests
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 |
|---|---|---|
| iMETParticipants will receive the iMET intervention | Behavioural | iMET |
| iMET/TEParticipants will receive the iMET intervention and also receive TEs (Technological Extenders) | Behavioural | iMET/TE |
Primary outcome
Frequency of tobacco, alcohol, marijuana, and other drug use
Time frame: 3 months, 6 months
1 secondary outcome
Rates of initiation and cessation of tobacco, alcohol, marijuana and other drug use
Time frame: 3 months, 6 months
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 7 Oct 2016.
- Derived from this study: PubMed 33605440Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.
- web site of Center for Adolescent Substance Abuse Research at Children's Hospital BostonLink provided by the sponsor.
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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.
John R. Knight, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing iMET and iMET/TE in people with Use; Tobacco, Harmful and Alcohol Abuse, run by Boston Children's Hospital 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 2 inclusion and 4 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 7 Oct 2016. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Frequency of tobacco, alcohol, marijuana, and other drug use (time frame: 3 months, 6 months). 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 NCT00907309, which also lists 1 linked publication.
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 7 Oct 2016.