Smokeless Tobacco UsePhase 2NCT00680615
An Internet-Based Smokeless Tobacco Cessation Program for Teens
A Phase 2 study testing Tailored, enhanced condition in people with Smokeless Tobacco Use, run by Oregon Research Institute at 1 site in United States.
Trial summary
To compare the efficacy of a targeted, tailored, and highly interactive smokeless tobacco cessation website to a website with more static information that is similar to websites that can be found through a typical Internet search. Read more about this study
- Who is it for?
- Ages 14 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Smokeless Tobacco Use
- What is being tested?
- Tailored, enhanced condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,716 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Mar 2012
- Phase
- Phase 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 14 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 14-25 years of age
- Have access to the Internet
- Currently using smokeless tobacco products
- Currently contemplating quitting all tobacco products
- Able to read and write English; and
- Willing to share phone number, e-mail, and mailing address with the research project
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: QuitSpit: An Internet-Based Smokeless Tobacco Cessation Program for Teens
To compare the efficacy of a targeted, tailored, and highly interactive smokeless tobacco cessation website to a website with more static information that is similar to websites that can be found through a typical Internet search.
- Conditions
- Smokeless Tobacco Use
- Being tested
- Tailored, enhanced condition, Usual Care
- Keywords
- Smokeless tobacco
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored, enhanced conditionBehavioural
Intervention will provide a personalized, interactive tobacco cessation Web application, based on existing empirically validated smokeless tobacco cessation programs.
Usual CareBehavioural
The Usual Care condition will provide access to typical smokeless tobacco cessation information and links to commonly available Web-based smokeless tobacco cessation resources.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Experimental | Not described Receives: Behavioral: Usual Care |
| Enhanced | Experimental | Not described Receives: Behavioral: Tailored, enhanced condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence from all tobacco
Measured: 3 months and 6 months
Abstinence from smokeless tobacco
Measured: 3 months and 6 months
Secondary outcomes (2)
Evaluate the relative effectiveness of the two programs on secondary outcomes, including reduction in smokeless tobacco use, number of quit attempts, and confidence in quitting.
Measured: 3 months and 6 months
Identify participant characteristics, including demographic characteristics, initial smokeless tobacco use and dependence, and patterns of program use that predict treatment outcomes.
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startMay 2008
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smokeless Tobacco UseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,716 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Herbert H. Severson, PhD, Principal investigator, Oregon Research InstituteBrian G Danaher, PhD, Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680615
- Sponsor's protocol ID
- R01CA118575
- Status last verified
- Sep 2012
- First submitted
- 16 May 2008
- Last updated
- 5 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QuitSpit: An Internet-Based Smokeless Tobacco Cessation Program for Teens
- ClinicalTrials.gov ID
- NCT00680615
- Acronym / sponsor ID
- R01CA118575
- Conditions
- Smokeless Tobacco Use
- Keywords
- Smokeless tobacco
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,716 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 20 May 2008 (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.
To compare the efficacy of a targeted, tailored, and highly interactive smokeless tobacco cessation website to a website with more static information that is similar to websites that can be found through a typical Internet search.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Experimental | Behavioral: Usual Care |
| Enhanced | Experimental | Behavioral: Tailored, enhanced condition |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 14-25 years of age
- Have access to the Internet
- Currently using smokeless tobacco products
- Currently contemplating quitting all tobacco products
- Able to read and write English; and
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 |
|---|---|---|
| Tailored, enhanced conditionIntervention will provide a personalized, interactive tobacco cessation Web application, based on existing empirically validated smokeless tobacco cessation programs. | Behavioural | Enhanced |
| Usual CareThe Usual Care condition will provide access to typical smokeless tobacco cessation information and links to commonly available Web-based smokeless tobacco cessation resources. | Behavioural | Usual Care |
Primary outcome
Abstinence from all tobacco
Time frame: 3 months and 6 months
Abstinence from smokeless tobacco
Time frame: 3 months and 6 months
2 secondary outcomes
Evaluate the relative effectiveness of the two programs on secondary outcomes, including reduction in smokeless tobacco use, number of quit attempts, and confidence in quitting.
Time frame: 3 months and 6 months
Identify participant characteristics, including demographic characteristics, initial smokeless tobacco use and dependence, and patterns of program use that predict treatment outcomes.
Time frame: 3 months and 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 5 Sep 2012.
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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.
Herbert H. Severson, PhD principal investigator
Oregon Research Institute
Brian G Danaher, PhD principal investigator
Oregon Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tailored, enhanced condition in people with Smokeless Tobacco Use, run by Oregon Research Institute 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 5 Sep 2012. 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 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?
Abstinence from all tobacco (time frame: 3 months and 6 months). 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 Sep 2012.