Tobacco AddictionPhase 4EDCNCT01038414
Duration of Behavioral Counseling Treatment Needed to Optimize Smoking Abstinence
A Phase 4 study testing Extended Duration Behavioral Smoking Cessation Counseling in people with Tobacco Addiction, run by Harvard University Faculty of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine if extending the behavioral smoking-cessation treatment period to one year will significantly improve cessation outcomes among those planning a quit attempt. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Addiction
- What is being tested?
- Extended Duration Behavioral Smoking Cessation Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jan 2013
- Phase
- Phase 4
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Daily Cigarette Smokers
Who cannot join
- Smokers with active atherosclerotic heart disease, severe cardiac arrhythmias, uncontrolled hypertension, severe peripheral vascular disease, pre-controlled diabetes mellitus, pregnancy, lactation or likely to become pregnant during the study period, and chronic dermatologic disease.
- Smokers who meet DSM-IV lifetime criteria for conditions such as schizo-affective disorder and schizophrenia, bi-polar disorder, or who have had alcohol or drug dependence issues within the past year.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Harvard School of Dental Medicine
Boston, Massachusetts, 02115
Arthur J Garvey, PhD, 617-523-8558, arthur_garvey@hms.harvard.edu
Arthur J Garvey, Ph.D.
About this study
The purpose of this study is to determine if extending the behavioral smoking-cessation treatment period to one year will significantly improve cessation outcomes among those planning a quit attempt.
- Conditions
- Tobacco Addiction
- Being tested
- Extended Duration Behavioral Smoking Cessation Counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended Duration Behavioral Smoking Cessation CounselingBehavioural
Also called Extended-Duration Behvioral Smoking-Cessation Counseling
Subjects are randomized to one of 3 behavioral treatments: (1) Brief Duration (3 month) smoking-cessation counseling; (2) Moderate Duration (6 month) counseling; or (3) Extended Duration (12 month) counseling
| Study group | Role | What they receive |
|---|---|---|
| Brief-Duration Counseling | Placebo comparator | 3-Month Duration Receives: Behavioral: Extended Duration Behavioral Smoking Cessation Counseling |
| Moderate Duration Counseling | Active comparator | 6-Month Duration Receives: Behavioral: Extended Duration Behavioral Smoking Cessation Counseling |
| Extended Duration Counseling | Active comparator | 12-Month Duration Receives: Behavioral: Extended Duration Behavioral Smoking Cessation Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects abstinent by treatment group at 1 year post-cessation.
Measured: One year
Secondary outcomes (1)
Proportion of subjects abstinent by treatment group at 2 years post-cessation.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startFeb 2008
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco AddictionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard University Faculty of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038414
- Sponsor's protocol ID
- 5R01DA12165-8
- Other IDs
- 5R01DA012165
- Acronym
- EDC
- Status last verified
- Jun 2011
- First submitted
- 22 Dec 2009
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Behavioral Counseling Treatment Needed to Optimize Smoking Abstinence
- ClinicalTrials.gov ID
- NCT01038414
- Acronym / sponsor ID
- EDC / 5R01DA12165-8
- Conditions
- Tobacco Addiction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Harvard University Faculty of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Feb 2008
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 24 Dec 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 this study is to determine if extending the behavioral smoking-cessation treatment period to one year will significantly improve cessation outcomes among those planning a quit attempt.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brief-Duration Counseling | Placebo comparator | Behavioral: Extended Duration Behavioral Smoking Cessation Counseling3-Month Duration |
| Moderate Duration Counseling | Active comparator | Behavioral: Extended Duration Behavioral Smoking Cessation Counseling6-Month Duration |
| Extended Duration Counseling | Active comparator | Behavioral: Extended Duration Behavioral Smoking Cessation Counseling12-Month Duration |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Daily Cigarette Smokers
Key exclusion criteria (2 listed)
- Smokers with active atherosclerotic heart disease, severe cardiac arrhythmias, uncontrolled hypertension, severe peripheral vascular disease, pre-controlled diabetes mellitus, pregnancy, lactation or likely to become pregnant during the study period, and chronic dermatologic disease.
- Smokers who meet DSM-IV lifetime criteria for conditions such as schizo-affective disorder and schizophrenia, bi-polar disorder, or who have had alcohol or drug dependence issues within the past year.
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 |
|---|---|---|
| Extended Duration Behavioral Smoking Cessation CounselingAlso: Extended-Duration Behvioral Smoking-Cessation CounselingSubjects are randomized to one of 3 behavioral treatments: (1) Brief Duration (3 month) smoking-cessation counseling; (2) Moderate Duration (6 month) counseling; or (3) Extended Duration (12 month) counseling | Behavioural | Brief-Duration Counseling, Extended Duration Counseling, Moderate Duration Counseling |
Primary outcome
Proportion of subjects abstinent by treatment group at 1 year post-cessation.
Time frame: One year
1 secondary outcome
Proportion of subjects abstinent by treatment group at 2 years post-cessation.
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Extended Duration Behavioral Smoking Cessation Counseling in people with Tobacco Addiction, run by Harvard University Faculty of Medicine 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 2 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: status not confirmed, as of the sponsor's last update on 23 Jun 2011. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects abstinent by treatment group at 1 year post-cessation. (time frame: One year). 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 23 Jun 2011; AzTrials last refreshed its copy on 7 Nov 2026.