Tobacco Use DisorderPhase 1PTSCNCT01654107
Persistence-Targeted Smoking Cessation
A Phase 1 study testing Persistence Targeted Smoking Cessation, Clearing The Air and Nicotine lozenge in people with Tobacco Use Disorder, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The investigators propose to develop a theory-based smoking cessation intervention (called Persistence-targeted smoking cessation; PTSC). PTSC includes 8 weekly individual counseling sessions and use of nicotine lozenge for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Persistence Targeted Smoking Cessation, Clearing The Air and Nicotine lozenge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Sep 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be between 18 - 64 years old
- Must smoke at least 10 cigarettes per day for past 6-months
- Expired breath carbon monoxide (CO) > 7
- Must have a working cellular phone
Who cannot join
- Must not be currently receiving tobacco dependence treatment counseling
- Must not currently be taking varenicline, bupropion, or any nicotine preparations (gum, lozenge, patch, spray, inhaler)
- Must have no contraindications to using nicotine lozenge
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
About this study
The investigators propose to develop a theory-based smoking cessation intervention (called Persistence-targeted smoking cessation; PTSC). PTSC includes 8 weekly individual counseling sessions and use of nicotine lozenge for 12 weeks. The investigators will test the feasibility and preliminary efficacy of the intervention (i.e., cigarettes per day and prolonged abstinence).
Read the detailed description
In this Stage I Behavioral \& Integrative Treatment Development (R34) project, we propose to develop a theory-based smoking cessation intervention (called Persistence-targeted smoking cessation; PTSC). PTSC includes 8 weekly individual counseling sessions and use of nicotine lozenge for 12 weeks. We will test the feasibility and preliminary efficacy of the intervention (i.e., cigarettes per day and prolonged abstinence). We hope to develop a feasible psychosocial treatment for use in a later randomized controlled trial.
- Conditions
- Tobacco Use Disorder
- Being tested
- Persistence Targeted Smoking Cessation, Clearing The Air, Nicotine lozenge
- Keywords
- tobacco, smoking cessation, nicotine dependence
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Persistence Targeted Smoking CessationBehavioural
Also called PTSC
8-weeks of smoking cessation counseling ("Persistence Targeted Smoking Cessation")
Clearing The AirBehavioural
Also called CTA
8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air
Nicotine lozengeDrug
12-weeks 4mg nicotine lozenge
| Study group | Role | What they receive |
|---|---|---|
| Persistence Targeted Smoking Cessation | Experimental | Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge Receives: Behavioral: Persistence Targeted Smoking Cessation; Drug: Nicotine lozenge |
| Clearing The Air | Active comparator | Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge Receives: Behavioral: Clearing The Air; Drug: Nicotine lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day Point Prevalence Abstinence
3-months after the Quit Date
Measured: 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco Use DisorderStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Marc L. Steinberg, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- Marc L Steinberg, Ph.D., Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654107
- Sponsor's protocol ID
- 0220110199
- Other IDs
- R34DA030652
- Acronym
- PTSC
- Status last verified
- Jul 2017
- First submitted
- 19 Jul 2012
- Last updated
- 21 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistence-Targeted Smoking Cessation
- ClinicalTrials.gov ID
- NCT01654107
- Acronym / sponsor ID
- PTSC / 0220110199
- Conditions
- Tobacco Use Disorder
- Keywords
- tobacco, smoking cessation, nicotine dependence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 31 Jul 2012 (estimated)
- Results
- Posted 16 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to develop a theory-based smoking cessation intervention (called Persistence-targeted smoking cessation; PTSC). PTSC includes 8 weekly individual counseling sessions and use of nicotine lozenge for 12 weeks. The investigators will test the feasibility and preliminary efficacy of the intervention (i.e., cigarettes per day and prolonged abstinence).
Detailed description
In this Stage I Behavioral \& Integrative Treatment Development (R34) project, we propose to develop a theory-based smoking cessation intervention (called Persistence-targeted smoking cessation; PTSC). PTSC includes 8 weekly individual counseling sessions and use of nicotine lozenge for 12 weeks. We will test the feasibility and preliminary efficacy of the intervention (i.e., cigarettes per day and prolonged abstinence). We hope to develop a feasible psychosocial treatment for use in a later randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Persistence Targeted Smoking Cessation | Experimental | Behavioral: Persistence Targeted Smoking Cessation, Drug: Nicotine lozengePersistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge |
| Clearing The Air | Active comparator | Behavioral: Clearing The Air, Drug: Nicotine lozengeClearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Must be between 18 - 64 years old
- Must smoke at least 10 cigarettes per day for past 6-months
- Expired breath carbon monoxide (CO) > 7
- Must have a working cellular phone
Key exclusion criteria (3 listed)
- Must not be currently receiving tobacco dependence treatment counseling
- Must not currently be taking varenicline, bupropion, or any nicotine preparations (gum, lozenge, patch, spray, inhaler)
- Must have no contraindications to using nicotine lozenge
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 |
|---|---|---|
| Persistence Targeted Smoking CessationAlso: PTSC8-weeks of smoking cessation counseling ("Persistence Targeted Smoking Cessation") | Behavioural | Persistence Targeted Smoking Cessation |
| Clearing The AirAlso: CTA8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air | Behavioural | Clearing The Air |
| Nicotine lozenge12-weeks 4mg nicotine lozenge | Drug | Clearing The Air, Persistence Targeted Smoking Cessation |
Primary outcome
7-day Point Prevalence Abstinence
Time frame: 3-months
3-months after the Quit Date
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Tobacco Use Disorder
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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.
Marc L Steinberg, Ph.D. principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Persistence Targeted Smoking Cessation, Clearing The Air and Nicotine lozenge in people with Tobacco Use Disorder, run by Rutgers, The State University of New Jersey 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 4 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 21 Aug 2017. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
7-day Point Prevalence Abstinence (time frame: 3-months). 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 21 Aug 2017.