SmokingTipTopNCT02096029
Tobacco Intervention in Primary Care Treatment Opportunities for Providers
A study testing Nicotine Replacement Therapy (NRT) Sampling and Ask, Advise, Refer (physician brief advice) in people with Smoking and Smoking Cessation, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the use of "sampling" of smoking cessation medications (nicotine patches and lozenges) among smokers seen in primary care settings. Half of study participants will be provided with samples of medication, to use however they wish; the other half will not be provided with these… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Smoking Cessation
- What is being tested?
- Nicotine Replacement Therapy (NRT) Sampling and Ask, Advise, Refer (physician brief advice)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,278 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 15 Jun 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >=18
- daily (25+ days within past 30) cigarette smoker of >5 cigs/day
- English speaking
- recruited through primary care sites aligned with study
Who cannot join
- no FDA contraindications for use of NRT:
- not pregnant, breastfeeding, or planning to become pregnant
- no recent (past 3 months) cardiovascular trauma: MI, stroke
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Brief, Novel Smoking Cessation in Primary Care: A Comparative Effectiveness Trial
The purpose of this study is to evaluate the use of "sampling" of smoking cessation medications (nicotine patches and lozenges) among smokers seen in primary care settings. Half of study participants will be provided with samples of medication, to use however they wish; the other half will not be provided with these samples. All smokers will be advised to quit through routine contact with their physician. After the primary care contact, all participants will be contacted by phone for three brief follow-up interviews, which will involve answering questionnaires about their smoking habits.
- Conditions
- Smoking, Smoking Cessation
- Being tested
- Nicotine Replacement Therapy (NRT) Sampling, Ask, Advise, Refer (physician brief advice)
- Keywords
- smoking, smoking cessation, nicotine replacement therapy, primary care, comparative effectiveness
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Replacement Therapy (NRT) SamplingOther
2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch
Ask, Advise, Refer (physician brief advice)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Replacement Therapy (NRT) | Experimental | 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch Receives: Other: Nicotine Replacement Therapy (NRT) Sampling |
| Ask, Advise, Refer (physician brief advice) | Active comparator | Ask, Advise, Refer (physician brief advice) Receives: Behavioral: Ask, Advise, Refer (physician brief advice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With 7-Day Self-Reported Point Prevalence Abstinence
Measured: From study enrollment through end of six-month follow up
Secondary outcomes (2)
Any Self-defined Attempt to Stop Smoking Cigarettes
Measured: From study enrollment through end of six-month follow up
Use of Any Smoking Cessation Medication
Measured: From study enrollment through end of six-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startJul 2014
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Matthew Carpenter, Medical University of South Carolina
- Investigators
- Matthew J Carpenter, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096029
- Sponsor's protocol ID
- Pro00019201
- Other IDs
- 2R01DA021619
- Acronym
- TipTop
- Status last verified
- Jul 2019
- First submitted
- 21 Mar 2014
- Last updated
- 7 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.
PubMed 39868569Silvestri NJ, Dahne J, Wahlquist AE, Toll B, Carpenter MJ. Does Medication Sampling Improve Compliance with Brief Advice? Results from a Pragmatic Randomized Clinical Trial. J Smok Cessat. 2021;2021:6638872. doi: 10.1155/2021/6638872. Epub 2021 Mar 16.
PubMed 33828613
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief, Novel Smoking Cessation in Primary Care: A Comparative Effectiveness Trial
- ClinicalTrials.gov ID
- NCT02096029
- Acronym / sponsor ID
- TipTop / Pro00019201
- Conditions
- Smoking, Smoking Cessation
- Keywords
- smoking, smoking cessation, nicotine replacement therapy, primary care, comparative effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,278 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2014
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Posted 7 Aug 2019
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 evaluate the use of "sampling" of smoking cessation medications (nicotine patches and lozenges) among smokers seen in primary care settings. Half of study participants will be provided with samples of medication, to use however they wish; the other half will not be provided with these samples. All smokers will be advised to quit through routine contact with their physician. After the primary care contact, all participants will be contacted by phone for three brief follow-up interviews, which will involve answering questionnaires about their smoking habits.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotine Replacement Therapy (NRT) | Experimental | Other: Nicotine Replacement Therapy (NRT) Sampling2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch |
| Ask, Advise, Refer (physician brief advice) | Active comparator | Behavioral: Ask, Advise, Refer (physician brief advice)Ask, Advise, Refer (physician brief advice) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age >=18
- daily (25+ days within past 30) cigarette smoker of >5 cigs/day
- English speaking
- recruited through primary care sites aligned with study
Key exclusion criteria (3 listed)
- no FDA contraindications for use of NRT:
- not pregnant, breastfeeding, or planning to become pregnant
- no recent (past 3 months) cardiovascular trauma: MI, stroke
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 |
|---|---|---|
| Nicotine Replacement Therapy (NRT) Sampling2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch | Other | Nicotine Replacement Therapy (NRT) |
| Ask, Advise, Refer (physician brief advice) | Behavioural | Ask, Advise, Refer (physician brief advice) |
Primary outcome
Percentage of Participants With 7-Day Self-Reported Point Prevalence Abstinence
Time frame: From study enrollment through end of six-month follow up
2 secondary outcomes
Any Self-defined Attempt to Stop Smoking Cigarettes
Time frame: From study enrollment through end of six-month follow up
Use of Any Smoking Cessation Medication
Time frame: From study enrollment through end of six-month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39868569Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.
- Derived from this study: PubMed 33828613Silvestri NJ, Dahne J, Wahlquist AE, Toll B, Carpenter MJ. Does Medication Sampling Improve Compliance with Brief Advice? Results from a Pragmatic Randomized Clinical Trial. J Smok Cessat. 2021;2021:6638872. doi: 10.1155/2021/6638872. Epub 2021 Mar 16.
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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.
Matthew J Carpenter, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine Replacement Therapy (NRT) Sampling and Ask, Advise, Refer (physician brief advice) in people with Smoking and Smoking Cessation, run by Medical University of South Carolina 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 7 Aug 2019. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2019). 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?
Percentage of Participants With 7-Day Self-Reported Point Prevalence Abstinence (time frame: From study enrollment through end of six-month follow up). 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 NCT02096029, which also lists 2 linked publications.
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 Aug 2019.