SmokingEarly Phase 1NCT03742154
Hollings Cancer Center Varenicline Sampling Study
A Early Phase 1 study testing Varenicline 0.5 MG 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 learn what happens when people are given a free, 4-week, sample of varenicline, a smoking cessation medication. Investigators will look at quit attempts, changes in smoking, and attitude towards varenicline, in both smokers who want to quit and those who do not. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Smoking Cessation, Smoking, Tobacco
- What is being tested?
- Varenicline 0.5 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2018to 6 Apr 2020
- Phase
- Early 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18+
- daily smoker (25+ days/previous month)
- smoking 5+ cigarettes/day;
- smoking > 1yr;
- some interest in eventual quitting (>2 on 10-point scale);
- has a primary care doctor and has seen that doctor at least once in past year; and
- own a smartphone or have regular (daily) access/use of email.
Who cannot join
- reports of history of seizures or seizure disorders;
- suicidal ideation in past month;
- any lifetime suicide attempt;
- currently pregnant, breastfeeding, or planning to become pregnant; or
- reports of hallucinations.
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: A Pilot Translational Study of Varenicline Sampling to Promote Treatment Engagement and Smoking Cessation
The purpose of this study is to learn what happens when people are given a free, 4-week, sample of varenicline, a smoking cessation medication. Investigators will look at quit attempts, changes in smoking, and attitude towards varenicline, in both smokers who want to quit and those who do not.
Smoking use causes a number of deaths and diseases, including heart disease and cancer. All smokers are advised to quit. Varenicline (sometimes called Chantix), is a prescription medication approved by the US FDA. Many studies show that use of varenicline can help smokers quit smoking.
Read more
Varenicline is a prescription medication, which usually means that people have to see a doctor to get it. This study examines a different way to deliver varenicline, delivered directly to participants for a few weeks, and without need to see a doctor. This method is called "varenicline sampling."
The study is sponsored by the Hollings Cancer Center at the Medical University of South Carolina. The study is being done at the Medical University of South Carolina, but study recruitment is based state-wide, throughout South Carolina.
- Conditions
- Smoking, Smoking Cessation, Smoking, Tobacco, Smoking, Cigarette
- Being tested
- Varenicline 0.5 MG
- Medical subject headings
- Smoking, Smoking Cessation, Tobacco Smoking, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varenicline 0.5 MGDrug
Also called Chantix, Varenicline Pill
varenicline comes in bottles of 56 - 0.5 mg pills
| Study group | Role | What they receive |
|---|---|---|
| Varenicline Group | Experimental | 50 participants will be enrolled in this group. They will receive a sample of varenicline to use for up to 4-weeks. They are receiving 40 - 0.5mg pills of varenicline, with instructions for titration. Receives: Drug: Varenicline 0.5 MG |
| Control Group | No intervention | 49 participants will be enrolled in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quit Attempts
Percent of participants with any self-defined and any self-defined 24-hr quit attempt
Measured: From study enrollment through end of three-month follow up
Secondary outcomes (1)
Conversion of Varenicline Use
Percent of participants in the sampling group using varenicline at 3-month follow up assessment.
Measured: At the end of the three-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 posted15 Nov 2018
- Study start3 Dec 2018
- Primary completion6 Apr 2020
- Study completion6 Apr 2020
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 (1)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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into one of the two study groups, like drawing numbers from a hat. One group will receive a mailed sample of varenicline, and the other will not. Participants have 50/50 chance of being in either group. Both groups will contain equal numbers of smokers motivated to quit and smokers not currently motivated to quit.
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Carpenter, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742154
- Sponsor's protocol ID
- Pro00078289
- Status last verified
- Oct 2020
- First submitted
- 12 Nov 2018
- Last updated
- 28 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carpenter MJ, Gray KM, Wahlquist AE, Cropsey K, Saladin ME, Froeliger B, Smith TT, Toll BA, Dahne J. A Pilot Randomized Clinical Trial of Remote Varenicline Sampling to Promote Treatment Engagement and Smoking Cessation. Nicotine Tob Res. 2021 May 24;23(6):983-991. doi: 10.1093/ntr/ntaa241.
PubMed 33249458
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Translational Study of Varenicline Sampling to Promote Treatment Engagement and Smoking Cessation
- ClinicalTrials.gov ID
- NCT03742154
- Acronym / sponsor ID
- Pro00078289
- Conditions
- Smoking, Smoking Cessation, Smoking, Tobacco, Smoking, Cigarette
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 6 Apr 2020 (actual)
- Study completion
- 6 Apr 2020 (actual)
- First posted
- 15 Nov 2018 (actual)
- Results
- Posted 9 Oct 2020
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 learn what happens when people are given a free, 4-week, sample of varenicline, a smoking cessation medication. Investigators will look at quit attempts, changes in smoking, and attitude towards varenicline, in both smokers who want to quit and those who do not.
Smoking use causes a number of deaths and diseases, including heart disease and cancer. All smokers are advised to quit. Varenicline (sometimes called Chantix), is a prescription medication approved by the US FDA. Many studies show that use of varenicline can help smokers quit smoking.
Varenicline is a prescription medication, which usually means that people have to see a doctor to get it. This study examines a different way to deliver varenicline, delivered directly to participants for a few weeks, and without need to see a doctor. This method is called "varenicline sampling."
The study is sponsored by the Hollings Cancer Center at the Medical University of South Carolina. The study is being done at the Medical University of South Carolina, but study recruitment is based state-wide, throughout South Carolina.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized into one of the two study groups, like drawing numbers from a hat. One group will receive a mailed sample of varenicline, and the other will not. Participants have 50/50 chance of being in either group. Both groups will contain equal numbers of smokers motivated to quit and smokers not currently motivated to quit.
| Arm | Type | Receives |
|---|---|---|
| Varenicline Group | Experimental | Drug: Varenicline 0.5 MG50 participants will be enrolled in this group. They will receive a sample of varenicline to use for up to 4-weeks. They are receiving 40 - 0.5mg pills of varenicline, with instructions for titration. |
| Control Group | No intervention | –49 participants will be enrolled in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 18+
- daily smoker (25+ days/previous month)
- smoking 5+ cigarettes/day;
- smoking > 1yr;
- some interest in eventual quitting (>2 on 10-point scale);
Key exclusion criteria (5 listed)
- reports of history of seizures or seizure disorders;
- suicidal ideation in past month;
- any lifetime suicide attempt;
- currently pregnant, breastfeeding, or planning to become pregnant; or
- reports of hallucinations.
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 |
|---|---|---|
| Varenicline 0.5 MGAlso: Chantix, Varenicline Pillvarenicline comes in bottles of 56 - 0.5 mg pills | Drug | Varenicline Group |
Primary outcome
Quit Attempts
Time frame: From study enrollment through end of three-month follow up
Percent of participants with any self-defined and any self-defined 24-hr quit attempt
1 secondary outcome
Conversion of Varenicline Use
Time frame: At the end of the three-month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33249458Carpenter MJ, Gray KM, Wahlquist AE, Cropsey K, Saladin ME, Froeliger B, Smith TT, Toll BA, Dahne J. A Pilot Randomized Clinical Trial of Remote Varenicline Sampling to Promote Treatment Engagement and Smoking Cessation. Nicotine Tob Res. 2021 May 24;23(6):983-991. doi: 10.1093/ntr/ntaa241.
- Individual participant dataSharing planned: No
Related trials for Smoking
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Varenicline 0.5 MG 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 7 inclusion and 5 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 28 Oct 2020. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 9 Oct 2020). 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?
Quit Attempts (time frame: From study enrollment through end of three-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 NCT03742154, 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 28 Oct 2020.