Smoking CessationPhase 2NCT02796391

Facilitating Smoking Cessation With Reduced Nicotine Cigarettes

A Phase 2 study testing Very Low Nicotine Content (VLNC) Cigarettes and One on One Counseling in people with Smoking Cessation, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

STUDY 1: INTERVENTION DEVELOPMENT The purpose of this study is to determine the best way to help people stop smoking by using very low nicotine content (VLNC) cigarettes. This developmental pilot study (n=20) will determine the feasibility of the treatment approach and methodology using a targeted intervention, and… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Smoking Cessation
What is being tested?: Very Low Nicotine Content (VLNC) Cigarettes and One on One Counseling
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 163 participants
Where: 1 siteUnited States
Study dates: 7 Sep 2017to 24 Aug 2021
Phase: Phase 2
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

smoke at least 5 cigarettes daily for the past year
expired-air carbon monoxide (CO) > 8 ppm (if ≤ 8 ppm, then NicAlert Strip > 2)
current motivation to quit smoking
able to speak and read English sufficiently for completion of consent form and questionnaires
18 years of age or older

Who cannot join

pregnant or breastfeeding
significant unstable medical/psychiatric or substance use disorders, or medically/psychiatrically at risk in the judgment of the study physician or principal investigator (PI)
positive urine screen for cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, or PCP (NOTES: THC will be tested but will not be an exclusionary criterion; participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded; participants failing the toxicology screen will be allowed to re-screen once)
breath alcohol level > 0.01 (one re-screen allowed)
binge alcohol drinking (4/5 [female/male] drinks per day more than 9 days in the past month)
systolic/diastolic blood pressure (BP) greater than or equal to 160/100, or below 90/50 (one re-screen allowed)

Show all 14Show fewer

heart rate greater than or equal to 105 beats per minute (bpm), or below 45 bpm (one re-screen allowed)
ever used reduced nicotine cigarettes
smoke 'roll your own' cigarettes exclusively
used smoking cessation medications within the past three months
are currently enrolled in a smoking cessation program
actively trying to quit
used other tobacco products (including e-cigarettes more than 9 days in the past month
currently taking the following medications: Phenytoin [Brand Name: Dilantin]; Carbamazepine [Brand Name: Tegretol, Carbatrol, Equetro, Epitol]; Oxcarbazepine [Brand Name: Trileptal]; Primidone [Brand Name: Mysoline]; Phenobarbital; Bendamustine (Treanda); Clopidogrel (Plavix); Clozapine (Clozaril, FazaClo); Erlotinib (Tarceva); Flecainide (Tambocor); Fluvoxamine (Luvox); Irinotecan (Camptosar); Olanzapine (Zyprexa); Ropinirole (Requip); Tacrine (Cognex); Theophylline (Theo Dur, etc.).

Trial locations and contacts

1 site in 1 country.

United States1 site

H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612

Other trials in United States

About this study

STUDY 2: RANDOMIZED CONTROLLED TRIAL The purpose of this study is to see if a targeted intervention will help people to stop or reduce smoking better than a standard intervention using very low nicotine content (VLNC) cigarettes, and to determine the optimal nicotine tapering schedule (gradual vs. immediate) during a 5-week pre-quit period. About 208 participants will take part in this phase of the study at Moffitt Cancer Center.

Read the detailed description

The current project will (1) develop a theory-based, user-friendly, and efficient set of targeted cessation materials to facilitate extinction during pre-quit VLNC smoking, (2) establish the feasibility of recruitment and measurement strategies to be used in the RCT, (3) determine whether immediate vs. gradual pre-quit nicotine tapering in combination with the targeted behavioral intervention has beneficial effects (on cessation-related and intermediate outcomes) for eventual comparison with validated cessation methods (e.g., NRT), and (4) examine several potential moderators and mediators of treatment efficacy.

Conditions: Smoking Cessation
Being tested: Very Low Nicotine Content (VLNC) Cigarettes, One on One Counseling
Keywords: nicotine, cigarettes, very low nicotine content (VLNC), smoking cessation
Medical subject headings: Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Very Low Nicotine Content (VLNC) CigarettesDrug
Also called SPECTRUM®, Research Cigarettes, NOT-DA-13-002
Eligible participants will receive a 1-week supply (based on typical # cigarettes/day x 1.5) of normal nicotine content (NNC) (.8 mg nicotine yield) study cigarettes to smoke exclusively during one baseline week.
Study 1: Participants (n=20) will then be randomly selected to receive either the lowest nicotine dose of VLNC cigarettes, or gradual decreasing nicotine VLNC cigarettes, ten participants per each group, over the next four weeks.
Study 2: Participants (n=208) will be randomly assigned to 1 of 4 Study 2 Reduction Arms, 52 participants per arm.
One on One CounselingBehavioural
All participants will receive One on One Counseling.

Study groups in NCT02796391
Study group	Role	What they receive
Study 1: Immediate Reduction	Experimental	Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling. Receives: Drug: Very Low Nicotine Content (VLNC) Cigarettes; Behavioral: One on One Counseling
Study 1: Gradual Reduction	Experimental	Participants will receive VLNC (very low nicotine cigarettes) containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4.They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling. Receives: Drug: Very Low Nicotine Content (VLNC) Cigarettes; Behavioral: One on One Counseling
Study 2: Targeted/Immediate Reduction	Experimental	Participants will receive VLNC (very low nicotine cigarettes) containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4.They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling. Receives: Drug: Very Low Nicotine Content (VLNC) Cigarettes; Behavioral: One on One Counseling
Study 2: Targeted/Gradual Reduction	Experimental	Participants will receive VLNC (very low nicotine cigarettes) containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive targeted materials (booklet series entitled ("Count down: Preparing to Quit Smoking with low-Nicotine Cigarettes") as well as one-on-one counseling. Receives: Drug: Very Low Nicotine Content (VLNC) Cigarettes; Behavioral: One on One Counseling
Study 2: Generic/Immediate Reduction	Experimental	Participants will receive VLNC (very low nicotine cigarettes) with the lowest nicotine dose (.03 mb nicotine yield). Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling. Receives: Drug: Very Low Nicotine Content (VLNC) Cigarettes; Behavioral: One on One Counseling
Study 2: Generic/Gradual Reduction	Experimental	Participants will receive VLNC (very low nicotine cigarettes) containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling. Receives: Drug: Very Low Nicotine Content (VLNC) Cigarettes; Behavioral: One on One Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

Study 1 - Rate of Participant Completion of Pilot
Pilot: Complete formative research based on 15 participants to prepare for Study 2.
Measured: Up to 2 Weeks
Study 2 - Participant Abstinence Success at 2 Months
Participants reporting 7-day point prevalence abstinence at 2 months
RCT: The purpose of Study 2 is to test effects of the targeted intervention developed in Study 1 on smoking cessation. Comparison of abstinence success per treatment arm, utilizing 7-day point prevalence abstinence at each follow-up assessment.
Measured: At 2 Months
Study 2 - Participant Abstinence Success at 6 Months
Participants reporting 7-day point prevalence abstinence at 6 months
RCT: The purpose of Study 2 is to test effects of the targeted intervention developed in Study 1 on smoking cessation. Comparison of abstinence success per treatment arm, utilizing 7-day point prevalence abstinence at each follow-up assessment.
Measured: At 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Sep 201724 Aug 2021

First posted10 Jun 2016 (estimated)
Study start7 Sep 2017
Primary completion24 Aug 2021
Study completion24 Aug 2021

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 Smoking CessationStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 163 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02796391
Sponsor's protocol ID: MCC-18671
Status last verified: Nov 2022
First submitted: 3 Jun 2016
Last updated: 14 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Smoking Cessation trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Facilitating Smoking Cessation With Reduced Nicotine Cigarettes
ClinicalTrials.gov ID: NCT02796391
Acronym / sponsor ID: MCC-18671
Conditions: Smoking Cessation
Keywords: nicotine, cigarettes, very low nicotine content (VLNC), smoking cessation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 163 participants (actual)
Lead sponsor: H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
Collaborators: James and Esther King Biomedical Research Program
Study start: 7 Sep 2017 (actual)
Primary completion: 24 Aug 2021 (actual)
Study completion: 24 Aug 2021 (actual)
First posted: 10 Jun 2016 (estimated)
Results: Posted 14 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Study 1: Immediate Reduction	Experimental	Drug: Very Low Nicotine Content (VLNC) Cigarettes, Behavioral: One on One CounselingParticipants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling.
Study 1: Gradual Reduction	Experimental	Drug: Very Low Nicotine Content (VLNC) Cigarettes, Behavioral: One on One CounselingParticipants will receive VLNC (very low nicotine cigarettes) containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4.They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling.
Study 2: Targeted/Immediate Reduction	Experimental	Drug: Very Low Nicotine Content (VLNC) Cigarettes, Behavioral: One on One CounselingParticipants will receive VLNC (very low nicotine cigarettes) containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4.They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling.
Study 2: Targeted/Gradual Reduction	Experimental	Drug: Very Low Nicotine Content (VLNC) Cigarettes, Behavioral: One on One CounselingParticipants will receive VLNC (very low nicotine cigarettes) containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive targeted materials (booklet series entitled ("Count down: Preparing to Quit Smoking with low-Nicotine Cigarettes") as well as one-on-one counseling.
Study 2: Generic/Immediate Reduction	Experimental	Drug: Very Low Nicotine Content (VLNC) Cigarettes, Behavioral: One on One CounselingParticipants will receive VLNC (very low nicotine cigarettes) with the lowest nicotine dose (.03 mb nicotine yield). Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling.
Study 2: Generic/Gradual Reduction	Experimental	Drug: Very Low Nicotine Content (VLNC) Cigarettes, Behavioral: One on One CounselingParticipants will receive VLNC (very low nicotine cigarettes) containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

smoke at least 5 cigarettes daily for the past year
expired-air carbon monoxide (CO) > 8 ppm (if ≤ 8 ppm, then NicAlert Strip > 2)
current motivation to quit smoking
able to speak and read English sufficiently for completion of consent form and questionnaires
18 years of age or older

Key exclusion criteria (14 listed)

pregnant or breastfeeding
significant unstable medical/psychiatric or substance use disorders, or medically/psychiatrically at risk in the judgment of the study physician or principal investigator (PI)
positive urine screen for cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, or PCP (NOTES: THC will be tested but will not be an exclusionary criterion; participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded; participants failing the toxicology screen will be allowed to re-screen once)
breath alcohol level > 0.01 (one re-screen allowed)
binge alcohol drinking (4/5 [female/male] drinks per day more than 9 days in the past month)

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
Very Low Nicotine Content (VLNC) CigarettesAlso: SPECTRUM®, Research Cigarettes, NOT-DA-13-002Eligible participants will receive a 1-week supply (based on typical # cigarettes/day x 1.5) of normal nicotine content (NNC) (.8 mg nicotine yield) study cigarettes to smoke exclusively during one baseline week. Study 1: Participants (n=20) will then be randomly selected to receive either the lowest nicotine dose of VLNC cigarettes, or gradual decreasing nicotine VLNC cigarettes, ten participants per each group, over the next four weeks. Study 2: Participants (n=208) will be randomly assigned to 1 of 4 Study 2 Reduction Arms, 52 participants per arm.	Drug	Study 1: Gradual Reduction, Study 1: Immediate Reduction, Study 2: Generic/Gradual Reduction, Study 2: Generic/Immediate Reduction, Study 2: Targeted/Gradual Reduction, Study 2: Targeted/Immediate Reduction
One on One CounselingAll participants will receive One on One Counseling.	Behavioural	Study 1: Gradual Reduction, Study 1: Immediate Reduction, Study 2: Generic/Gradual Reduction, Study 2: Generic/Immediate Reduction, Study 2: Targeted/Gradual Reduction, Study 2: Targeted/Immediate Reduction

Primary outcome

Study 1 - Rate of Participant Completion of Pilot
Time frame: Up to 2 Weeks
Pilot: Complete formative research based on 15 participants to prepare for Study 2.
Study 2 - Participant Abstinence Success at 2 Months
Time frame: At 2 Months
Participants reporting 7-day point prevalence abstinence at 2 months RCT: The purpose of Study 2 is to test effects of the targeted intervention developed in Study 1 on smoking cessation. Comparison of abstinence success per treatment arm, utilizing 7-day point prevalence abstinence at each follow-up assessment.
Study 2 - Participant Abstinence Success at 6 Months
Time frame: At 6 Months
Participants reporting 7-day point prevalence abstinence at 6 months RCT: The purpose of Study 2 is to test effects of the targeted intervention developed in Study 1 on smoking cessation. Comparison of abstinence success per treatment arm, utilizing 7-day point prevalence abstinence at each follow-up assessment.

Results and safety

Results posted to the registry on 14 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study 1: Immediate Reduction	7	4
Study 1: Gradual Reduction	8	5
Study 2: Targeted/Immediate Reduction	41	16
Study 2: Targeted/Gradual Reduction	32	14
Study 2: Generic/Immediate Reduction	34	14
Study 2: Generic/Gradual Reduction	40	20

Primary outcome: Study 1 - Rate of Participant Completion of Pilot

Time frame: Up to 2 Weeks. Count of participants. Unit: Participants

Measure	Study 1: Immediate Reduction n = 7	Study 1: Gradual Reduction n = 8
Value	4	5

Primary outcome: Study 2 - Participant Abstinence Success at 2 Months

Time frame: At 2 Months. Number. Unit: participants

Measure	Study 2: Targeted/Immediate Reduction n = 41	Study 2: Targeted/Gradual Reduction n = 32	Study 2: Generic/Immediate Reduction n = 34	Study 2: Generic/Gradual Reduction n = 40
Value	12	8	10	13

Primary outcome: Study 2 - Participant Abstinence Success at 6 Months

Time frame: At 6 Months. Number. Unit: participants

Measure	Study 2: Targeted/Immediate Reduction n = 41	Study 2: Targeted/Gradual Reduction n = 32	Study 2: Generic/Immediate Reduction n = 34	Study 2: Generic/Gradual Reduction n = 40
Value	10	7	6	10

Adverse events

Time frame: Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study 1: Immediate Reduction	0 of 7 (0%)	5 of 7 (71.4%)	0 of 7
Study 1: Gradual Reduction	0 of 8 (0%)	3 of 8 (37.5%)	0 of 8
Study 2: Targeted/Immediate Reduction	0 of 41 (0%)	25 of 41 (61%)	0 of 41
Study 2: Targeted/Gradual Reduction	3 of 32 (9.4%)	20 of 32 (62.5%)	0 of 32
Study 2: Generic/Immediate Reduction	1 of 34 (2.9%)	24 of 34 (70.6%)	0 of 34
Study 2: Generic/Gradual Reduction	2 of 40 (5%)	27 of 40 (67.5%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Moffitt Cancer Center Clinical Trials websiteLink provided by the sponsor.

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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.

Vani Simmons, Ph.D. principal investigator

H. Lee Moffitt Cancer Center and Research Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 14 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 14 Nov 2022. 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?

Yes. Results are posted in the registry (first posted 14 Oct 2022). 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?

Study 1 - Rate of Participant Completion of Pilot (time frame: Up to 2 Weeks). The study lists 3 primary outcomes in all. 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 NCT02796391.

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 14 Nov 2022.