We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Facilitating Smoking Cessation With Reduced Nicotine Cigarettes

This study is currently recruiting participants.
Verified October 2017 by H. Lee Moffitt Cancer Center and Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02796391
First Posted: June 10, 2016
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
James and Esther King Biomedical Research Program
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
  Purpose

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 lead to refinements for a subsequent randomized controlled trial (RCT).

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.


Condition Intervention Phase
Smoking Cessation Drug: Very Low Nicotine Content (VLNC) Cigarettes Behavioral: One on One Counseling Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Facilitating Smoking Cessation With Reduced Nicotine Cigarettes

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Study 1 - Rate of Participant Completion of Pilot [ Time Frame: Up to 18 months ]
    Pilot: Complete formative research based on 20 participants, 10 per study arm to prepare for Study 2.

  • Study 2 - Rate of Abstinence Success [ Time Frame: Up to 24 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 prevlanece abstinence at each follow-up assessment.


Estimated Enrollment: 228
Actual Study Start Date: August 29, 2017
Estimated Study Completion Date: April 30, 2021
Estimated Primary Completion Date: April 30, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study 1: Immediate Reduction

This group will receive the lowest nicotine dose (.03 mb nicotine yield) very low nicotine content (VLNC) cigarettes, each of four pre-quit weeks (immediate reduction.

Study 1: Participants will be randomly assigned to 1 of 2 groups (Immediate or gradual nicotine reduction). They will all receive a targeted intervention workbook ("Countdown: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with brief one-on-one counseling.

Drug: Very Low Nicotine Content (VLNC) Cigarettes

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.

Other Names:
  • SPECTRUM®
  • Research Cigarettes
  • NOT-DA-13-002
Behavioral: One on One Counseling
All participants will receive One on One Counseling.
Experimental: Study 1: Gradual Reduction

This group will receive VLNC cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4 (gradual reduction).

Study 1: Participants will be randomly assigned to 1 of 2 groups (Immediate or gradual nicotine reduction). They will all receive a targeted intervention workbook ("Countdown: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with brief one-on-one counseling.

Drug: Very Low Nicotine Content (VLNC) Cigarettes

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.

Other Names:
  • SPECTRUM®
  • Research Cigarettes
  • NOT-DA-13-002
Behavioral: One on One Counseling
All participants will receive One on One Counseling.
Experimental: Study 2: Targeted/Immediate Reduction

This group will receive the lowest nicotine dose (.03 mg nicotine yield) very low nicotine content (VLNC) cigarettes, each of four pre-quit weeks (immediate reduction).

Study 2: Participants will be randomly assigned to 1 of 4 groups (Immediate or gradual nicotine reduction/ Generic or targeted intervention). They will receive either targeted ("Countdown: Preparing to Quit Smoking with Low-Nicotine Cigarettes") or generic ("Clearing the Air") materials, and will receive one-on-one counseling.

Drug: Very Low Nicotine Content (VLNC) Cigarettes

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.

Other Names:
  • SPECTRUM®
  • Research Cigarettes
  • NOT-DA-13-002
Behavioral: One on One Counseling
All participants will receive One on One Counseling.
Experimental: Study 2: Targeted/Gradual Reduction

This group will receive VLNC cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4 (gradual reduction).

Study 2: Participants will be randomly assigned to 1 of 4 groups (Immediate or gradual nicotine reduction/ Generic or targeted intervention). They will receive either targeted ("Countdown: Preparing to Quit Smoking with Low-Nicotine Cigarettes") or generic ("Clearing the Air") materials, and will receive one-on-one counseling.

Drug: Very Low Nicotine Content (VLNC) Cigarettes

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.

Other Names:
  • SPECTRUM®
  • Research Cigarettes
  • NOT-DA-13-002
Behavioral: One on One Counseling
All participants will receive One on One Counseling.
Experimental: Study 2: Generic/Immediate Reduction

This group will receive the lowest nicotine dose (.03 mg nicotine yield) very low nicotine content (VLNC) cigarettes, each of four pre-quit weeks (immediate reduction).

Study 2: Participants will be randomly assigned to 1 of 4 groups (Immediate or gradual nicotine reduction/ Generic or targeted intervention). They will receive either targeted ("Countdown: Preparing to Quit Smoking with Low-Nicotine Cigarettes") or generic ("Clearing the Air") materials, and will receive one-on-one counseling.

Drug: Very Low Nicotine Content (VLNC) Cigarettes

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.

Other Names:
  • SPECTRUM®
  • Research Cigarettes
  • NOT-DA-13-002
Behavioral: One on One Counseling
All participants will receive One on One Counseling.
Experimental: Study 2: Generic/Gradual Reduction

This group will receive VLNC cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4 (gradual reduction).

Study 2: Participants will be randomly assigned to 1 of 4 groups (Immediate or gradual nicotine reduction/ Generic or targeted intervention). They will receive either targeted ("Countdown: Preparing to Quit Smoking with Low-Nicotine Cigarettes") or generic ("Clearing the Air") materials, and will receive one-on-one counseling.

Drug: Very Low Nicotine Content (VLNC) Cigarettes

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.

Other Names:
  • SPECTRUM®
  • Research Cigarettes
  • NOT-DA-13-002
Behavioral: One on One Counseling
All participants will receive One on One Counseling.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • blood 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)
  • 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.).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796391


Contacts
Contact: Melissa Conn 813-745-1757 melissa.conn@moffitt.org
Contact: David Drobe, Ph.D.

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Melissa Conn    813-745-1757    melissa.conn@moffitt.org   
Contact: David Drobes, Ph.D.    813-745-4953    david.drobes@moffitt.org   
Principal Investigator: David Drobes, Ph.D.         
Sub-Investigator: Thomas Brandon, Ph.D.         
Sub-Investigator: David Evans, Ph.D.         
Sub-Investigator: Richard Roetzheim, M.D.         
Sub-Investigator: Vani Simmons, Ph.D.         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
James and Esther King Biomedical Research Program
Investigators
Principal Investigator: David Drobes, Ph.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT02796391     History of Changes
Other Study ID Numbers: MCC-18671
First Submitted: June 3, 2016
First Posted: June 10, 2016
Last Update Posted: October 19, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
nicotine
cigarettes
very low nicotine content (VLNC)
smoking cessation

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action