Facilitating Smoking Cessation With Reduced Nicotine Cigarettes

NCT02796391 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MCC-18671
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Smoking Cessation

Keywords

nicotine; cigarettes; very low nicotine content (VLNC); smoking cessation

Outcome Measures

Primary Outcomes (3)

• Study 1 - Rate of Participant Completion of Pilot

  Pilot: Complete formative research based on 15 participants to prepare for Study 2.

  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.

  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.

  At 6 Months

Study Arms (6)

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.

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.

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.

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.

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.

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.

Drug: Very Low Nicotine Content (VLNC) Cigarettes; Behavioral: One on One Counseling

Interventions

Very Low Nicotine Content (VLNC) Cigarettes DRUG

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.

Also known as: SPECTRUM®, Research Cigarettes, NOT-DA-13-002

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 Counseling BEHAVIORAL

All participants will receive One on One Counseling.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older

You may not qualify if:

• 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)
• 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)
• 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.).

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• James and Esther King Biomedical Research Program: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Smoking Cessation

Interventions

Tobacco Products

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Dr. Vani Simmons
• Organization: Moffitt Cancer Center

Vani.Simmons@moffitt.org

813-745-4816

Study Officials

• Vani Simmons, Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2016
• First Posted: June 10, 2016
• Study Start: September 7, 2017
• Primary Completion: August 24, 2021
• Study Completion: August 24, 2021
• Last Updated: November 14, 2022
• Results First Posted: October 14, 2022

Record last verified: 2022-11

Locations

US (1)