Facilitating Smoking Cessation With Reduced Nicotine Cigarettes

Smoking Cessation Clinical Trial

Official title:

Facilitating Smoking Cessation With Reduced Nicotine Cigarettes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02796391
• Other study ID #: MCC-18671
• Status: Completed
• Phase: Phase 2
• Start date: September 7, 2017
• Est. completion date: August 24, 2021

Study information

• Verified date: November 2022
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: August 24, 2021
• Est. primary completion date: August 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

• 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.).

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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.

Behavioral:
• One on One Counseling
All participants will receive One on One Counseling.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	James and Esther King Biomedical Research Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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

External Links

•   Moffitt Cancer Center Clinical Trials website