Clinical trial NCT02796391: Facilitating Smoking Cessation With Reduced Nicotine Cigarettes
Official title: Facilitating Smoking Cessation With Reduced Nicotine Cigarettes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Cessation
Keywords: nicotine
cigarettes
very low nicotine content (VLNC)
smoking cessation
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: James and Esther King Biomedical Research Program
First posted: 2016-06-10
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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)
* 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.).

Primary outcomes:
measure: Study 1 - Rate of Participant Completion of Pilot
timeFrame: Up to 2 Weeks
measure: Study 2 - Participant Abstinence Success at 2 Months
timeFrame: At 2 Months
measure: Study 2 - Participant Abstinence Success at 6 Months
timeFrame: At 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Vani Simmons, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: