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Completed

NCT Number: NCT02796391

Facilitating Smoking Cessation With Reduced Nicotine Cigarettes

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

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.

Other names: SPECTRUM®, Research Cigarettes, NOT-DA-13-002

One on One Counseling

Behavioral

All participants will receive One on One Counseling.

Primary outcomes

  1. 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.

  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.

  3. 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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • James and Esther King Biomedical Research Program

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 10, 2016
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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