Facilitating Smoking Cessation With Reduced Nicotine Cigarettes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- Study 2 - Participant Abstinence Success at 2 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.).
研究组 & 干预措施
Study 1: Immediate Reduction
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.
干预措施: Very Low Nicotine Content (VLNC) Cigarettes (Drug)
Study 1: Immediate Reduction
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.
干预措施: One on One Counseling (Behavioral)
Study 1: Gradual Reduction
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.
干预措施: Very Low Nicotine Content (VLNC) Cigarettes (Drug)
Study 1: Gradual Reduction
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.
干预措施: One on One Counseling (Behavioral)
Study 2: Targeted/Immediate Reduction
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.
干预措施: Very Low Nicotine Content (VLNC) Cigarettes (Drug)
Study 2: Targeted/Immediate Reduction
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.
干预措施: One on One Counseling (Behavioral)
Study 2: Targeted/Gradual Reduction
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.
干预措施: Very Low Nicotine Content (VLNC) Cigarettes (Drug)
Study 2: Targeted/Gradual Reduction
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.
干预措施: One on One Counseling (Behavioral)
Study 2: Generic/Immediate Reduction
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.
干预措施: Very Low Nicotine Content (VLNC) Cigarettes (Drug)
Study 2: Generic/Immediate Reduction
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.
干预措施: One on One Counseling (Behavioral)
Study 2: Generic/Gradual Reduction
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.
干预措施: Very Low Nicotine Content (VLNC) Cigarettes (Drug)
Study 2: Generic/Gradual Reduction
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.
干预措施: One on One Counseling (Behavioral)
结局指标
主要结局
Study 2 - Participant Abstinence Success at 2 Months
时间窗: 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.
Study 2 - Participant Abstinence Success at 6 Months
时间窗: 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.
Study 1 - Rate of Participant Completion of Pilot
时间窗: Up to 2 Weeks
Pilot: Complete formative research based on 15 participants to prepare for Study 2.
次要结局
未报告次要终点