Strengthening Instrumental Extinction to Prevent Smoking Relapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Change in Fagerstrom Test of Nicotine Dependence Score
研究概览
简要总结
The central objective of the project is to evaluate the effect of incorporating smoking related contexts into very low nicotine content (VLNC) cigarette extinction trials on clinically relevant, smoking-related outcomes. Adult smokers interested in quitting smoking (N=80) will be interviewed and trained to take pictures where they smoke cigarettes. Following taking these pictures, participants will then be switched to smoke VLNCs while wearing a 21 mg/d nicotine patch (EXT) for three weeks. During this 3-week treatment period, half of the sample (n=40) will be randomly assigned to undergo six, 60-minute sessions of multiple context extinction (MCE+) during which they will view smoking-related environments and smoke their assigned cigarettes. The remaining 40 participants will undergo control MCE (exposure to nature environments; MCE-) and smoke their assigned cigarettes. At the end of the three weeks, participants will quit smoking and continue to wear the nicotine patch while being followed during a 10-week abstinence period. Participants will also complete a follow-up phone call 6 months after their quit day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •generally healthy (i.e. ambulatory, not currently sick)
- •interest in quitting smoking
- •smoking of at least 5 cig/day of a brand delivering ≥ 0.5 mg nicotine (FTC method) for > 1 year
- •an expired carbon monoxide concentration of at least 10 ppm (to confirm inhalation) or urinary cotinine > 1000 ng/mL to confirm daily smoking (NicAlert=6)
排除标准
- •inability to attend all required experimental sessions
- •desire to quit smoking prior to the study quit date
- •a quit attempt resulting in greater than 3 days of abstinence in the past 30 days
- •report of significant health problems including but not restricted to (e.g. chronic hypertension, emphysema, seizure disorder, history of significant heart problems)
- •unstable psychiatric conditions (any significant change in psychiatric symptoms during the past 3 months as determined by the study physician)
- •schizophrenia and schizoaffective disorder
- •psychiatric medication changes (e.g. new prescriptions, changes in dosages, or discontinuation of medications) in the past 3 months that was a result of negative changes in symptoms
- •use of other tobacco products or e-cigarettes more than 9 days in the past 30 days
- •current alcohol or drug abuse
- •use of illegal drugs (excluding marijuana) or drugs without a valid prescription as measured by urine drug screen
- •current use of nicotine replacement therapy or other smoking cessation treatment
- •use of Theophylline for asthma
- •presence of conditions contraindicated for nicotine replacement therapy (e.g., skin allergies)
- •previous participation in a study within the past year involving use of Spectrum cigarettes
- •systolic BP greater than or equal to 140 (participants failing for blood pressure will be allowed to rescreen once)
- •diastolic BP greater than or equal to 90 (participants failing for blood pressure will be allowed to rescreen once)
- •heart rate greater than or equal to 100 (participants failing for heart rate will be allowed to rescreen once)
- •blood alcohol level >0.0 (participants failing the blood alcohol screen will be allowed to rescreen once)
- •pregnant, trying to become pregnant, or breastfeeding
研究组 & 干预措施
MCE+
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
干预措施: Nicotine Patch (Drug)
MCE+
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
干预措施: SPECTRUM Nicotine Research Cigarettes (0.07 mg) (Drug)
MCE+
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
干预措施: MCE+ (Behavioral)
MCE- (Control)
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
干预措施: Nicotine Patch (Drug)
MCE- (Control)
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
干预措施: SPECTRUM Nicotine Research Cigarettes (0.07 mg) (Drug)
MCE- (Control)
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
干预措施: MCE- (Behavioral)
结局指标
主要结局
Change in Fagerstrom Test of Nicotine Dependence Score
时间窗: baseline - week 6
Effects of MCE+ (vs. MCE-) on pre-quit nicotine dependence. The score of the questionnaire ranges in value from 0 (not at all dependent) to 10 (highly dependent).
Number of Participants Who Met Relapse Criteria
时间窗: week 16
Effects of MCE+ (vs. MCE-) on smoking cessation outcomes. Relapse is defined as 7 consecutive days of smoking. Outcome reported as number of participants who met relapse definition.
次要结局
- Change From Baseline in Number of Usual Brand Cigarettes Smoked (EXT Engagement)(week 1, week 6)
- Change in Number of Cigarettes Smoked Per Day (EXT Response)(week 3, week 6)
- Change in Craving Score During MCE Task (MCE Response)(week 3, week 4, week 5)
- Change in Post-quit Cue-reactivity(baseline ,week 6)
研究者
Francis McClernon, Ph.D.
Associate Professor
Duke University