Targeting Reward Dysfunction as a Mechanism to Improve Smoking Cessation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in BOLD (Blood-oxygen-level-dependent) Response to Smoking Reward
研究概览
简要总结
The goal of this study is to evaluate the effects of a smoking cessation intervention combining behavioral treatment with low nicotine cigarettes on neuroimaging measures of reward function and smoking cessation outcomes. The results of this study will provide information about mechanisms contributing to smoking and smoking cessation and will help to guide future treatment studies.
详细描述
Smokers who are interested in quitting will be randomly assigned to one of two treatment conditions. In the BA +VLNC condition (n = 16) smokers will switch to smoking very low nicotine cigarettes (VLNCs) while wearing a 21 mg/d nicotine patch for 5 weeks prior to their quit date. They will also participate in weekly behavioral activation (BA) treatment sessions. Smokers in the VLNC Only group (n = 19) will undergo the same pharmacological pretreatment but will undergo standard counseling and health education instead of BA. Following the quit date, both groups will receive standard nicotine replacement therapy. At baseline and pre-quit, BOLD response to smoking and non-smoking rewards will be measured using fMRI after 24 hr abstinence. Latency to relapse will serve as a continuous clinical outcome measure. Participants will also receive follow-up phone calls at 6 months and 12 months post-quit to assess smoking status.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •generally healthy
- •intact intellectual functioning (K-BIT2 >79)
- •smoking at least 5 cigarettes per day
- •expired CO concentration of at least 8 ppm or urinary cotinine > 100 ng/mL
- •interested in quitting smoking
排除标准
- •inability to attend all experimental sessions
- •report of significant health problems
- •use of psychoactive medications or current participation in psychotherapy
- •current unstable psychiatric illness as assessed by clinical diagnostic interview
- •suicidal ideation with plan or intent
- •regular use of smokeless tobacco
- •current alcohol or drug abuse
- •use of illegal drugs (excluding marijuana) as measured by urine drug screen
- •current use of nicotine replacement therapy or other smoking cessation treatment
- •presence of contraindications for nicotine replacement therapy
- •left-handed
- •presence of conditions that would make MRI unsafe
- •claustrophobia
- •history of fainting
- •pregnant, trying to become pregnant, or breastfeeding
研究组 & 干预措施
BA + VLNC
Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during the quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus behavioral activation therapy aimed at increasing reinforcement from non-drug rewards.
干预措施: Nicotine Patch (Drug)
BA + VLNC
Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during the quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus behavioral activation therapy aimed at increasing reinforcement from non-drug rewards.
干预措施: SPECTRUM Nicotine Research Cigarettes (.03 mg) (Drug)
BA + VLNC
Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during the quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus behavioral activation therapy aimed at increasing reinforcement from non-drug rewards.
干预措施: Behavioral Activation (Behavioral)
VLNC Only
Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus supportive counseling and health education.
干预措施: Nicotine Patch (Drug)
VLNC Only
Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus supportive counseling and health education.
干预措施: SPECTRUM Nicotine Research Cigarettes (.03 mg) (Drug)
VLNC Only
Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus supportive counseling and health education.
干预措施: Supportive Counseling (Behavioral)
结局指标
主要结局
Change in BOLD (Blood-oxygen-level-dependent) Response to Smoking Reward
时间窗: baseline, week 5
Effects of BA+VLNC (vs. VLNC Only) on pre-quit changes in fMRI BOLD response to smoking reward anticipation. BOLD signal change is estimated from the contrast of smoking reward anticipation vs neutral anticipation, and extracted from voxels within the ventral striatum at each time point.
Number of Participants Who Relapsed or Are Presumed to Have Relapsed
时间窗: weeks 6 to 13
Relapse is defined as return to 7 consecutive days of smoking.
Change in BOLD (Blood-oxygen-level-dependent) Response to Monetary Reward
时间窗: baseline, week 5
Effects of BA+VLNC (vs. VLNC Only) on pre-quit changes in fMRI BOLD response to monetary reward anticipation. BOLD signal change is estimated from the contrast of monetary reward anticipation vs neutral anticipation, and extracted from voxels within the ventral striatum at each time point.
次要结局
未报告次要终点
研究者
Maggie M Sweitzer, PhD
Assistant Professor
Duke University