Mobile Contingency Management for Concurrent Abstinence From Cannabis and Cigarette Smoking: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Number of Participants Who Report Smoking Abstinence and Abstinence is Bioverified by Salivary Cotinine
研究概览
简要总结
The purpose of this pilot project is to pilot-test a combined cannabis and smoking cessation treatment. The intervention combines mobile technology with behavioral strategies, counseling, and medications.
详细描述
Cannabis is the most widely used illicit drug in the United States with 19.8 million current users. Population based data indicate that almost all cannabis users (90%) have a lifetime history of tobacco smoking and the majority (74%) currently smoke tobacco. While cannabis use alone is associated with significant adverse health effects, tobacco smoking is the number one preventable cause of illness and death in the U.S. This is true even among those using illicit drugs where the tobacco -related mortality rate is twice that of the general population. Among cannabis users, smoking tobacco is associated with increased frequency of marijuana use, increased morbidity, and poorer cannabis cessation outcomes. There is strong evidence for the short -term efficacy for cannabis use disorder (CUD) and smoking of contingency management (CM). It is an intensive behavioral therapy that provides incentives (vouchers, money) to individuals misusing substances contingent upon objective evidence from drug use. Implementation of CM has been limited because of the need to verify abstinence multiple times daily using clinic based monitoring and effects are short lived. The investigators recently developed a smart -phone application which allows a patient to video themselves several times daily while using a small CO monitor and to transmit the data to a secure server which has made the use of CM for outpatient smoking cessation portable and feasible. The mobile CM (mCM) approach paired with cognitive-behavioral counseling and pharmacological smoking cessation aids has been effective in reducing smoking in the short and long-term. The purpose of this pilot project is to pilot-test a combined cannabis and smoking mCM intervention. The pilot will allow the investigators to examine feasibility of the treatment and of planned recruitment strategies. These project aims will provide the first step toward implementation of an innovative approach that builds upon the power of mHealth technology to reduce the prevalence of both CUD and cigarette smoking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •report 40 or more days of cannabis use in the past 90 day;
- •have smoked at least seven cigarettes in the past seven days;
- •have been smoking for at least the past year;
- •can speak and write fluent conversational English;
- •are between 18 and 70 years of age; and
- •are willing to make an attempt to quit both cannabis and tobacco smoking.
排除标准
- •expected to have unstable medication regimen during the study;
- •currently receiving non-study behavioral treatment for cannabis use disorder or smoking;
- •myocardial infarction in past six months;
- •contraindication to NRT with no medical clearance;
- •use of other forms of nicotine such as cigars, pipes, or chewing tobacco with unwillingness to stop use of these forms;
- •current pregnancy;
- •primary psychotic disorder or current manic episode;
- •substance use disorder (other than cannabis or nicotine) within the preceding three months; or
- •current imprisonment or psychiatric hospitalization.
研究组 & 干预措施
Treatment
Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.
干预措施: bupropion (Drug)
Treatment
Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.
干预措施: transdermal nicotine patch (Drug)
Treatment
Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.
干预措施: Nicotine polacrilex (Drug)
Treatment
Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.
干预措施: nicotine lozenge (Drug)
Treatment
Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.
干预措施: counseling for marijuana and smoking cessation (Behavioral)
Treatment
Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.
干预措施: mobile contingency management (Behavioral)
结局指标
主要结局
Number of Participants Who Report Smoking Abstinence and Abstinence is Bioverified by Salivary Cotinine
时间窗: 6 month follow up
Self-reported abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence.
Number of Participants Who Report Marijuana Abstinence and Abstinence is Bioverified by Oral Fluid
时间窗: 6 month follow up
Self-reported abstinence (primary outcome) will be verified by oral fluid (OF) cannabis assessment. Oral fluid samples will be collected from participants who self-report prolonged abstinence.
Number of Participants Who Self-report Prolonged Abstinence From Smoking
时间窗: 6 month follow up
Participants self-report smoking behavior since smoking quit date. Prolonged abstinence is defined as sustained abstinence since two weeks post-initial smoking quit date.
Number of Participants Who Self-report Prolonged Abstinence From Marijuana Use
时间窗: 6 month follow up
Participants self-report marijuana use since marijuana quit date. Prolonged abstinence is defined as sustained abstinence since two weeks post-initial quit date.
次要结局
- Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking(6 month follow up)
- Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Marijuana(6 month follow up)
- Number of Participants Who Report 7 Day Point Prevalence Abstinence From Marijuana(3 month follow up)
- Number of Participants Who Report 30 Day Point Prevalence Abstinence From Marijuana(6 month follow up)
- Number of Voluntary Withdrawals From the Project(Evaluated at 6 month follow-up)
- Proportional Change in Days Smoked From Pre-quit to 6-month Follow up (for Entire Group)(30 days prior to quit date, 6 month follow up)
- Percentage of Missing Mobile Contingency Management Video Recordings(3 month follow up)
- Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking(6 month follow up)
- Number of Participants Who Report 7 Day Point Prevalence Abstinence From Smoking(3 month follow up)
- Number of Participants Who Report Smoking Abstinence and Abstinence is Bioverified by Salivary Cotinine(3 month follow up)
- Change From Baseline in Number of Days Per Week of Cannabis Use(baseline, 6 month follow up)
- Change in Number of Cigarettes Smoked Per Week Compared to Pre-quit(7 days prior to quit date, 6 month follow up)
- Number of Missed Behavioral Counseling Sessions(3 month follow up)
- Number of Participants Who Report Marijuana Abstinence and Abstinence is Bioverified by Salivary Cotinine(3 month follow up)
- Proportional Change in Days of Cannabis Use From Pre-quit to 6 Month Follow-up (Entire Group)(30 days prior to quit date, 6 month follow up)