Smoking Cessation & Opioid Dependence Treatment Integration: Does Timing Matter?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Recruitment, Assignment to Treatment, and Retention Rates
研究概览
简要总结
The primary purpose of this study was to examine the feasibility of integrating a smoking cessation intervention for cigarette smokers enrolled in an outpatient program for opioid dependence. The secondary purpose was to compare treatment effects as a function of phase in the outpatient program: 0-90 days (weekly attendance), 90 days-1 year (biweekly attendance), and more than 1 year (monthly attendance).
详细描述
Tobacco smoking rates are substantially higher among individuals with substance use disorders (SUDs), relative to individuals in the general population (e.g., 97% vs. 19%, respectively). Yet most treatment programs for SUDs fail to address the use of tobacco among patients, and integration of smoking cessation treatment with SUD treatment may improve outcomes for both drugs. The question remains, however, whether to implement a smoking cessation component immediately or only after a patient is stabilized on their SUD pharmacotherapy. Existing research that directly addresses this factor is limited and findings are mixed. Therefore, the purpose of this study was to compare drug use outcomes among patients at three different stages of their SUD treatment: 0-90 days (weekly clinic attendance), 90 days-1 year (biweekly clinic attendance), and more than 1 year (monthly clinic attendance) of consistent abstinence from illicit drugs. Smokers currently in treatment for opioid dependence, at the WVU Comprehensive Opioid Addiction Treatment (COAT) program, were recruited to participate in this 12-week study. Our goal was to complete 20 patients from each of the three COAT treatment groups. During the 12-week intervention period, individuals continued to attend their regular COAT clinic appointments while following a standard varenicline (Chantix®) dosing regimen and responding to questions daily via text messaging (e.g., adherence to varenicline, use of tobacco, tobacco withdrawal side effects, etc.). The primary outcomes are those relevant to feasibility: 1) recruitment, randomization, and retention, 2) adherence to medication regimen, and 3) compliance with responding to text message-based questions. Secondary outcomes include a comparison of the three COAT treatment groups on 1) relapses for all substances, 2) the proportion of smokers abstinent at each assessment (confirmed with expired air carbon monoxide samples), 3) days until successful cigarette quit day, 4) substance withdrawal and medication side effect symptoms, 5) motivation to quit tobacco, and 6) cigarette quit attempts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •enrolled in the Comprehensive Opioid Addiction Treatment (COAT) program
- •report smoking >10 cigarettes per day for >1 year
- •provide an expired air carbon monoxide (CO) reading of >10 parts/million (ppm)
- •report interest in making a quit attempt in the next 1-6 months (Contemplation or Preparation stages via the Stage of Change; Prochaska & Diclemente, 1983)
- •willing to try varenicline for smoking cessation
排除标准
- •current engagement in any form of tobacco cessation (e.g., pharmacotherapy)
- •current use of contraindicated medications (e.g., theophylline, warfarin, insulin)
- •Stage of Change category as Precontemplation (no plans to quit), Action (actively trying to quit), or Maintenance (have already quit)
- •self-reported seizures in the past year
- •untreated cardiovascular disease
- •self-report breast-feeding
- •pregnancy (verified by urinalysis)
- •not within 4 weeks of advancing to the next COAT group
研究组 & 干预措施
Weekly Opioid Tx
Participants in this group attended an outpatient opioid clinic once per week. As part of the current study, they received 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
干预措施: varenicline (Drug)
Biweekly Opioid Tx
Participants in this group attended an outpatient opioid clinic once bi-weekly. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
干预措施: varenicline (Drug)
Monthly Opioid Tx
Participants in this group attended an outpatient opioid clinic once per month. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
干预措施: varenicline (Drug)
结局指标
主要结局
Recruitment, Assignment to Treatment, and Retention Rates
时间窗: up to 12 weeks
For primary feasibility outcomes, recruitment, assignment to treatment, and retention rates were analyzed using descriptive statistics.
Percentage of Days on Which Participants Experienced Each Reason for Attrition
时间窗: up to 4 weeks
Drug withdrawal and medication side effect ratings were assessed as potential reasons for attrition. This assessment was completed by calculating the mean percentage of days, out of the first four weeks, during which effects were reported by participants who completed the entire 12-week protocol versus participants that dropped out. We limited this analysis to the first four weeks.
Number of Study Days With Protocol Non-Adherence
时间窗: up to 12 weeks
Medication non-adherence rates: The number of study days on which participants a) self-reported not taking the medication (i.e. provided a response of "no") or b) had a missing medication response (i.e. provided no response) via text message. Text-messaging non-adherence rates: The number of study days in which participants failed to respond to one or more assessments measured via text message.
Medication Acceptability for Completers
时间窗: up to 12 weeks
Side effect ratings of nausea, headache, sleep problems, gas/constipation, abnormal dreams, depressed mood, and drowsy; scores ranged from 0-10 and higher scores indicate more severe symptoms.
次要结局
- Cigarettes Smoked Per Day(up to 12 weeks)
- Number of Study Days Until First Cigarette Quit Attempt(up to 12 weeks)
- Number of Participants With Cigarette Smoking Quit Attempts and Actual Quit(Up to 12 weeks)
- Drug Withdrawal Ratings(up to 12 weeks)
- Expired Air Carbon Monoxide(up to 12 weeks)
- Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc)(up to 12 weeks)
- Readiness to Quit Smoking(up to 12 weeks)
- Number of Participants That Moved in Stage of Change for Quitting Smoking(up to 12 weeks)
研究者
Melissa Blank
Assistant Professor
West Virginia University