Smoking Cessation Treatment for Methadone Maintenance Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.
研究概览
简要总结
Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.
详细描述
Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age 18 or older
- •English speaking
- •Smoked at least 100 cigarettes/lifetime
- •Smokes 5 or more cigarettes per day
- •Interested in quitting smoking (preparation or contemplation state of change)
- •Enrolled in Einstein/Montefiore methadone program for 3 or more months
- •Stable methadone dose for 2 weeks
- •Agree to use contraception throughout the trial (among women with reproductive potential)
- •Willing to participate in all study components
- •Able to provide informed consent
排除标准
- •Serious or unstable HIV/AIDS, liver, cardiovascular, or pulmonary disease
- •Psychiatric instability
- •Women who are pregnant, breastfeeding, or contemplating pregnancy
- •Creatinine clearance less than 30 mL/min
研究组 & 干预措施
Varenicline
Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
干预措施: Varenicline (Drug)
Placebo
Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
干预措施: Placebo (Drug)
结局指标
主要结局
Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.
时间窗: Week 12
次要结局
- Number of Study Visits Completed(24 weeks)
- 7-day Point Prevalence Abstinence at 12 Weeks as Verified by Salivary Cotinine.(Weeks 2, 4, 8, 12, and 24)
- Number of Cigarettes Smoked Per Day(Weeks 2, 4, 8, 12, and 24)
- Adverse Medication Effects(over the intervention period (measured at weeks 2, 4, 8, 12, and 24))
- Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview(over the intervention period (measured at weeks 2, 4, 8, 12, and 24))
- Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview(over the intervention period (measured at weeks 2, 4, 8, 12, and 24))
- Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.(Week 24)
- Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours(Weeks 2, 4, 8, 12, and 24)
- Importance of Quitting Smoking (1-10 Scale)(Weeks 2, 4, 8, 12, and 24)
- Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory(over the intervention period (measured at weeks 2, 4, 8, 12, and 24))
- Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview(over the intervention period (measured at weeks 2, 4, 8, 12, and 24))
- Confidence in Quitting Smoking (1-10 Scale)(Weeks 2, 4, 8, 12, and 24)
- Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale(over the intervention period (measured at weeks 2, 4, 8, 12, and 24))
- Number of Counseling Visits Completed(End of 12 week intervention period)