Efficacy of Varenicline for Smokeless Tobacco Use in India
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 237
- 试验地点
- 1
- 主要终点
- 7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment.
研究概览
简要总结
This study, based in India, is testing the efficacy of varenicline to help smokeless tobacco users with cessation efforts.
详细描述
The prevalence of smokeless tobacco use in the United States is low vs. cigarette smoking, yet rates have remained constant over the past few years. In contrast, the rate of smokeless tobacco use in India is 20%. Smokeless tobacco is a carcinogenic and responsible for ~10,000 deaths/year from oral cancer in India. Unfortunately, there have been remarkably few intervention trials in India for smokeless tobacco users. To date, no trial has evaluated the new FDA approved medication, varenicline, for smokeless tobacco use. We will conduct a randomized placebo-controlled trial of varenicline for smokeless tobacco dependence at the National Drug Dependence Treatment Center (NDDTC) at the All India Institute of Medicine (AIIMS) in New Delhi with 237 smokeless tobacco users. The primary aims of this trial are to: 1) enhance research capacity at the NDDTC (i.e., train AIIMS staff to implement the behavioral counseling protocol with pharmacotherapy, data collection and management procedures); 2) assess the efficacy of varenicline for increasing biochemically confirmed 7-day point prevalence smokeless tobacco quit rates at the end-of treatment; and 3) assess longitudinal patterns of relapse and recovery following treatment with varenicline. The results of this trial may guide future investments to evaluate the efficacy of varenicline for smokeless tobacco dependence in the US, which is critical since smokeless tobacco use in the US may increase in the coming years and no approved pharmacotherapy for this drug dependence exists in the US or around the globe.
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
- 是
入选标准
- •males and females
- •over age 18
- •used smokeless tobacco every day for the past year (confirmed with urinary cotinine)
- •residing within 100km of New Dehli for the next 4 months
- •interested in quitting use of smokeless tobacco.
排除标准
- •currently enrolled or plan to enroll in another tobacco cessation program in the next 4 months
- •plan to use other smoking cessation treatments in the next 4 months
- •smoke cigarettes
- •have current substance abuse (e.g., opioids, cocaine, marijuana) verified by urine drug screen
- •have current (last 6-months) alcohol consumption that exceeds 25 standard drinks/week (if past abuse, must be symptom free for ≥ the past 12 months)
- •Current use or discontinuation within last 14 days of:
- •smoking cessation medications (bupropion, Varenicline, NRT);
- •antipsychotics, atypicals, mood-stabilizers, anti-depressants (tricyclics, SSRIs, MAOIs), anti-panic agents, anti-obsessive agents, anti-anxiety agents, stimulants;
- •Anti-coagulants;
- •Daily medication for asthma or diabetes (eligible with physician approval);
- •are pregnant, planning a pregnancy, or lactating
- •have a history or current diagnosis of psychosis, general anxiety disorder,bipolar disorder, or schizophrenia
- •have a current diagnosis of depression (if past diagnosis, must be symptom free for ≥ the past 12 months)
- •have an allergy to Varenicline
- •ever contemplated or attempted suicide
- •have serious/unstable disease within the past 6 months (e.g., cancer [but melanoma], heart disease, HIV/AIDS)
- •have a history of epilepsy or seizure disorder
- •have a history or diagnosis within the last 6 months of abnormal rhythms and/or tachycardia (>100 beats/minute)
- •have a history or current diagnosis of COPD; cardiovascular disease (stroke, angina); heart attack in the last 6 months; and/or uncontrolled hypertension (SBP>150 or DBP>90)16)
- •have a history of kidney or liver failure
- •have any medical condition or medication that could compromise safety as determined by a study physician
- •cannot provide informed consent or complete the study tasks as determined by the Principal Investigator or study physician.
研究组 & 干预措施
Varenicline
干预措施: Varenicline (Drug)
Varenicline
干预措施: Counseling (Behavioral)
Placebo
干预措施: Counseling (Behavioral)
结局指标
主要结局
7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment.
时间窗: At the end of treatment (12 weeks)
次要结局
- Nicotine Withdrawal and Craving, Negative Affect, Positive Affect, and Side Effects.(Ongoing throughout the treatment period (Baseline to the end of treatment, 12 weeks))
研究者
Robert Schnoll
Associate Professor
University of Pennsylvania