CTRI/2011/091/000118已完成2 期
Efficacy of Varenicline for Smokeless Tobacco Use in India
ational Institute on Drug Abuse R DA0 个研究点目标入组 237 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 237
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •) Males and females over age 18 who have used smokeless tobacco every day for the past year (confirmed with urinary cotinine);
- •b) Residing within 100 km of New Dehli for the next 4 months
- •c) Interested in quitting use of smokeless tobacco.
排除标准
- •Participants will be ineligible for the trial if they:
- •1) are currently enrolled or plan to enroll in another tobacco cessation program in the next 4 months;
- •2)plan to use other smoking cessation treatments in the next 4 months;
- •3) smoke cigarettes bidi
- •4) have current substance abuse (e.g., opioids, cocaine, marijuana) verified by urine drug screen;
- •5) have current (last 6-months) alcohol consumption that exceeds 25 standard drinks/week (if past abuse, must be symptom free for ââ?°Â¥ the past 12 months);
- •6) Current use or discontinuation within last 14 days of:
- •a.smoking cessation medications (bupropion, Chantix, NRT);
- •b.antipsychotics, atypicals, mood-stabilizers, anti-depressants (tricyclics, SSRIs, MAOIs), anti-panic agents, anti-obsessive agents, anti-anxiety agents, stimulants;
- •c.Anti-coagulants;
- •d.Daily medication for asthma or diabetes (eligible with physician approval);
- •7) are pregnant, planning a pregnancy, or lactating;
- •8) have a history or current diagnosis of psychosis, bipolar disorder, or schizophrenia;
- •9) have a current diagnosis of depression (if past diagnosis, must be symptom free for ââ?°Â¥ the past 12 months); or generalized anxiety disorder
- •10) have an allergy to Varenicline
- •11) ever contemplated or attempted suicide;
- •12) have serious/unstable disease within the past 6 months (e.g., cancer [but melanoma], heart disease, HIV/AIDS);
- •13) have a history of epilepsy or seizure disorder;
- •14) have a history or diagnosis within the last 6 months of abnormal rhythms and/or tachycardia (100 beats/minute);
- •15) have a history or current diagnosis of COPD; cardiovascular disease (stroke, angina); heart attack in the last 6 months; and/or uncontrolled hypertension (SBP150 or DBP90);
- •16) have a history of kidney or liver failure;
- •17) have any medical condition or medication that could compromise safety as determined by a study physician; and
- •18) cannot provide informed consent or complete the study tasks as determined by the Principal Investigator or study physician.
研究者
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