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临床试验/NCT02042521
NCT02042521已完成2 期

A Dietary Supplement for Early Cigarette Withdrawal

Centre for Addiction and Mental Health1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
21
试验地点
1
主要终点
Change in the Visual Analog Scale as Compared to Baseline Compared Across Two Conditions

研究概览

简要总结

The purpose of this study is to determine whether a dietary supplement (DS) is effective in protecting against sad mood during early cigarette withdrawal. This study will also assess whether the dietary supplement will be well tolerated during early cigarette withdrawal.

详细描述

100 subjects who smoke at least 20 cigarettes per day will come in on two different days, at least one week apart, in a randomized, double blind, within subject, placebo controlled design. On each day subjects will refrain from smoking cigarettes for 8 hours. On one day subjects will take the active DS (taken in two doses, the evening dose is taken at 22:00 of the night before the test day and the morning dose is taken at 8:00 of the test day) and on the other day subjects will take placebo (also taken in two doses at the same time points of the active DS). Mood symptoms and symptoms of cigarette withdrawal will be compared across the two different days. Measures of mood symptom monitoring will include self report on a scale of 1 to 10, standardized rater questions about mood, and 6 hours into withdrawal, a standardized mood induction will be done with mood assessment. Symptoms of cigarette withdrawal will be assessed over the duration of withdrawal with applied standardized rating scales by trained raters. For the first 15 - 30 subjects, on each day, a health assessment of a physical exam and blood work will be completed at the end of the withdrawal period on both test days as well as for the initial assessment appointment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • males and females
  • age 18-65
  • generally good physical health
  • not using any illicit substances
  • smoke on average at least 20 cigarettes/day.

排除标准

  • Recent history of myocardial infarction and / or stroke
  • active substance abuse except for nicotine and active fluctuant medical conditions. (present and ongoing within 3 months)
  • Score of higher than 7 on the 17- item Hamilton Depression Rating Scale
  • Positive results for the pregnancy testing done on the first assessment visit.
  • A specific allergy to fruit-based ingredient.

研究组 & 干预措施

Healthy Smokers (Active then Placebo)

Experimental

Healthy individuals who smokes at least 20 cigarettes per day

Interventions: Dietary Supplement, Lactose Placebo

干预措施: Dietary Supplement (Drug)

Healthy Smokers (Active then Placebo)

Experimental

Healthy individuals who smokes at least 20 cigarettes per day

Interventions: Dietary Supplement, Lactose Placebo

干预措施: Lactose Placebo (Drug)

Healthy Smokers (Placebo then Active)

Experimental

Healthy individuals who smokes at least 20 cigarettes per day

Interventions: Dietary Supplement, Lactose Placebo

干预措施: Dietary Supplement (Drug)

Healthy Smokers (Placebo then Active)

Experimental

Healthy individuals who smokes at least 20 cigarettes per day

Interventions: Dietary Supplement, Lactose Placebo

干预措施: Lactose Placebo (Drug)

结局指标

主要结局

Change in the Visual Analog Scale as Compared to Baseline Compared Across Two Conditions

时间窗: Two sessions at least one week apart

VAS uses a 10-cm scale for participants to indicate the extent to which each of them feel happy or sad. The change in VAS before versus after sad mood induction is the change score in VAS. The change score on the day with active dietary supplement is compared to the change score on the day with the placebo dietary supplement.

次要结局

  • Potential Side Effects Questionnaire(Twice on both test days: once in the morning right before the morning active or placebo dietary supplement and once more right after the observed break)
  • Profile of Mood States(Anytime during initial assessment visit. On both test days, at least 1 week apart at: (7:35-8:00); (8:40-9:05); (11:20-11:45); (12:25-12:50); (13:10-13:30); (14:30-14:55))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeff Meyer

Program Head, Neurochemical Imaging for Mood Disorders

Centre for Addiction and Mental Health

研究点 (1)

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