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临床试验/NCT01951872
NCT01951872已完成不适用

Treatment for Caffeine Dependence

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2013年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
2
主要终点
Change in self-reported caffeine use

研究概览

简要总结

Recent research has shown that some individuals become addicted to or dependent on caffeine and are unable to quit or reduce caffeine consumption despite a persistent desire to do so. The aims of the current study are to characterize caffeine use among individuals with physical or psychological dependence on caffeine and evaluate a manual-based intervention to promote caffeine reduction and cessation.

详细描述

A large percentage of caffeine users in the general population (56%) report a persistent desire or unsuccessful efforts to stop or reduce caffeine consumption. The aim of Study 1 is to recruit and identify individuals who are interested in receiving treatment to reduce or quit caffeine consumption. Individuals will be recruited from Baltimore, MD and surrounding communities via flyers and newspaper and radio advertisements. Those who are eligible will be invited to come to the Behavioral Pharmacology Research Unit located on the Johns Hopkins Bayview Medical Center campus in Baltimore, MD. After consent is obtained at intake (consent form A), a series of questionnaires will be completed (e.g., demographics, caffeine history, medical and psychiatric history, mood), followed by a structured clinical interview that will assess caffeine use and dependence. Individuals who meet eligibility criteria will be offered the opportunity to receive assistance to reduce or quit caffeine. Those who consent (consent form B) to enroll in the second phase of the project will be randomly assigned to one of two conditions: 1) immediate treatment or 2) delayed treatment. The conditions will be identical with the exception of a 6 week delay for the delayed treatment group. Participants will receive a caffeine reduction and cessation treatment manual during a brief treatment session at week 1. Treatment progress will be assessed during a study session approximately 7 weeks post-treatment, during a telephone interview approximately 8 weeks post-treatment, and during a follow-up telephone call approximately 27 weeks after the treatment session. Progress will be assessed via questionnaires, food diaries, and salivary caffeine measures.

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
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Medically healthy
  • Self-reported problem with caffeine use
  • Moderate to heavy caffeine use

排除标准

  • Pregnancy
  • Current dependence on alcohol or illicit drugs

研究组 & 干预措施

Immediate treatment

Experimental

Immediate manual-based treatment for caffeine dependence: administered within approximately one week following intake.

干预措施: Manual-based treatment for caffeine dependence (Behavioral)

Delayed treatment

Experimental

Delayed manual-based treatment for caffeine dependence: administered within approximately six weeks following intake.

干预措施: Manual-based treatment for caffeine dependence (Behavioral)

结局指标

主要结局

Change in self-reported caffeine use

时间窗: Measure will be assessed at weeks 1, 7, 8, and 27.

次要结局

  • Change in biological measure of caffeine use(Measure will be assessed at weeks 1 and 7.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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