Remote Guided Caffeine Reduction

NCT ID: NCT04560595

Last Updated: 2025-01-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-10

Study Completion Date

2023-10-01

Brief Summary

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The purpose of this online research study is to determine whether or not a gradual caffeine reduction program developed at Johns Hopkins can help people reduce their caffeine use. The investigators will provide materials to help guide caffeine reduction and ask questions to track caffeine use over several weeks. The investigators will also assess how reducing caffeine may benefit common caffeine-related problems such as anxiety, sleep disturbances, and gastrointestinal distress. The study will also determine whether or not people like participating in this caffeine reduction program in an online format.

Detailed Description

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There is emerging evidence that some individuals have difficulty cutting down or eliminating caffeine consumption in spite of clinically significant problems exacerbated by caffeine use. This study will evaluate whether a caffeine reduction program developed at Johns Hopkins can help people reduce their caffeine use in an online format. Volunteers will participate in an intervention study conducted entirely online, including video visits for screening, instructions for caffeine reduction, and follow up. The study also involves filling out online surveys sent via email and text message. During screening, participants will be asked questions about their personal characteristics including demographic information, weekly caffeine consumption, and general medical history. Participants who are determined to be eligible after screening will be randomized to either the immediate or delayed treatment group. Those in the immediate treatment group will have their next session immediately after screening while those in the delayed treatment group will have their next session 7 weeks after screening. At this session, participants receive a digital copy of a caffeine reduction manual and instructions on how to gradually cut down caffeine. After this, participants will complete weekly online surveys over six weeks. Participants will complete two follow-up video visits at 7 and 14 weeks after participants received the caffeine reduction instructions. The investigators will measure caffeine consumption over time using the online surveys and interview questions during video visits, and the investigators will also measure how various caffeine related problems may improve during caffeine reduction, such as sleep problems, gastrointestinal issues, and anxiety. During the end of study sessions, participants will answer questions related to acceptability of the online format and report on participants' current caffeine use.

Conditions

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Caffeine Dependence Anxiety Sleep Disturbance Gastrointestinal Dysfunction Sleep Initiation and Maintenance Disorders Caffeine; Sleep Disorder Caffeine Caffeine-Induced Anxiety Disorder Caffeine Withdrawal Caffeine-Induced Sleep Disorder, Without Use Disorder Caffeine Abuse Insomnia Anxiety Disorders Sleep Disorder Heartburn Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Caffeine consumption and secondary measures will be examined before, during, and after the caffeine reduction intervention and compared between immediate and delayed treatment groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Caffeine Reduction Manual, Immediate Treatment Group

Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the immediate treatment group will receive the guide immediately after screening.

Group Type EXPERIMENTAL

Caffeine Reduction Manual

Intervention Type BEHAVIORAL

We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.

Caffeine Reduction Manual, Delayed Treatment Group

Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the delayed treatment group will receive the guide seven weeks after screening.

Group Type EXPERIMENTAL

Caffeine Reduction Manual

Intervention Type BEHAVIORAL

We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.

Interventions

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Caffeine Reduction Manual

We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.

Intervention Type BEHAVIORAL

Other Intervention Names

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Johns Hopkins Guide to Caffeine Reduction and Cessation

Eligibility Criteria

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Inclusion Criteria

* 18-75 years old
* Reside in the United States
* Read, write, and speak English fluently
* Able to access a video camera on a smart phone, tablet, or other computer
* Able to receive text messages or emails (or both)
* Suitable caffeine consumption
* Indicate suitable reason for caffeine reduction
* Interested in getting help to gradually reduce or eliminate caffeine consumption as part of a research study

Exclusion Criteria

* Any current medical or psychiatric disorder or symptoms that, in the opinion of the investigators, may interfere with or preclude completion of the study \[many psychiatric or medical concerns such as insomnia or anxiety are not anticipated to interfere with study participation and will not generally be exclusionary\]
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dustin Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01DA003890

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00250925

Identifier Type: -

Identifier Source: org_study_id

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