Remote Guided Caffeine Reduction

January 10, 2025 updated by: Johns Hopkins University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
109

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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]

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: 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.
Other Names:
  • Johns Hopkins Guide to Caffeine Reduction and Cessation
Experimental: 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.
Behavioral: 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.
Other Names:
  • Johns Hopkins Guide to Caffeine Reduction and Cessation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment Retention as Assessed by Number of Participants With Completed Assessments
Time Frame: Treatment Visit, 7-Week Follow-Up, 14-Week Follow-Up
To determine to what extent participants will engage with a remote caffeine reduction intervention for caffeine-related problems and find it acceptable, we will calculate the percentage of completed assessments for each video visit among eligible participants.
Treatment Visit, 7-Week Follow-Up, 14-Week Follow-Up
Treatment Acceptability as Assessed by Treatment Acceptability Questionnaire
Time Frame: 7 weeks Follow-Up visit
At the 7 Weeks Follow-Up video visit, we will use an internally-developed standardized treatment acceptability questionnaire to determine self-reported agreement with two items on the treatment acceptability survey (i.e., "Overall, was the Guide to Caffeine Reduction and Cessation easy to use?", and "Overall, was the guide to Caffeine reduction and Cessation helpful?"). Each question is scored on a scale from 0-3, for a total score range of 0-6, where lower scores indicate less acceptability (e.g., 0=not at all easy, not at all helpful; 3 = very easy, very helpful).
7 weeks Follow-Up visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Caffeine Consumption (in Milligrams)
Time Frame: Baseline, Treatment Visit, 7-Week Follow-Up, 14-Week Follow-Up
To determine to what extent participants are successfully able to reduce their caffeine consumption following the remote intervention, we will assess caffeine consumption as determined by the standardized caffeine assessments at 7 week post-treatment follow-ups and compare this with consumption at the screening televisit. Based on participant responses to the number, type, and amount of caffeinated beverages, caffeine consumption is calculated at each assessment in milligrams (mg).
Baseline, Treatment Visit, 7-Week Follow-Up, 14-Week Follow-Up
Change in Caffeine-related Problems as Assessed by Past-7 Days Standardized Items
Time Frame: Baseline, 7-Week Follow-Up, 14-Week Follow-Up
To determine to what extent participants report improvement in common caffeine-related problems following the remote intervention, we have developed a standardized 19-Item Caffeine Use Disorder measure of the extent to which common problems related to excessive caffeine consumption bothered participants within the past 7 days, e.g., "During the past 7 days, I have consumed caffeine in larger amounts or over a longer period than I intended." Participants rate the extent to which these problems bothered them on a scale from 0-3 where 0 = not at all a problem and 3 = major problem. The total possible scale range is from 0-57 (because the scores of 0-3 are summed for the 19 items). Higher sum scores on the measure indicate greater caffeine-related problems.
Baseline, 7-Week Follow-Up, 14-Week Follow-Up
Change in Anxiety as Assessed by the PROMIS-Anxiety-8a
Time Frame: Baseline, 7-Week Follow-Up, 14-Week Follow-Up
To determine whether caffeine reduction is accompanied by a reduction in day-to-day anxiety, we will utilize the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 8a assessment. The questionnaire asks the extent to which anxiety-related items affected the participants over the past 7 days on a scale of 1 (never) to 5 (always) with a total raw score range of 8-40 in which higher scores reflect greater anxiety. Raw scores are then translated into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like anxiety, a T-score of 60 is one SD worse than average. By comparison, an anxiety T-score of 40 is one SD better than average. A score of less than 55 is none to slight, 55.0-59.9 is mild, 60.0-69.9 is moderate, and 70 and over is severe.
Baseline, 7-Week Follow-Up, 14-Week Follow-Up
Change in Anxiety as Assessed by the GAD-7
Time Frame: Baseline, 7-Week Follow-Up, 14-Week Follow-Up
To determine whether caffeine reduction is accompanied by a reduction in day-to-day anxiety, we will utilize the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 consists of items asking the participant to rate on a scale of 0 (not at all) to 3 (nearly every day) the extent they have experienced anxiety related symptoms. The scoring range is 0-21 and higher scores indicate greater anxiety related symptoms.
Baseline, 7-Week Follow-Up, 14-Week Follow-Up
Change in Sleep Problems as Assessed by the PROMIS Sleep Disturbance 8a
Time Frame: Baseline, 7-Week Follow-Up, 14-Week Follow-Up
To determine whether caffeine reduction is accompanied by a reduction in sleep problems, we will utilize the PROMIS Sleep Disturbance 8a assessment. The questionnaire asks the extent to which sleep-related items affected the participants over the past 7 days on a scale of 1 (not at all) to 5 (very much). The raw scoring range is 8-40 and higher scores reflect greater sleep disturbance. Raw scores are then translated into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like sleep disturbance, a T-score of 60 is one SD worse than average. By comparison, T-score of 40 is one SD better than average. A T-score of 50 or above is often considered a clinically significant level of sleep disturbance.
Baseline, 7-Week Follow-Up, 14-Week Follow-Up
Change in Sleep Problems as Assessed by the PSQI
Time Frame: Baseline, 7-Week Follow-Up, 14-Week Follow-Up
To determine whether caffeine reduction is accompanied by a reduction in sleep problems, we will utilize the Pittsburgh Sleep Quality Index (PSQI), which contains 19 self-rated items and 7 sub-scales for different components where a score of 0 indicates no difficulty and a score of 3 indicates severe difficulty. The scoring range is 0-21 and higher global scores indicate greater sleep difficulties.
Baseline, 7-Week Follow-Up, 14-Week Follow-Up
Change in Gastrointestinal Problems as Assessed by the PROMIS Reflux-13a
Time Frame: Baseline, 7-Week Follow-Up, 14-Week Follow-Up
To determine whether caffeine reduction is accompanied by a reduction in gastrointestinal problems, we will utilize the PROMIS Reflux-13a. These items ask the extent to which gastrointestinal-related items affected the participants over the past 7 days on a scale of 1 (never) to 5 (always). The scoring range of raw scores is 13-65 and higher scores reflect greater gastrointestinal problems. Raw scores are then translated into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like reflux, a T-score of 60 is one SD worse than average. By comparison, an anxiety T-score of 40 is one SD better than average.
Baseline, 7-Week Follow-Up, 14-Week Follow-Up
Change in Gastrointestinal Problems as Assessed by the GSRS
Time Frame: Baseline, 7-Week Follow-Up, 14-Week Follow-Up
To determine whether caffeine reduction is accompanied by a reduction in gastrointestinal problems, we will utilize the Gastrointestinal Symptoms Rating Scale (GSRS) which consists of 15 items describing gastrointestinal distress where responses range from 0 (no discomfort at all) to 6 (very severe discomfort). The scoring range is 0-90 and higher scores indicate more severe gastrointestinal symptoms.
Baseline, 7-Week Follow-Up, 14-Week Follow-Up
Change in Gastrointestinal Problems as Assessed by the PROMIS Diarrhea-6a
Time Frame: Baseline, 7-Week Follow-Up, 14-Week Follow-Up
To determine whether caffeine reduction is accompanied by a reduction in gastrointestinal problems, we will utilize the PROMIS Diarrhea-6a. These items ask the extent to which gastrointestinal-related items affected the participants over the past 7 days on a scale of 1 (never) to 5 (always). The raw scoring range is 6-30 and higher scores reflect greater gastrointestinal problems. Raw scores are then translated into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like diarrhea, a T-score of 60 is one SD worse than average. By comparison, an anxiety T-score of 40 is one SD better than average.
Baseline, 7-Week Follow-Up, 14-Week Follow-Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dustin Lee, PhD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00250925
  • R01DA003890 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not currently a plan to make individual participant data available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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