Remote Guided Caffeine Reduction

• ClinicalTrials.gov Identifier: NCT04560595
• Recruitment Status: Recruiting
• First Posted: September 23, 2020
• Last Update Posted: October 21, 2021
• Sponsor: Johns Hopkins University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

Brief Summary:

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 the 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.

Condition or disease	Intervention/treatment	Phase
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	Behavioral: Caffeine Reduction Manual	Not Applicable

Detailed Description:

There is emerging evidence that some individuals have difficulty cutting down or eliminating individual's 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 the 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 participants' personal characteristics including demographic information, weekly caffeine consumption, and general medical history. Participants who are determined to be eligible after screening will complete a session during which 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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 36 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Caffeine consumption and secondary measures will be examined before, during, and after the caffeine reduction intervention.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Remote Guided Caffeine Reduction
• Actual Study Start Date: September 10, 2020
• Estimated Primary Completion Date: June 2023
• Estimated Study Completion Date: August 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Caffeine Reduction Manual; 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.	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 Name: Johns Hopkins Guide to Caffeine Reduction and Cessation

Outcome Measures

Primary Outcome Measures :

1. Treatment adherence as assessed by percentage of completed assessments [ Time Frame: Up to 14 weeks post-intervention visit ]
   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.
2. Treatment acceptability as assessed by treatment acceptability questionnaire [ Time Frame: At 7 weeks post-intervention visit ]
   At the 7 Weeks Follow-Up video visit, we will use an internally-developed standardized treatment acceptability questionnaire to determine as well as self-reported agreement with the items on the treatment acceptability survey (e.g., "Overall, was the Guide to Caffeine Reduction and Cessation easy to use?"; "Overall, was the guide to Caffeine reduction and Cessation helpful?"). Acceptability questions are scored from 0-3 where lower scores indicate less acceptability (e.g., 0=not at all easy, not at all helpful; 3 = very easy, very helpful).

Secondary Outcome Measures :

1. Change in caffeine consumption (in milligrams) [ Time Frame: Baseline, at the time of intervention visit (within 1-2 weeks of screening), at 7 weeks post-intervention visit, at 14 weeks post-intervention visit ]
   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-and 14-week post-treatment follow-ups and compare this with consumption at the screening and treatment televisits. Based on participant responses to the number, type, and amount of caffeinated beverages, caffeine consumption is calculated at each assessment in milligrams (mg).
2. Change in caffeine-related problems as assessed by past-7 days standardized items [ Time Frame: Baseline, at the time of intervention visit (within 1-2 weeks of screening), at 7 weeks post-intervention visit, at 14 weeks post-intervention visit ]
   To determine to what extent participants report improvement in common caffeine-related problems following the remote intervention, we have developed a standardized 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. Higher sum scores on the measure indicate greater caffeine-related problems.
3. Change in anxiety as assessed by the PROMIS-Anxiety-8a [ Time Frame: Baseline, at the time of intervention visit (within 1-2 weeks of screening), at 7 weeks post-intervention visit, at 14 weeks post-intervention visit ]
   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). Higher scores reflect greater anxiety.
4. Change in anxiety as assessed by the GAD-7 [ Time Frame: Baseline, at the time of intervention visit (within 1-2 weeks of screening), at 7 weeks post-intervention visit, at 14 weeks post-intervention visit ]
   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 where higher scores indicate greater anxiety related symptoms.
5. Change in sleep problems as assessed by the PROMIS Sleep Disturbance 8a [ Time Frame: Baseline, at the time of intervention visit (within 1-2 weeks of screening), at 7 weeks post-intervention visit, at 14 weeks post-intervention visit ]
   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). Higher scores reflect greater sleep disturbance.
6. Change in sleep problems as assessed by the PSQI [ Time Frame: Baseline, at the time of intervention visit (within 1-2 weeks of screening), at 7 weeks post-intervention visit, at 14 weeks post-intervention visit ]
   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 for different components where a score of 0 indicates no difficulty and a score of 3 indicates severe difficulty. Higher global scores indicate greater sleep difficulties.
7. Change in gastrointestinal problems as assessed by the PROMIS Reflux-13a/Diarrhea-6a [ Time Frame: Baseline, at the time of intervention visit (within 1-2 weeks of screening), at 7 weeks post-intervention visit, at 14 weeks post-intervention visit ]
   To determine whether caffeine reduction is accompanied by a reduction in gastrointestinal problems, we will utilize the PROMIS Reflux-13a/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). Higher scores reflect greater gastrointestinal problems.
8. Change in gastrointestinal problems as assessed by the GSRS [ Time Frame: Baseline, at the time of intervention visit (within 1-2 weeks of screening), at 7 weeks post-intervention visit, at 14 weeks post-intervention visit ]
   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) and where higher scores indicate more severe gastrointestinal symptoms.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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 smartphone, 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]

Contacts and Locations

Contacts

Contact: Breanna Labos, MS; 410-550-1927; blabos1@jhmi.edu

Contact: Mary M Sweeney, PhD; 410-550-3076; marymsweeney@jhmi.edu

Locations

United States, Maryland

Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center; Recruiting

Baltimore, Maryland, United States, 21224

Contact: Breanna Labos, MSc 410-550-1927 blabos1@jhmi.edu

Principal Investigator: Mary M Sweeney, PhD

Sub-Investigator: Roland R Griffiths, PhD

Sponsors and Collaborators

Johns Hopkins University

National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Mary M Sweeney, PhD; Johns Hopkins University

More Information

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT04560595
• Other Study ID Numbers: IRB00250925; R01DA003890 ( U.S. NIH Grant/Contract )
• First Posted: September 23, 2020
• Last Update Posted: October 21, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: There is not currently a plan to make individual participant data available to other researchers.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:

caffeine; caffeine reduction; online study; manualized treatment; caffeine fading; remote intervention; remote trial

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Parasomnias; Dyssomnias; Disease; Diarrhea; Heartburn; Anxiety Disorders; Pathologic Processes; Mental Disorders; Sleep Disorders, Intrinsic; Nervous System Diseases; Signs and Symptoms, Digestive; Neurologic Manifestations; Caffeine; Central Nervous System Stimulants; Physiological Effects of Drugs; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Purinergic P1 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Neurotransmitter Agents