Clinical trial NCT04560595: Remote Guided Caffeine Reduction
Official title: Remote Guided Caffeine Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Keywords: caffeine
caffeine reduction
online study
manualized treatment
caffeine fading
remote intervention
remote trial
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-09-23
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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 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: 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.

Eligibility 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 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 \[many psychiatric or medical concerns such as insomnia or anxiety are not anticipated to interfere with study participation and will not generally be exclusionary\]

Primary outcomes:
measure: Number of Participants With Treatment Retention as Assessed by Number of Participants With Completed Assessments
timeFrame: Treatment Visit, 7-Week Follow-Up, 14-Week Follow-Up
measure: Treatment Acceptability as Assessed by Treatment Acceptability Questionnaire
timeFrame: 7 weeks Follow-Up visit
Secondary outcomes:
measure: Change in Caffeine Consumption (in Milligrams)
timeFrame: Baseline, Treatment Visit, 7-Week Follow-Up, 14-Week Follow-Up
measure: Change in Caffeine-related Problems as Assessed by Past-7 Days Standardized Items
timeFrame: Baseline, 7-Week Follow-Up, 14-Week Follow-Up
measure: Change in Anxiety as Assessed by the PROMIS-Anxiety-8a
timeFrame: Baseline, 7-Week Follow-Up, 14-Week Follow-Up
measure: Change in Anxiety as Assessed by the GAD-7
timeFrame: Baseline, 7-Week Follow-Up, 14-Week Follow-Up
measure: Change in Sleep Problems as Assessed by the PROMIS Sleep Disturbance 8a
timeFrame: Baseline, 7-Week Follow-Up, 14-Week Follow-Up
measure: Change in Sleep Problems as Assessed by the PSQI
timeFrame: Baseline, 7-Week Follow-Up, 14-Week Follow-Up
measure: Change in Gastrointestinal Problems as Assessed by the PROMIS Reflux-13a
timeFrame: Baseline, 7-Week Follow-Up, 14-Week Follow-Up
measure: Change in Gastrointestinal Problems as Assessed by the GSRS
timeFrame: Baseline, 7-Week Follow-Up, 14-Week Follow-Up
measure: Change in Gastrointestinal Problems as Assessed by the PROMIS Diarrhea-6a
timeFrame: Baseline, 7-Week Follow-Up, 14-Week Follow-Up
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Dustin Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References: