CClinicalTrials.gg
CompletedNCT01951872Updated Aug 18, 2017

Treatment for Caffeine Dependence

An interventional study of Manual-based treatment for caffeine dependence in Caffeine Use Disorder (DSM-5 Condition for Further Study), sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-08-18.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Caffeine Use Disorder (DSM-5 Condition for Further Study)

Keywords

  • caffeine dependence
  • caffeine withdrawal
  • caffeine use disorder
03

In context

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Current dependence on alcohol or illicit drugs
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
82 participants (actual)

Study arms

  • Experimental
    Immediate treatment

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

    Behavioral: Manual-based treatment for caffeine dependence

  • Experimental
    Delayed treatment

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

    Behavioral: Manual-based treatment for caffeine dependence

Interventions

  • BehavioralManual-based treatment for caffeine dependence

    Participants will meet with a counselor to discuss plans for caffeine reduction or cessation, and they will receive a manual-based treatment to help guide them through caffeine reduction or cessation.

06

What researchers measure

Primary outcomes

  1. Change in self-reported caffeine use

    Time frame: Measure will be assessed at weeks 1, 7, 8, and 27.

Secondary outcomes

  1. Change in biological measure of caffeine use

    Salivary caffeine

    Time frame: Measure will be assessed at weeks 1 and 7.

07

Study locations

1 site
  • Behavioral Pharmacology Research Unit
    Baltimore, Maryland 21224, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01951872
Lead sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Sponsor
First posted
Sep 27, 2013
Start date
Sep 2013
Primary completion
Mar 2017
Completion
Mar 2017
Last update
Aug 18, 2017

Study contacts

Roland R Griffiths, PhD
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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