Assessment and Treatment of Caffeine Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00338195
Recruitment Status : Completed
First Posted : June 20, 2006
Last Update Posted : March 7, 2013
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Roland Griffiths, Johns Hopkins University

Brief Summary:

Recent research has established that some individuals report that they are unable to cease caffeine use, despite feeling that caffeine is posing a health risk or causing significant impairment in their daily activities. Despite the high rates of unsuccessful efforts to cease or control caffeine use in the population, there has been little research on the parameters of successful caffeine reduction and no research on caffeine cessation.

The goals of the study are as follows:

  1. evaluate the applicability of DSM-IV dependence criteria for self-reported problematic caffeine use.
  2. evaluate characteristics (e.g, co-morbid psychopathology) of individuals who report that they have had difficulty quitting caffeine use on their own and who are seeking treatment for caffeine use.
  3. test the efficacy of a caffeine reduction treatment administered to individuals who would like to quit/reduce caffeine use, but have found it difficult to do so in the past.

Condition or disease Intervention/treatment Phase
Self-identified Problematic Caffeine Use DSM-IV Substance Dependence as Applied to Caffeine Behavioral: Individualized caffeine cessation instructions Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2001
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Delayed intervention control Behavioral: Individualized caffeine cessation instructions
Intervention is described in the protocol

Primary Outcome Measures :
  1. self-reported caffeine use [ Time Frame: as described in protocol ]

Secondary Outcome Measures :
  1. biological measures of caffeine use [ Time Frame: as described in protocol ]
  2. mood questionnaires [ Time Frame: as described in protocol ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Consume >100mg caffeine per day
  2. 18-65 years old
  3. Medically healthy
  4. Self-reported problem with caffeine use.

Exclusion Criteria:

  1. Pregnancy
  2. Current dependence on alcohol or illicit drugs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00338195

United States, Maryland
Behavioral Biology Research Center, Johns Hopkins Bayview
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Roland R Griffiths, Ph.D. Professor, Johns Hopkins University School of Medicine

Additional Information:
Responsible Party: Roland Griffiths, Professor, Department of Psychiatry, Johns Hopkins University Identifier: NCT00338195     History of Changes
Other Study ID Numbers: BPR01-05-04-03
R01DA001147 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: March 7, 2013
Last Verified: March 2013

Keywords provided by Roland Griffiths, Johns Hopkins University:
Caffeine dependence
Caffeine withdrawal

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
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