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Assessment and Treatment of Caffeine Dependence
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), November 2008
Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00338195
  Purpose

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 Intervention Phase
Self-Identified Problematic Caffeine Use
DSM-IV Substance Dependence as Applied to Caffeine
Behavioral: Individualized caffeine cessation instructions
Phase I

MedlinePlus related topics: Caffeine
Drug Information available for: 3,7-Dihydro-1,3,7-trimethyl-1H-purine-2,6-dione Caffeine citrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • self-reported caffeine use [ Time Frame: as described in protocol ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • biological measures of caffeine use [ Time Frame: as described in protocol ] [ Designated as safety issue: No ]
  • mood questionnaires [ Time Frame: as described in protocol ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: May 2001
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Individualized caffeine cessation instructions
    Intervention is described in the protocol
Detailed Description:

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.

Individuals will be recruited from the community via flyers, newspaper and radio advertisements. Those who are eligible will be invited to come to the Behavioral Pharmacology Research Unit. After consent is obtained (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 which will assess for a caffeine dependence syndrome and other psychopathology, as defined by the DSM-IV.

Afterwards, individuals who meet criteria will be offered the opportunity to receive assistance to reduce or quit using 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 2. wait-list control treatment. The conditions will be identical with the exception of the 6 week delay for one group. The treatment will consist of a brief individual counseling session, individualized caffeine tapering instructions, and a take home booklet. Participants return to BPRU at 6 weeks, 12 weeks, and 26 weeks post treatment to complete follow-up assessments. Participants will be assessed via telephone at 2 weeks and 52 weeks post-treatment. Follow- up measures will consist of self-reported caffeine use, biological measures of caffeine exposure (saliva), mood, and withdrawal questionnaires, and circumstances surrounding lapse incidences.

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.

Risks and Benefits: The study procedures do not involve significant risk aside from the minor risk associated with a possible loss of confidentiality. Overall, this study will provide information about the occurrence of caffeine dependence syndrome as defined by the DSM-IV and the consumer demand for behavioral treatments for caffeine dependence. Furthermore, we will test a brief intervention for caffeine dependence. Presently there are no standard or empirically validated treatments for problematic caffeine use. Participants may benefit by receiving free assistance to reduce or cease their caffeine use. Society will benefit to the extent that successfully treating problematic caffeine use allows individuals to function more effectively.

Safety Monitoring: The principal investigator will review data any reports of untoward effects or possible adverse events.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00338195

Contacts
Contact: Roland R Griffiths, Ph.D. 410 550-0034 rgriff@jhmi.edu

Locations
United States, Maryland
Behavioral Biology Research Center, Johns Hopkins Bayview Recruiting
Baltimore, Maryland, United States, 21224
Principal Investigator: Roland R Griffiths, Ph.D.            
Sponsors and Collaborators
Investigators
Principal Investigator: Roland R Griffiths, Ph.D. Professor, Johns Hopkins University School of Medicine
  More Information

Information about caffeine dependence  This link exits the ClinicalTrials.gov site

Responsible Party: Johns Hopkins University School of Medicine ( Roland Griffiths )
Study ID Numbers: BPR01-05-04-03
Study First Received: June 15, 2006
Last Updated: November 20, 2008
ClinicalTrials.gov Identifier: NCT00338195  
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
Caffeine dependence
Caffeine withdrawal

Study placed in the following topic categories:
Caffeine citrate
Mental Disorders
Citric Acid
Substance-Related Disorders
Disorders of Environmental Origin
Caffeine

Additional relevant MeSH terms:
Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Stimulants
Enzyme Inhibitors
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009