Assessment and Treatment of Caffeine Dependence - Full Text View

Sponsor:	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:

evaluate the applicability of DSM-IV dependence criteria for self-reported problematic caffeine use.
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.
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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Caffeine

Drug Information available for: 3,7-Dihydro-1,3,7-trimethyl-1H-purine-2,6-dione

U.S. FDA Resources

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
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Intervention is described in the protocol

Show Detailed Description

Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Pregnancy
Current dependence on alcohol or illicit drugs.

Contacts and Locations

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

Locations

United States, Maryland
Behavioral Biology Research Center, Johns Hopkins Bayview
Baltimore, Maryland, United States, 21224

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Roland R Griffiths, Ph.D.

Professor, Johns Hopkins University School of Medicine

More Information

Additional Information:

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

No publications provided

Responsible Party:	Roland Griffiths, Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier:	NCT00338195 History of Changes
Other Study ID Numbers:	BPR01-05-04-03
Study First Received:	June 15, 2006
Last Updated:	December 16, 2009
Health Authority:	United States: Federal Government

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

Caffeine dependence
Caffeine withdrawal

Additional relevant MeSH terms:

Substance-Related Disorders
Mental Disorders
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on February 12, 2012