Assessment and Treatment of Caffeine Dependence

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roland Griffiths, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00338195
First received: June 15, 2006
Last updated: March 6, 2013
Last verified: March 2013
  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 1

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:


Further study details as provided by Johns Hopkins University:

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 ]

Enrollment: 94
Study Start Date: May 2001
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Delayed intervention control Behavioral: Individualized caffeine cessation instructions
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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Johns Hopkins University
Investigators
Principal Investigator: Roland R Griffiths, Ph.D. Professor, Johns Hopkins University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Roland Griffiths, Professor, Department of Psychiatry, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00338195     History of Changes
Other Study ID Numbers: BPR01-05-04-03, R01DA001147
Study First Received: June 15, 2006
Last Updated: March 6, 2013
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins University:
Caffeine dependence
Caffeine withdrawal

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced 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 September 18, 2014