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Assessment and Treatment of Caffeine Dependence

Primary Purpose

Self-identified Problematic Caffeine Use, DSM-IV Substance Dependence as Applied to Caffeine

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Individualized caffeine cessation instructions
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Self-identified Problematic Caffeine Use focused on measuring Caffeine dependence, Caffeine withdrawal

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Behavioral Biology Research Center, Johns Hopkins Bayview

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Delayed intervention control

Arm Description

Outcomes

Primary Outcome Measures

self-reported caffeine use

Secondary Outcome Measures

biological measures of caffeine use
mood questionnaires

Full Information

First Posted
June 15, 2006
Last Updated
March 6, 2013
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00338195
Brief Title
Assessment and Treatment of Caffeine Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

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: 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.
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: 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. 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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self-identified Problematic Caffeine Use, DSM-IV Substance Dependence as Applied to Caffeine
Keywords
Caffeine dependence, Caffeine withdrawal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Delayed intervention control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Individualized caffeine cessation instructions
Intervention Description
Intervention is described in the protocol
Primary Outcome Measure Information:
Title
self-reported caffeine use
Time Frame
as described in protocol
Secondary Outcome Measure Information:
Title
biological measures of caffeine use
Time Frame
as described in protocol
Title
mood questionnaires
Time Frame
as described in protocol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland R Griffiths, Ph.D.
Organizational Affiliation
Professor, Johns Hopkins University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Behavioral Biology Research Center, Johns Hopkins Bayview
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

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Assessment and Treatment of Caffeine Dependence

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