Assessment and Treatment of Caffeine Dependence
Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Self-identified Problematic Caffeine Use; DSM-IV Substance Dependence as Applied to Caffeine
Intervention: Individualized caffeine cessation instructions (Behavioral)
Phase: Phase 1
Status: Completed
Sponsored by: Johns Hopkins University Official(s) and/or principal investigator(s): Roland R Griffiths, Ph.D., Principal Investigator, Affiliation: Professor, Johns Hopkins University School of Medicine
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: self-reported caffeine use
Secondary outcome: biological measures of caffeine usemood questionnaires
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Behavioral Biology Research Center, Johns Hopkins Bayview, Baltimore, Maryland 21224, United States
Additional Information
Information about caffeine dependence
Starting date: May 2001
Last updated: March 6, 2013
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