Assessment and Treatment of Caffeine Dependence
Condition: Self-identified Problematic Caffeine Use; DSM-IV Substance Dependence as Applied to Caffeine
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

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.
    

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.
    

Intervention name(s): Individualized caffeine cessation instructions
Intervention type(s): Behavioral
Intervention description(s): Intervention is described in the protocol
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Caffeine dependence; Caffeine withdrawal