Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00338195 |
| Other study ID # |
BPR01-05-04-03 |
| Secondary ID |
R01DA001147 |
| Status |
Completed |
| Phase |
Phase 1
|
| First received |
June 15, 2006 |
| Last updated |
March 6, 2013 |
| Start date |
May 2001 |
| Est. completion date |
December 2009 |
Study information
| Verified date |
March 2013 |
| Source |
Johns Hopkins University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Interventional
|
Clinical Trial 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.
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.
