Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338195
Status:
COMPLETED
Last Update Posted:
2013-03-07
First Post:
2006-06-15
Brief Title:
Assessment and Treatment of Caffeine Dependence
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
1 evaluate the applicability of DSM-IV dependence criteria for self-reported problematic caffeine use
2 evaluate characteristics eg 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 quitreduce caffeine use but have found it difficult to do so in the past
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 eg 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 quitreduce 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 eg 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 quitreduce 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 eg 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
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 eg 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 quitreduce 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DA001147 | NIH | None | httpsreporternihgovquickSearchR01DA001147 |