Assessment and Treatment of Caffeine Dependence

Phase 1

Completed

• Conditions: Self-identified Problematic Caffeine Use; DSM-IV Substance Dependence as Applied to Caffeine
• Interventions: Behavioral: Individualized caffeine cessation instructions

• Registration Number: NCT00338195
• Lead Sponsor: Johns Hopkins University

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 (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.

Study Timeline

• Study Start: 2001-05
• Study First Submitted: 2006-06-15
• Study First Submitted QC: 2006-06-15
• Study First Posted: 2006-06-20
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-06
• Last Update Posted: 2013-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed intervention control	Individualized caffeine cessation instructions	-

Primary Outcome Measures

Name	Time	Method
self-reported caffeine use	as described in protocol

Secondary Outcome Measures

Name	Time	Method
biological measures of caffeine use	as described in protocol
mood questionnaires	as described in protocol

Trial Locations

Locations (1)

Behavioral Biology Research Center, Johns Hopkins Bayview; 🇺🇸 Baltimore, Maryland, United States