Assessment and Treatment of Caffeine Dependence

NCT ID: NCT00338195

Last Updated: 2013-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-31
• Study Completion Date: 2009-12-31

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.

Conditions

Self-identified Problematic Caffeine Use; DSM-IV Substance Dependence as Applied to Caffeine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Delayed intervention control

Group Type: NO_INTERVENTION

Individualized caffeine cessation instructions

Intervention Type: BEHAVIORAL

Intervention is described in the protocol

Interventions

Individualized caffeine cessation instructions

Intervention is described in the protocol

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Roland Griffiths

Professor, Department of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roland R Griffiths, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Professor, Johns Hopkins University School of Medicine

Locations

Behavioral Biology Research Center, Johns Hopkins Bayview

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

R01DA001147

Identifier Type: NIH

Identifier Source: secondary_id

View Link

BPR01-05-04-03

Identifier Type: -

Identifier Source: org_study_id