Treatment for Caffeine Dependence

NCT ID: NCT01951872

Last Updated: 2017-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2017-03-31

Brief Summary

Recent research has shown that some individuals become addicted to or dependent on caffeine and are unable to quit or reduce caffeine consumption despite a persistent desire to do so. The aims of the current study are to characterize caffeine use among individuals with physical or psychological dependence on caffeine and evaluate a manual-based intervention to promote caffeine reduction and cessation.

Detailed Description

A large percentage of caffeine users in the general population (56%) report a persistent desire or unsuccessful efforts to stop or reduce caffeine consumption. The aim of Study 1 is to recruit and identify individuals who are interested in receiving treatment to reduce or quit caffeine consumption. Individuals will be recruited from Baltimore, MD and surrounding communities via flyers and newspaper and radio advertisements. Those who are eligible will be invited to come to the Behavioral Pharmacology Research Unit located on the Johns Hopkins Bayview Medical Center campus in Baltimore, MD. After consent is obtained at intake (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 that will assess caffeine use and dependence. Individuals who meet eligibility criteria will be offered the opportunity to receive assistance to reduce or quit 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 or 2) delayed treatment. The conditions will be identical with the exception of a 6 week delay for the delayed treatment group. Participants will receive a caffeine reduction and cessation treatment manual during a brief treatment session at week 1. Treatment progress will be assessed during a study session approximately 7 weeks post-treatment, during a telephone interview approximately 8 weeks post-treatment, and during a follow-up telephone call approximately 27 weeks after the treatment session. Progress will be assessed via questionnaires, food diaries, and salivary caffeine measures.

Conditions

Caffeine Use Disorder (DSM-5 Condition for Further Study)

Study Design

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

Study Groups

Immediate treatment

Immediate manual-based treatment for caffeine dependence: administered within approximately one week following intake.

Group Type: EXPERIMENTAL

Manual-based treatment for caffeine dependence

Intervention Type: BEHAVIORAL

Participants will meet with a counselor to discuss plans for caffeine reduction or cessation, and they will receive a manual-based treatment to help guide them through caffeine reduction or cessation.

Delayed treatment

Delayed manual-based treatment for caffeine dependence: administered within approximately six weeks following intake.

Group Type: EXPERIMENTAL

Manual-based treatment for caffeine dependence

Intervention Type: BEHAVIORAL

Participants will meet with a counselor to discuss plans for caffeine reduction or cessation, and they will receive a manual-based treatment to help guide them through caffeine reduction or cessation.

Interventions

Manual-based treatment for caffeine dependence

Participants will meet with a counselor to discuss plans for caffeine reduction or cessation, and they will receive a manual-based treatment to help guide them through caffeine reduction or cessation.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Medically healthy
• Self-reported problem with caffeine use
• Moderate to heavy caffeine use

Exclusion Criteria

• Pregnancy
• Current dependence on alcohol or illicit drugs

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roland R Griffiths, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

R01DA003890

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00051415

Identifier Type: -

Identifier Source: org_study_id