Treatment for Caffeine Dependence

Not Applicable

Completed

• Conditions: Caffeine Use Disorder (DSM-5 Condition for Further Study)
• Interventions: Behavioral: Manual-based treatment for caffeine dependence

• Registration Number: NCT01951872
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-20
• Study First Submitted QC: 2013-09-24
• Study First Posted: 2013-09-27
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-15
• Last Update Posted: 2017-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate treatment	Manual-based treatment for caffeine dependence	Immediate manual-based treatment for caffeine dependence: administered within approximately one week following intake.
Delayed treatment	Manual-based treatment for caffeine dependence	Delayed manual-based treatment for caffeine dependence: administered within approximately six weeks following intake.

Primary Outcome Measures

Name	Time	Method
Change in self-reported caffeine use	Measure will be assessed at weeks 1, 7, 8, and 27.

Secondary Outcome Measures

Name	Time	Method
Change in biological measure of caffeine use	Measure will be assessed at weeks 1 and 7.	Salivary caffeine

Trial Locations

Locations (1)

Behavioral Pharmacology Research Unit; 🇺🇸 Baltimore, Maryland, United States