Treatment for Caffeine Dependence

Study Overview
=================
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.

Official Title
-----------------
Treatment for Caffeine Dependence

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

Intervention / Treatment
-----------------
* Behavioral: Manual-based treatment for caffeine dependence


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate treatment<br>Immediate manual-based treatment for caffeine dependence: administered within approximately one week following intake. | Behavioral: Manual-based treatment for caffeine dependence<br>* 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.<br>|
| Experimental: Delayed treatment<br>Delayed manual-based treatment for caffeine dependence: administered within approximately six weeks following intake. | Behavioral: Manual-based treatment for caffeine dependence<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-reported caffeine use |  | Measure will be assessed at weeks 1, 7, 8, and 27. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in biological measure of caffeine use | Salivary caffeine | Measure will be assessed at weeks 1 and 7. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
caffeine dependence, caffeine withdrawal, caffeine use disorder