Clinical trial NCT01951872: Treatment for Caffeine Dependence
Official title: Treatment for Caffeine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caffeine Use Disorder (DSM-5 Condition for Further Study)
Keywords: caffeine dependence
caffeine withdrawal
caffeine use disorder
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-09-27
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in self-reported caffeine use
timeFrame: Measure will be assessed at weeks 1, 7, 8, and 27.
Secondary outcomes:
measure: Change in biological measure of caffeine use
timeFrame: Measure will be assessed at weeks 1 and 7.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Behavioral Pharmacology Research Unit
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Roland R Griffiths, PhD
role: PRINCIPAL_INVESTIGATOR
References: