Caffeine & Cocaine

Status Completed

Clinical Trial Summary

This study is being done to find out if medicines that affect a neurotransmitter (chemical messenger) in the brain called adenosine improve behavioral problems that are related to drug abuse. Another purpose of the study is to find out how genes related to adenosine change how people respond to these medicines. More information about how these medicines change behaviors may be helpful to come up with new treatments for drug abuse.

Clinical Trial Description

Specific Aims:

Aim 1. To characterize the behavioral and subjective effects of acute caffeine administration in cocaine-dependent subjects, using laboratory measures of impulse control, drug discrimination (with d-amphetamine as the training dose), and subjective effects.

Hypotheses related to Aim 1:

1. Subjects will show decreases in impulsivity (delay to reward and response inhibition) after acute oral doses of caffeine compared to placebo.

2. Subjects will show some stimulant-like subjective effects following acute oral doses of caffeine, but not the euphoric effects that would predict abuse potential.

3. Following training doses of placebo and 20 mg d-amphetamine, oral doses of caffeine will be discriminated as being different than 20 mg d-amphetamine and different from placebo.

Aim 2. To determine the effect of a 2-week trial of oral caffeine on laboratory measures of impulsivity and cue reactivity in cocaine dependent subjects.

Hypothesis related to Aim 2:

1. Daily caffeine (600 - 900 mg) treatment will decrease impulsivity (delay to reward and response inhibition) compared to placebo.

2. Daily caffeine (600 - 900 mg) treatment will decrease cocaine related cue reactivity compared to placebo.

Secondary Aims:

Secondary Aim 1. To examine the effect of 2-weeks of treatment with caffeine on cocaine use in cocaine dependent subjects.

Secondary hypothesis 1: Cocaine dependent subjects treated with caffeine will show a significant reduction in cocaine positive urine drug screens compared with cocaine dependent subjects treated with placebo.

Secondary Aim 2. To examine the relationship between gene polymorphisms for the A2A receptor gene and behavioral effects of caffeine Secondary hypothesis 2: Genetic variation in the adenosine A2A receptor gene (ADORA2A) will be associated with the behavioral effects of caffeine. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00733993
Study type	Interventional
Source	Virginia Commonwealth University
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	April 2008
Completion date	October 2011

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Caffeine and Cocaine

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms