Clinical trial NCT00733993: Caffeine and Cocaine
Official title: Experiment 1: Adenosine Receptor A2A Antagonists and Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cocaine Dependence
Keywords: substance abuse
cocaine
caffeine
impulsivity
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: The University of Texas Health Science Center, Houston
First posted: 2008-08-13
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Subjects who currently meet DSM-IV criteria for cocaine dependence and healthy controls
* At least one cocaine positive urine during screening.
* Current regular consumption of caffeine.
* Female subjects: a negative pregnancy test.

Exclusion Criteria:

* Current or past DSM-IV Axis I disorder other than substance abuse/ dependence
* Any significant non-psychiatric medical illness requiring ongoing medical treatment or which would preclude treatment with d-amphetamine or caffeine
* Substance dependence other than cocaine within the last 3 months.
* Positive breath alcohol.
* Positive urine drug screen for drugs other than cocaine or THC at the time of behavioral testing
* For female subjects: known pregnancy or a positive pregnancy test or current breast feeding.
* Diagnosis of Adult Attention Deficit Disorder as determined by: a) meeting DSM-IV criteria for childhood ADHD, b) currently has impairing ADHD symptoms, c) ADHD symptoms can not have remitted at any period since childhood.
* HIV positive.
* I.Q. below 70.

Primary outcomes:
measure: Visual Analog Scale Subjective Rating of Drug Effects
timeFrame: Immediately after dose
measure: Systolic and Diastolic Blood Pressure
timeFrame: Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours
measure: Heart Rate
timeFrame: Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours
measure: Addiction Research Center Inventory Subjective Rating of Drug Effects
timeFrame: Immediately after dose
measure: Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects
timeFrame: Immediately after dose
Secondary outcomes:
measure: Probabalistic Feedback Selection Task
timeFrame: 75 minutes after dose
measure: Saliva Caffeine and Paraxanthine Levels
timeFrame: 30 minutes prior to dose, 30/90/150 minutes post dose.
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center, Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Frederick G Moeller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lane SD, Green CE, Schmitz JM, Rathnayaka N, Fang WB, Ferre S, Moeller FG. Comparison of Caffeine and d-amphetamine in Cocaine-Dependent Subjects: Differential Outcomes on Subjective and Cardiovascular Effects, Reward Learning, and Salivary Paraxanthine. J Addict Res Ther. 2014;5(2):176. doi: 10.4172/2155-6105.1000176.