Skip to main content
OpenTrials
Completed

NCT Number: NCT00733993

Caffeine and Cocaine

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cocaine Dependence Behavior Chemically-Induced Disorders Cocaine-Related Disorders Impulsive Behavior Mental Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The University of Texas Health Science Center, Houston

Houston, Texas, 77030, United States

About this study

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:

  • Subjects will show decreases in impulsivity (delay to reward and response inhibition) after acute oral doses of caffeine compared to placebo.
  • Subjects will show some stimulant-like subjective effects following acute oral doses of caffeine, but not the euphoric effects that would predict abuse potential.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Caffeine 150 MG

Drug

Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion

Other names: Vivarin

Placebo

Drug

Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion

Amphetamine

Drug

Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion

Caffeine 300 MG

Drug

Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion

Other names: Vivarin

Primary outcomes

  1. Visual Analog Scale Subjective Rating of Drug Effects

    Time frame: Immediately after dose

    Visual Analog Scale Rating. Scores range from 0 to 100 with higher scores meaning greater intensity of response being rated.

  2. Systolic and Diastolic Blood Pressure

    Time frame: Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours

    Sitting Blood Pressure

  3. Heart Rate

    Time frame: Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours

    Sitting heart rate

  4. Addiction Research Center Inventory Subjective Rating of Drug Effects

    Time frame: Immediately after dose

    Addiction Research Center Inventory (ARCI 49). T/F scales with 49 items.

    Includes the following subscales:

    Morphine-Benzedrine Group (MBG), includes euphoria (0 to +16, higher numbers = more euphoria) Phenobarbital-Chorpromazine-Alcohol Group (PCAG), includes sedation (-3 to +11, higher scores = more sedation) Lysergic Acid Diethylmide Group (LSD) , includes dysphoria and agitation (-4 to +10, higher scores = more dysphoria) Amphetamine Group (A), includes stimulation ( 0 to +11, higher scores = more stimulation) Benzedrine Group (BG), includes energy and "intellectual efficiacy" (+4 to +9, higher scores = more energy)

  5. Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects

    Time frame: Immediately after dose

    Assessments measured using a 4 item Drug Effects Questionnaire (DEQ) Ranges from 0 to 100 with higher numbers showing greater effect for each scale.

Secondary outcomes

  1. Probabalistic Feedback Selection Task

    Time frame: 75 minutes after dose

    Accuracy on a range from 0 to 1 of correctly performing a learning task, with 1 being the highest degree of accuracy.

  2. Saliva Caffeine and Paraxanthine Levels

    Time frame: 30 minutes prior to dose, 30/90/150 minutes post dose.

    Due to insufficient oral volume or breakage during sample transfer, data were lost or incomplete for two cocaine-dependent subjects.

    Analyses for the saliva data represent 11 cocaine-dependent subjects and 10 controls.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • The University of Texas Health Science Center, Houston

Registry information

Official study title

Experiment 1: Adenosine Receptor A2A Antagonists and Cocaine Dependence

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 13, 2008
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.