Caffeine and Cocaine

Experiment 1: Adenosine Receptor A2A Antagonists and Cocaine Dependence

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.

Study Overview

• Status: Completed
• Conditions: Cocaine Dependence
• Intervention / Treatment: Drug: Caffeine 150 MG; Drug: Placebo; Drug: Amphetamine; Drug: Caffeine 300 MG

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center, Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1 Caffeine 150 mg; Caffeine 150 mg	Drug: Caffeine 150 MG; 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 Comparator: 2 Placebo; Placebo	Drug: Placebo; Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
Experimental: 3 Amphetamine; Amphetamine	Drug: Amphetamine; Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
Experimental: 4 Caffeine 300 mg; Caffeine 300 mg	Drug: Caffeine 300 MG; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale Subjective Rating of Drug Effects	Visual Analog Scale Rating. Scores range from 0 to 100 with higher scores meaning greater intensity of response being rated.	Immediately after dose
Systolic and Diastolic Blood Pressure	Sitting Blood Pressure	Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours
Heart Rate	Sitting heart rate	Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours
Addiction Research Center Inventory Subjective Rating of Drug Effects	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)	Immediately after dose
Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects	Assessments measured using a 4 item Drug Effects Questionnaire (DEQ) Ranges from 0 to 100 with higher numbers showing greater effect for each scale.	Immediately after dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probabalistic Feedback Selection Task	Accuracy on a range from 0 to 1 of correctly performing a learning task, with 1 being the highest degree of accuracy.	75 minutes after dose
Saliva Caffeine and Paraxanthine Levels	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.	30 minutes prior to dose, 30/90/150 minutes post dose.

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Institute on Drug Abuse (NIDA); The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Frederick G Moeller, MD, The University of Texas Health Science Center, Houston

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: August 12, 2008
• First Submitted That Met QC Criteria: August 12, 2008
• First Posted (Estimate): August 13, 2008

Study Record Updates

• Last Update Posted (Actual): March 22, 2017
• Last Update Submitted That Met QC Criteria: February 1, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: substance abuse; caffeine; cocaine; impulsivity
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Cocaine-Related Disorders; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Caffeine; Amphetamine
• Other Study ID Numbers: DA09262; DPMCDA (Other Identifier: NIDA); P50DA009262 (U.S. NIH Grant/Contract)