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Caffeine and Cocaine

This study has been completed.
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Frederick Gerard Moeller, Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00733993
First received: August 12, 2008
Last updated: February 1, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention Phase
Cocaine Dependence
Drug: Caffeine 150 MG
Drug: Placebo
Drug: Amphetamine
Drug: Caffeine 300 MG
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Basic Science
Official Title: Experiment 1: Adenosine Receptor A2A Antagonists and Cocaine Dependence

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • 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.

  • 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

  • Heart Rate [ Time Frame: Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours ]
    Sitting heart rate

  • 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)


  • 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 Outcome Measures:
  • 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.

  • 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.



Enrollment: 23
Study Start Date: April 2008
Study Completion Date: October 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Vivarin

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

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733993

Locations
United States, Texas
The University of Texas Health Science Center, Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Virginia Commonwealth University
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
  More Information

Additional Information:
Publications:
Responsible Party: Frederick Gerard Moeller, Professor - Division Chair, Addiction Psychiatry, Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00733993     History of Changes
Other Study ID Numbers: DA09262
P50DA009262 ( US NIH Grant/Contract Award Number )
DPMCDA
Study First Received: August 12, 2008
Results First Received: July 14, 2016
Last Updated: February 1, 2017

Keywords provided by Virginia Commonwealth University:
substance abuse
cocaine
caffeine
impulsivity

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Caffeine
Amphetamine
Cocaine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on April 25, 2017