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Caffeine and Cocaine

Primary Purpose

Cocaine Dependence

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Caffeine 150 MG
Placebo
Amphetamine
Caffeine 300 MG
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cocaine Dependence focused on measuring substance abuse, cocaine, caffeine, impulsivity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The University of Texas Health Science Center, Houston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

1 Caffeine 150 mg

2 Placebo

3 Amphetamine

4 Caffeine 300 mg

Arm Description

Caffeine 150 mg

Placebo

Amphetamine

Caffeine 300 mg

Outcomes

Primary Outcome Measures

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.
Systolic and Diastolic Blood Pressure
Sitting Blood Pressure
Heart Rate
Sitting heart rate
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)
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 12, 2008
Last Updated
February 1, 2017
Sponsor
Virginia Commonwealth University
Collaborators
National Institute on Drug Abuse (NIDA), The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT00733993
Brief Title
Caffeine and Cocaine
Official Title
Experiment 1: Adenosine Receptor A2A Antagonists and Cocaine Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Institute on Drug Abuse (NIDA), The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
Keywords
substance abuse, cocaine, caffeine, impulsivity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Caffeine 150 mg
Arm Type
Experimental
Arm Description
Caffeine 150 mg
Arm Title
2 Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
3 Amphetamine
Arm Type
Experimental
Arm Description
Amphetamine
Arm Title
4 Caffeine 300 mg
Arm Type
Experimental
Arm Description
Caffeine 300 mg
Intervention Type
Drug
Intervention Name(s)
Caffeine 150 MG
Other Intervention Name(s)
Vivarin
Intervention Description
Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
Intervention Type
Drug
Intervention Name(s)
Amphetamine
Intervention Description
Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
Intervention Type
Drug
Intervention Name(s)
Caffeine 300 MG
Other Intervention Name(s)
Vivarin
Intervention Description
Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
Primary Outcome Measure Information:
Title
Visual Analog Scale Subjective Rating of Drug Effects
Description
Visual Analog Scale Rating. Scores range from 0 to 100 with higher scores meaning greater intensity of response being rated.
Time Frame
Immediately after dose
Title
Systolic and Diastolic Blood Pressure
Description
Sitting Blood Pressure
Time Frame
Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours
Title
Heart Rate
Description
Sitting heart rate
Time Frame
Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours
Title
Addiction Research Center Inventory Subjective Rating of Drug Effects
Description
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)
Time Frame
Immediately after dose
Title
Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects
Description
Assessments measured using a 4 item Drug Effects Questionnaire (DEQ) Ranges from 0 to 100 with higher numbers showing greater effect for each scale.
Time Frame
Immediately after dose
Secondary Outcome Measure Information:
Title
Probabalistic Feedback Selection Task
Description
Accuracy on a range from 0 to 1 of correctly performing a learning task, with 1 being the highest degree of accuracy.
Time Frame
75 minutes after dose
Title
Saliva Caffeine and Paraxanthine Levels
Description
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.
Time Frame
30 minutes prior to dose, 30/90/150 minutes post dose.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick G Moeller, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center, Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25414797
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.
Results Reference
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Caffeine and Cocaine

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