Caffeine and Cocaine

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Completed
CT.gov ID
NCT00733993
Collaborator
National Institute on Drug Abuse (NIDA) (NIH), The University of Texas Health Science Center, Houston (Other)
23
1
4
42
0.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Experiment 1: Adenosine Receptor A2A Antagonists and Cocaine Dependence
Study Start Date :
Apr 1, 2008
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Oct 1, 2011

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Visual Analog Scale Subjective Rating of Drug Effects [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 [Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours]

      Sitting Blood Pressure

    3. Heart Rate [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 [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 [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

    1. Probabalistic Feedback Selection Task [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Frederick Gerard Moeller, Professor - Division Chair, Addiction Psychiatry, Virginia Commonwealth University
    ClinicalTrials.gov Identifier:
    NCT00733993
    Other Study ID Numbers:
    • DA09262
    • P50DA009262
    • DPMCDA
    First Posted:
    Aug 13, 2008
    Last Update Posted:
    Mar 22, 2017
    Last Verified:
    Feb 1, 2017
    Keywords provided by Frederick Gerard Moeller, Professor - Division Chair, Addiction Psychiatry, Virginia Commonwealth University
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Cocaine Users Control Participants
    Arm/Group Description Cocaine users were allocated to different sequence orders for the 5 interventions Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion Control participants were allocated to different sequence orders for the 5 interventions Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
    Period Title: Overall Study
    STARTED 13 10
    COMPLETED 13 10
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Cocaine Users Control Participants Total
    Arm/Group 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 Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion Total of all reporting groups
    Overall Participants 13 10 23
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    13
    100%
    10
    100%
    23
    100%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    3
    23.1%
    5
    50%
    8
    34.8%
    Male
    10
    76.9%
    5
    50%
    15
    65.2%
    Region of Enrollment (participants) [Number]
    United States
    13
    100%
    10
    100%
    23
    100%

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Placebo Caffeine 150 Mg Caffeine 300 mg Amphetamine 20 mg
    Arm/Group Description Placebo 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 150 MG of Caffeine Caffeine 300 mg Amphetamine 20 mg
    Measure Participants 23 23 23 23
    Elation: Control (N=10)
    8.65
    (5.33)
    9.85
    (5.32)
    13.65
    (6.1)
    10.43
    (4.48)
    Elation: Cocaine (N=13)
    25.99
    (6.01)
    32.54
    (7.62)
    21.65
    (5.68)
    25.71
    (6.42)
    Anxious: Control (N=10)
    10.15
    (5.31)
    10.45
    (5.69)
    8.50
    (4.91)
    11.68
    (4.62)
    Anxious: Cocaine (N=13)
    19.64
    (6.17)
    21.35
    (6.01)
    25.27
    (7.12)
    21.71
    (5.43)
    Vigor: Control (N=10)
    8.25
    (2.06)
    8.50
    (1.92)
    9.78
    (1.98)
    8.28
    (2.01)
    Vigor: Cocaine (N=13)
    10.42
    (1.54)
    10.85
    (1.59)
    9.27
    (1.60)
    10.31
    (1.33)
    Tension: Control (N=10)
    1.05
    (0.38)
    1.60
    (0.53)
    1.62
    (0.60)
    1.53
    (0.48)
    Tension: Cocaine (N=13)
    1.63
    (0.62)
    0.96
    (0.57)
    2.38
    (0.94)
    1.88
    (0.61)
    Fatigue: Control (N=10)
    3.85
    (1.37)
    3.00
    (1.48)
    3.44
    (1.64)
    3.60
    (1.07)
    Fatigue: Cocaine (N=13)
    0.68
    (0.32)
    0.54
    (0.25)
    1.69
    (0.71)
    1.17
    (0.36)
    Depression: Control (N=10)
    0.10
    (0.10)
    0.10
    (0.10)
    0.41
    (0.30)
    0.10
    (0.06)
    Depression: Cocaine (N=13)
    1.05
    (0.54)
    0.62
    (0.47)
    1.96
    (1.12)
    1.10
    (0.51)
    2. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Placebo Caffeine 150 Mg Caffeine 300 mg Amphetamine 20mg
    Arm/Group Description Placebo 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 150 MG of Caffeine Caffeine 300mg Amphetamine 20mg
    Measure Participants 23 23 23 23
    SBP Control (N=10)
    115.64
    (3.41)
    115.9
    (4.07)
    117.36
    (4.2)
    119.27
    (2.13)
    SBP Cocaine (N=13)
    120.18
    (1.40)
    122.10
    (1.81)
    123.84
    (2.18)
    120.30
    (1.58)
    DBP Control (N=10)
    74.82
    (2.78)
    75.33
    (2.72)
    77.94
    (1.42)
    77.83
    (1.45)
    DBP Cocaine (N=13)
    79.66
    (3.01)
    79.98
    (1.79)
    82.81
    (1.74)
    78.16
    (1.56)
    3. Primary Outcome
    Title Heart Rate
    Description Sitting heart rate
    Time Frame Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Placebo Caffeine 150 Mg Caffeine 300 mg Amphetamine 20mg
    Arm/Group Description Placebo 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 150 MG of Caffeine Caffeine 300mg Amphetamine 20mg
    Measure Participants 23 23 23 23
    Control (N=10)
    66.10
    (1.88)
    62.47
    (2.09)
    61.33
    (1.67)
    65.55
    (1.23)
    Cocaine (N=13)
    63.08
    (2.11)
    62.60
    (3.00)
    61.57
    (1.40)
    63.51
    (2.99)
    4. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Placebo Caffeine 150 Mg Caffeine 300 mg Amphetamine 20 mg
    Arm/Group Description Placebo 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 150 MG of Caffeine Caffeine 300 mg Amphetamine 20 mg
    Measure Participants 23 23 23 23
    PCAG: Control (N=10)
    3.87
    (0.82)
    3.62
    (0.83)
    3.52
    (0.79)
    3.64
    (0.71)
    PCAG: Cocaine (N=13)
    1.95
    (0.58)
    1.83
    (0.68)
    2.95
    (0.82)
    2.43
    (0.67)
    A: Control (N=10)
    3.20
    (0.51)
    3.60
    (0.68)
    3.80
    (0.59)
    3.22
    (0.38)
    A: Cocaine (N=13)
    3.30
    (0.51)
    3.39
    (0.54)
    3.19
    (0.44)
    3.69
    (0.45)
    BG: Control (N=10)
    6.00
    (0.39)
    6.35
    (0.56)
    6.05
    (0.57)
    5.83
    (0.36)
    BG: Cocaine (N=13)
    5.69
    (0.34)
    5.77
    (0.37)
    5.07
    (0.61)
    5.57
    (0.51)
    MGB: Control (N=10)
    4.09
    (1.26)
    4.34
    (1.31)
    5.14
    (1.37)
    4.04
    (1.28)
    MGB: Cocaine (N=13)
    5.29
    (1.13)
    5.62
    (1.23)
    4.31
    (0.96)
    5.18
    (1.00)
    LSD: Control (N=10)
    1.78
    (0.44)
    2.43
    (0.56)
    1.23
    (0.41)
    1.70
    (0.41)
    LSD: Cocaine (N=13)
    0.89
    (0.47)
    0.48
    (0.49)
    1.05
    (0.49)
    0.98
    (0.45)
    5. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Placebo Caffeine 150 Mg Caffeine 300 mg Amphetamine 20 mg
    Arm/Group Description Placebo 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 150 MG of Caffeine Caffeine 300 mg Amphetamine 20 mg
    Measure Participants 23 23 23 23
    Feel effects:Control (N=10)
    16.75
    (7.58)
    20.25
    (6.31)
    9.45
    (4.97)
    11.37
    (4.93)
    Feel effects:Cocaine (N=13)
    17.30
    (5.80)
    20.73
    (5.95)
    17.62
    (5.91)
    18.68
    (6.08)
    Like effects:Control (N=10)
    39.92
    (6.82)
    35.62
    (6.89)
    52.17
    (6.95)
    42.25
    (5.74)
    Like effects:Cocaine (N=13)
    37.18
    (9.74)
    39.94
    (10.55)
    43.75
    (7.21)
    32.04
    (8.63)
    High:Control (N=10)
    10.77
    (5.23)
    12.17
    (5.59)
    7.17
    (4.16)
    7.17
    (3.95)
    High:Cocaine (N=13)
    14.35
    (5.45)
    16.14
    (5.67)
    15.87
    (5.78)
    14.64
    (5.44)
    Like more:Control (N=10)
    25.77
    (7.20)
    25.62
    (6.54)
    32.92
    (7.01)
    25.65
    (6.08)
    Like more:Cocaine (N=13)
    25.96
    (9.18)
    25.68
    (8.99)
    28.71
    (8.48)
    26.16
    (8.69)
    6. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Placebo Caffeine 150 Mg Caffeine 300 mg Amphetamine 20mg
    Arm/Group Description Placebo 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 150 MG of Caffeine Caffeine 300mg Amphetamine 20mg
    Measure Participants 23 23 23 23
    Control (N=10)
    0.56
    (0.02)
    0.55
    (0.03)
    0.56
    (0.02)
    0.61
    (0.02)
    Cocaine (N=13)
    0.54
    (0.01)
    0.56
    (0.02)
    0.58
    (0.02)
    0.56
    (0.02)
    7. Secondary Outcome
    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.

    Outcome Measure Data

    Analysis Population Description
    Assessment was not performed for amphetamine intervention
    Arm/Group Title Placebo Caffeine 150 Mg Caffeine 300 mg Amphetamine 20mg
    Arm/Group Description Placebo 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 150 MG of Caffeine Caffeine 300mg Amphetamine 20mg
    Measure Participants 21 21 21 0
    Caffeine -30 min Control (N=10)
    1000
    (490)
    510
    (470)
    335
    (110)
    Caffeine 30 min Control (N=10)
    983
    (440)
    2715
    (1110)
    2895
    (998)
    Caffeine 90 min Control (N=10)
    984
    (445)
    2225
    (995)
    3510
    (1001)
    Caffeine 150 min Control (N=10)
    984
    (601)
    1910
    (898)
    3270
    (901)
    Caffeine -30 min Cocaine (N=11)
    990
    (920)
    998
    (820)
    1201
    (997)
    Caffeine 30 min Cocaine (N=11)
    780
    (510)
    2125
    (1001)
    3510
    (1220)
    Caffeine 90 min Cocaine (N=11)
    625
    (410)
    2077
    (874)
    3720
    (911)
    Caffeine 150 min Cocaine (N=11)
    510
    (322)
    1909
    (605)
    3205
    (697)
    Parathanxine -30 min Control (N=10)
    440
    (155)
    274
    (140)
    198
    (92)
    Parathanxine 30 min Control (N=10)
    410
    (240)
    301
    (238)
    202
    (101)
    Parathanxine 90 min Control (N=10)
    411
    (219)
    402
    (155)
    397
    (110)
    Parathanxine 150 min Control (N=10)
    410
    (143)
    411
    (145)
    462
    (215)
    Parathanxine -30 min Cocaine (N=11)
    334
    (205)
    401
    (197)
    408
    (240)
    Parathanxine 30 min Cocaine (N=11)
    320
    (275)
    465
    (185)
    656
    (280)
    Parathanxine 90 min Cocaine (N=11)
    321
    (248)
    601
    (233)
    985
    (245)
    Parathanxine 150 min Cocaine (N=11)
    296
    (252)
    605
    (247)
    1014
    (255)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title 1 Caffeine 2 Placebo 3 Amphetamine
    Arm/Group Description Caffeine Caffeine: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion Placebo 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 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
    All Cause Mortality
    1 Caffeine 2 Placebo 3 Amphetamine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    1 Caffeine 2 Placebo 3 Amphetamine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/23 (0%) 0/23 (0%) 0/23 (0%)
    Other (Not Including Serious) Adverse Events
    1 Caffeine 2 Placebo 3 Amphetamine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/23 (0%) 0/23 (0%) 0/23 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title F. Gerard Moeller
    Organization Virginia Commonwealth University
    Phone 804-828-4134
    Email fgmoeller@vcu.edu
    Responsible Party:
    Frederick Gerard Moeller, Professor - Division Chair, Addiction Psychiatry, Virginia Commonwealth University
    ClinicalTrials.gov Identifier:
    NCT00733993
    Other Study ID Numbers:
    • DA09262
    • P50DA009262
    • DPMCDA
    First Posted:
    Aug 13, 2008
    Last Update Posted:
    Mar 22, 2017
    Last Verified:
    Feb 1, 2017