Cocaine Dependence
Conditions
Keywords
substance abuse, cocaine, caffeine, impulsivity
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: 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.
Interventions
DRUGAmphetamine
Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
DRUGCaffeine 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
DRUGPlacebo
Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
DRUGCaffeine 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
Sponsors
National Institute on Drug Abuse (NIDA)
The University of Texas Health Science Center, Houston
Virginia Commonwealth University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic and Diastolic Blood Pressure | Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours | Sitting Blood Pressure |
| 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) |
| 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. |
| 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. |
| Heart Rate | Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours | Sitting heart rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cocaine Users Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion | 13 |
| Control Participants Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion | 10 |
| Total | 23 |
Baseline characteristics
| Characteristic | Cocaine Users | Control Participants | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 10 Participants | 23 Participants |
| Region of Enrollment United States | 13 participants | 10 participants | 23 participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 8 Participants |
| Sex: Female, Male Male | 10 Participants | 5 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 23 | 0 / 23 | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 | 0 / 23 |
Outcome results
Primary
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)
Time frame: Immediately after dose
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Addiction Research Center Inventory Subjective Rating of Drug Effects | BG: Cocaine (N=13) | 5.69 units on a scale | Standard Error 0.34 |
| Placebo | Addiction Research Center Inventory Subjective Rating of Drug Effects | BG: Control (N=10) | 6.00 units on a scale | Standard Error 0.39 |
| Placebo | Addiction Research Center Inventory Subjective Rating of Drug Effects | A: Control (N=10) | 3.20 units on a scale | Standard Error 0.51 |
| Placebo | Addiction Research Center Inventory Subjective Rating of Drug Effects | PCAG: Control (N=10) | 3.87 units on a scale | Standard Error 0.82 |
| Placebo | Addiction Research Center Inventory Subjective Rating of Drug Effects | A: Cocaine (N=13) | 3.30 units on a scale | Standard Error 0.51 |
| Placebo | Addiction Research Center Inventory Subjective Rating of Drug Effects | LSD: Control (N=10) | 1.78 units on a scale | Standard Error 0.44 |
| Placebo | Addiction Research Center Inventory Subjective Rating of Drug Effects | MGB: Cocaine (N=13) | 5.29 units on a scale | Standard Error 1.13 |
| Placebo | Addiction Research Center Inventory Subjective Rating of Drug Effects | MGB: Control (N=10) | 4.09 units on a scale | Standard Error 1.26 |
| Placebo | Addiction Research Center Inventory Subjective Rating of Drug Effects | PCAG: Cocaine (N=13) | 1.95 units on a scale | Standard Error 0.58 |
| Placebo | Addiction Research Center Inventory Subjective Rating of Drug Effects | LSD: Cocaine (N=13) | 0.89 units on a scale | Standard Error 0.47 |
| Caffeine 150 Mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | BG: Control (N=10) | 6.35 units on a scale | Standard Error 0.56 |
| Caffeine 150 Mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | MGB: Cocaine (N=13) | 5.62 units on a scale | Standard Error 1.23 |
| Caffeine 150 Mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | PCAG: Control (N=10) | 3.62 units on a scale | Standard Error 0.83 |
| Caffeine 150 Mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | PCAG: Cocaine (N=13) | 1.83 units on a scale | Standard Error 0.68 |
| Caffeine 150 Mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | A: Control (N=10) | 3.60 units on a scale | Standard Error 0.68 |
| Caffeine 150 Mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | A: Cocaine (N=13) | 3.39 units on a scale | Standard Error 0.54 |
| Caffeine 150 Mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | BG: Cocaine (N=13) | 5.77 units on a scale | Standard Error 0.37 |
| Caffeine 150 Mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | MGB: Control (N=10) | 4.34 units on a scale | Standard Error 1.31 |
| Caffeine 150 Mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | LSD: Control (N=10) | 2.43 units on a scale | Standard Error 0.56 |
| Caffeine 150 Mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | LSD: Cocaine (N=13) | 0.48 units on a scale | Standard Error 0.49 |
| Caffeine 300 mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | PCAG: Cocaine (N=13) | 2.95 units on a scale | Standard Error 0.82 |
| Caffeine 300 mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | PCAG: Control (N=10) | 3.52 units on a scale | Standard Error 0.79 |
| Caffeine 300 mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | MGB: Cocaine (N=13) | 4.31 units on a scale | Standard Error 0.96 |
| Caffeine 300 mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | BG: Control (N=10) | 6.05 units on a scale | Standard Error 0.57 |
| Caffeine 300 mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | LSD: Cocaine (N=13) | 1.05 units on a scale | Standard Error 0.49 |
| Caffeine 300 mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | BG: Cocaine (N=13) | 5.07 units on a scale | Standard Error 0.61 |
| Caffeine 300 mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | A: Control (N=10) | 3.80 units on a scale | Standard Error 0.59 |
| Caffeine 300 mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | LSD: Control (N=10) | 1.23 units on a scale | Standard Error 0.41 |
| Caffeine 300 mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | A: Cocaine (N=13) | 3.19 units on a scale | Standard Error 0.44 |
| Caffeine 300 mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | MGB: Control (N=10) | 5.14 units on a scale | Standard Error 1.37 |
| Amphetamine 20 mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | A: Cocaine (N=13) | 3.69 units on a scale | Standard Error 0.45 |
| Amphetamine 20 mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | BG: Control (N=10) | 5.83 units on a scale | Standard Error 0.36 |
| Amphetamine 20 mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | LSD: Control (N=10) | 1.70 units on a scale | Standard Error 0.41 |
| Amphetamine 20 mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | BG: Cocaine (N=13) | 5.57 units on a scale | Standard Error 0.51 |
| Amphetamine 20 mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | PCAG: Control (N=10) | 3.64 units on a scale | Standard Error 0.71 |
| Amphetamine 20 mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | LSD: Cocaine (N=13) | 0.98 units on a scale | Standard Error 0.45 |
| Amphetamine 20 mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | MGB: Control (N=10) | 4.04 units on a scale | Standard Error 1.28 |
| Amphetamine 20 mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | MGB: Cocaine (N=13) | 5.18 units on a scale | Standard Error 1 |
| Amphetamine 20 mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | A: Control (N=10) | 3.22 units on a scale | Standard Error 0.38 |
| Amphetamine 20 mg | Addiction Research Center Inventory Subjective Rating of Drug Effects | PCAG: Cocaine (N=13) | 2.43 units on a scale | Standard Error 0.67 |
Primary
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.
Time frame: Immediately after dose
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | High:Control (N=10) | 10.77 units on a scale | Standard Error 5.23 |
| Placebo | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | Feel effects:Control (N=10) | 16.75 units on a scale | Standard Error 7.58 |
| Placebo | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | Like more:Control (N=10) | 25.77 units on a scale | Standard Error 7.2 |
| Placebo | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | Like effects:Control (N=10) | 39.92 units on a scale | Standard Error 6.82 |
| Placebo | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | Like more:Cocaine (N=13) | 25.96 units on a scale | Standard Error 9.18 |
| Placebo | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | High:Cocaine (N=13) | 14.35 units on a scale | Standard Error 5.45 |
| Placebo | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | Like effects:Cocaine (N=13) | 37.18 units on a scale | Standard Error 9.74 |
| Placebo | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | Feel effects:Cocaine (N=13) | 17.30 units on a scale | Standard Error 5.8 |
| Caffeine 150 Mg | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | Like effects:Control (N=10) | 35.62 units on a scale | Standard Error 6.89 |
| Caffeine 150 Mg | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | Like more:Cocaine (N=13) | 25.68 units on a scale | Standard Error 8.99 |
| Caffeine 150 Mg | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | Feel effects:Cocaine (N=13) | 20.73 units on a scale | Standard Error 5.95 |
| Caffeine 150 Mg | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | Like more:Control (N=10) | 25.62 units on a scale | Standard Error 6.54 |
| Caffeine 150 Mg | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | High:Cocaine (N=13) | 16.14 units on a scale | Standard Error 5.67 |
| Caffeine 150 Mg | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | Like effects:Cocaine (N=13) | 39.94 units on a scale | Standard Error 10.55 |
| Caffeine 150 Mg | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | Feel effects:Control (N=10) | 20.25 units on a scale | Standard Error 6.31 |
| Caffeine 150 Mg | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | High:Control (N=10) | 12.17 units on a scale | Standard Error 5.59 |
| Caffeine 300 mg | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | High:Control (N=10) | 7.17 units on a scale | Standard Error 4.16 |
| Caffeine 300 mg | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | Like effects:Cocaine (N=13) | 43.75 units on a scale | Standard Error 7.21 |
| Caffeine 300 mg | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | Feel effects:Control (N=10) | 9.45 units on a scale | Standard Error 4.97 |
| Caffeine 300 mg | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | Like more:Control (N=10) | 32.92 units on a scale | Standard Error 7.01 |
| Caffeine 300 mg | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | High:Cocaine (N=13) | 15.87 units on a scale | Standard Error 5.78 |
| Caffeine 300 mg | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | Like effects:Control (N=10) | 52.17 units on a scale | Standard Error 6.95 |
| Caffeine 300 mg | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | Feel effects:Cocaine (N=13) | 17.62 units on a scale | Standard Error 5.91 |
| Caffeine 300 mg | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | Like more:Cocaine (N=13) | 28.71 units on a scale | Standard Error 8.48 |
| Amphetamine 20 mg | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | Like more:Cocaine (N=13) | 26.16 units on a scale | Standard Error 8.69 |
| Amphetamine 20 mg | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | Feel effects:Control (N=10) | 11.37 units on a scale | Standard Error 4.93 |
| Amphetamine 20 mg | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | Feel effects:Cocaine (N=13) | 18.68 units on a scale | Standard Error 6.08 |
| Amphetamine 20 mg | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | Like effects:Control (N=10) | 42.25 units on a scale | Standard Error 5.74 |
| Amphetamine 20 mg | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | Like effects:Cocaine (N=13) | 32.04 units on a scale | Standard Error 8.63 |
| Amphetamine 20 mg | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | High:Control (N=10) | 7.17 units on a scale | Standard Error 3.95 |
| Amphetamine 20 mg | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | Like more:Control (N=10) | 25.65 units on a scale | Standard Error 6.08 |
| Amphetamine 20 mg | Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects | High:Cocaine (N=13) | 14.64 units on a scale | Standard Error 5.44 |
Primary
Heart Rate
Sitting heart rate
Time frame: Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Heart Rate | Control (N=10) | 66.10 Beats per minute | Standard Error 1.88 |
| Placebo | Heart Rate | Cocaine (N=13) | 63.08 Beats per minute | Standard Error 2.11 |
| Caffeine 150 Mg | Heart Rate | Cocaine (N=13) | 62.60 Beats per minute | Standard Error 3 |
| Caffeine 150 Mg | Heart Rate | Control (N=10) | 62.47 Beats per minute | Standard Error 2.09 |
| Caffeine 300 mg | Heart Rate | Control (N=10) | 61.33 Beats per minute | Standard Error 1.67 |
| Caffeine 300 mg | Heart Rate | Cocaine (N=13) | 61.57 Beats per minute | Standard Error 1.4 |
| Amphetamine 20 mg | Heart Rate | Control (N=10) | 65.55 Beats per minute | Standard Error 1.23 |
| Amphetamine 20 mg | Heart Rate | Cocaine (N=13) | 63.51 Beats per minute | Standard Error 2.99 |
Primary
Systolic and Diastolic Blood Pressure
Sitting Blood Pressure
Time frame: Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Systolic and Diastolic Blood Pressure | SBP Control (N=10) | 115.64 mmHg | Standard Error 3.41 |
| Placebo | Systolic and Diastolic Blood Pressure | DBP Cocaine (N=13) | 79.66 mmHg | Standard Error 3.01 |
| Placebo | Systolic and Diastolic Blood Pressure | SBP Cocaine (N=13) | 120.18 mmHg | Standard Error 1.4 |
| Placebo | Systolic and Diastolic Blood Pressure | DBP Control (N=10) | 74.82 mmHg | Standard Error 2.78 |
| Caffeine 150 Mg | Systolic and Diastolic Blood Pressure | DBP Control (N=10) | 75.33 mmHg | Standard Error 2.72 |
| Caffeine 150 Mg | Systolic and Diastolic Blood Pressure | DBP Cocaine (N=13) | 79.98 mmHg | Standard Error 1.79 |
| Caffeine 150 Mg | Systolic and Diastolic Blood Pressure | SBP Control (N=10) | 115.9 mmHg | Standard Error 4.07 |
| Caffeine 150 Mg | Systolic and Diastolic Blood Pressure | SBP Cocaine (N=13) | 122.10 mmHg | Standard Error 1.81 |
| Caffeine 300 mg | Systolic and Diastolic Blood Pressure | SBP Cocaine (N=13) | 123.84 mmHg | Standard Error 2.18 |
| Caffeine 300 mg | Systolic and Diastolic Blood Pressure | SBP Control (N=10) | 117.36 mmHg | Standard Error 4.2 |
| Caffeine 300 mg | Systolic and Diastolic Blood Pressure | DBP Cocaine (N=13) | 82.81 mmHg | Standard Error 1.74 |
| Caffeine 300 mg | Systolic and Diastolic Blood Pressure | DBP Control (N=10) | 77.94 mmHg | Standard Error 1.42 |
| Amphetamine 20 mg | Systolic and Diastolic Blood Pressure | DBP Cocaine (N=13) | 78.16 mmHg | Standard Error 1.56 |
| Amphetamine 20 mg | Systolic and Diastolic Blood Pressure | SBP Control (N=10) | 119.27 mmHg | Standard Error 2.13 |
| Amphetamine 20 mg | Systolic and Diastolic Blood Pressure | SBP Cocaine (N=13) | 120.30 mmHg | Standard Error 1.58 |
| Amphetamine 20 mg | Systolic and Diastolic Blood Pressure | DBP Control (N=10) | 77.83 mmHg | Standard Error 1.45 |
Primary
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.
Time frame: Immediately after dose
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Visual Analog Scale Subjective Rating of Drug Effects | Tension: Control (N=10) | 1.05 units on a scale | Standard Error 0.38 |
| Placebo | Visual Analog Scale Subjective Rating of Drug Effects | Tension: Cocaine (N=13) | 1.63 units on a scale | Standard Error 0.62 |
| Placebo | Visual Analog Scale Subjective Rating of Drug Effects | Elation: Cocaine (N=13) | 25.99 units on a scale | Standard Error 6.01 |
| Placebo | Visual Analog Scale Subjective Rating of Drug Effects | Anxious: Cocaine (N=13) | 19.64 units on a scale | Standard Error 6.17 |
| Placebo | Visual Analog Scale Subjective Rating of Drug Effects | Elation: Control (N=10) | 8.65 units on a scale | Standard Error 5.33 |
| Placebo | Visual Analog Scale Subjective Rating of Drug Effects | Depression: Control (N=10) | 0.10 units on a scale | Standard Error 0.1 |
| Placebo | Visual Analog Scale Subjective Rating of Drug Effects | Anxious: Control (N=10) | 10.15 units on a scale | Standard Error 5.31 |
| Placebo | Visual Analog Scale Subjective Rating of Drug Effects | Vigor: Control (N=10) | 8.25 units on a scale | Standard Error 2.06 |
| Placebo | Visual Analog Scale Subjective Rating of Drug Effects | Fatigue: Cocaine (N=13) | 0.68 units on a scale | Standard Error 0.32 |
| Placebo | Visual Analog Scale Subjective Rating of Drug Effects | Depression: Cocaine (N=13) | 1.05 units on a scale | Standard Error 0.54 |
| Placebo | Visual Analog Scale Subjective Rating of Drug Effects | Fatigue: Control (N=10) | 3.85 units on a scale | Standard Error 1.37 |
| Placebo | Visual Analog Scale Subjective Rating of Drug Effects | Vigor: Cocaine (N=13) | 10.42 units on a scale | Standard Error 1.54 |
| Caffeine 150 Mg | Visual Analog Scale Subjective Rating of Drug Effects | Anxious: Control (N=10) | 10.45 units on a scale | Standard Error 5.69 |
| Caffeine 150 Mg | Visual Analog Scale Subjective Rating of Drug Effects | Depression: Cocaine (N=13) | 0.62 units on a scale | Standard Error 0.47 |
| Caffeine 150 Mg | Visual Analog Scale Subjective Rating of Drug Effects | Tension: Control (N=10) | 1.60 units on a scale | Standard Error 0.53 |
| Caffeine 150 Mg | Visual Analog Scale Subjective Rating of Drug Effects | Elation: Cocaine (N=13) | 32.54 units on a scale | Standard Error 7.62 |
| Caffeine 150 Mg | Visual Analog Scale Subjective Rating of Drug Effects | Tension: Cocaine (N=13) | 0.96 units on a scale | Standard Error 0.57 |
| Caffeine 150 Mg | Visual Analog Scale Subjective Rating of Drug Effects | Fatigue: Control (N=10) | 3.00 units on a scale | Standard Error 1.48 |
| Caffeine 150 Mg | Visual Analog Scale Subjective Rating of Drug Effects | Vigor: Cocaine (N=13) | 10.85 units on a scale | Standard Error 1.59 |
| Caffeine 150 Mg | Visual Analog Scale Subjective Rating of Drug Effects | Depression: Control (N=10) | 0.10 units on a scale | Standard Error 0.1 |
| Caffeine 150 Mg | Visual Analog Scale Subjective Rating of Drug Effects | Elation: Control (N=10) | 9.85 units on a scale | Standard Error 5.32 |
| Caffeine 150 Mg | Visual Analog Scale Subjective Rating of Drug Effects | Anxious: Cocaine (N=13) | 21.35 units on a scale | Standard Error 6.01 |
| Caffeine 150 Mg | Visual Analog Scale Subjective Rating of Drug Effects | Fatigue: Cocaine (N=13) | 0.54 units on a scale | Standard Error 0.25 |
| Caffeine 150 Mg | Visual Analog Scale Subjective Rating of Drug Effects | Vigor: Control (N=10) | 8.50 units on a scale | Standard Error 1.92 |
| Caffeine 300 mg | Visual Analog Scale Subjective Rating of Drug Effects | Elation: Cocaine (N=13) | 21.65 units on a scale | Standard Error 5.68 |
| Caffeine 300 mg | Visual Analog Scale Subjective Rating of Drug Effects | Fatigue: Cocaine (N=13) | 1.69 units on a scale | Standard Error 0.71 |
| Caffeine 300 mg | Visual Analog Scale Subjective Rating of Drug Effects | Depression: Control (N=10) | 0.41 units on a scale | Standard Error 0.3 |
| Caffeine 300 mg | Visual Analog Scale Subjective Rating of Drug Effects | Depression: Cocaine (N=13) | 1.96 units on a scale | Standard Error 1.12 |
| Caffeine 300 mg | Visual Analog Scale Subjective Rating of Drug Effects | Tension: Cocaine (N=13) | 2.38 units on a scale | Standard Error 0.94 |
| Caffeine 300 mg | Visual Analog Scale Subjective Rating of Drug Effects | Anxious: Control (N=10) | 8.50 units on a scale | Standard Error 4.91 |
| Caffeine 300 mg | Visual Analog Scale Subjective Rating of Drug Effects | Anxious: Cocaine (N=13) | 25.27 units on a scale | Standard Error 7.12 |
| Caffeine 300 mg | Visual Analog Scale Subjective Rating of Drug Effects | Elation: Control (N=10) | 13.65 units on a scale | Standard Error 6.1 |
| Caffeine 300 mg | Visual Analog Scale Subjective Rating of Drug Effects | Vigor: Control (N=10) | 9.78 units on a scale | Standard Error 1.98 |
| Caffeine 300 mg | Visual Analog Scale Subjective Rating of Drug Effects | Vigor: Cocaine (N=13) | 9.27 units on a scale | Standard Error 1.6 |
| Caffeine 300 mg | Visual Analog Scale Subjective Rating of Drug Effects | Tension: Control (N=10) | 1.62 units on a scale | Standard Error 0.6 |
| Caffeine 300 mg | Visual Analog Scale Subjective Rating of Drug Effects | Fatigue: Control (N=10) | 3.44 units on a scale | Standard Error 1.64 |
| Amphetamine 20 mg | Visual Analog Scale Subjective Rating of Drug Effects | Depression: Cocaine (N=13) | 1.10 units on a scale | Standard Error 0.51 |
| Amphetamine 20 mg | Visual Analog Scale Subjective Rating of Drug Effects | Tension: Cocaine (N=13) | 1.88 units on a scale | Standard Error 0.61 |
| Amphetamine 20 mg | Visual Analog Scale Subjective Rating of Drug Effects | Elation: Control (N=10) | 10.43 units on a scale | Standard Error 4.48 |
| Amphetamine 20 mg | Visual Analog Scale Subjective Rating of Drug Effects | Elation: Cocaine (N=13) | 25.71 units on a scale | Standard Error 6.42 |
| Amphetamine 20 mg | Visual Analog Scale Subjective Rating of Drug Effects | Anxious: Control (N=10) | 11.68 units on a scale | Standard Error 4.62 |
| Amphetamine 20 mg | Visual Analog Scale Subjective Rating of Drug Effects | Anxious: Cocaine (N=13) | 21.71 units on a scale | Standard Error 5.43 |
| Amphetamine 20 mg | Visual Analog Scale Subjective Rating of Drug Effects | Vigor: Control (N=10) | 8.28 units on a scale | Standard Error 2.01 |
| Amphetamine 20 mg | Visual Analog Scale Subjective Rating of Drug Effects | Vigor: Cocaine (N=13) | 10.31 units on a scale | Standard Error 1.33 |
| Amphetamine 20 mg | Visual Analog Scale Subjective Rating of Drug Effects | Tension: Control (N=10) | 1.53 units on a scale | Standard Error 0.48 |
| Amphetamine 20 mg | Visual Analog Scale Subjective Rating of Drug Effects | Fatigue: Control (N=10) | 3.60 units on a scale | Standard Error 1.07 |
| Amphetamine 20 mg | Visual Analog Scale Subjective Rating of Drug Effects | Fatigue: Cocaine (N=13) | 1.17 units on a scale | Standard Error 0.36 |
| Amphetamine 20 mg | Visual Analog Scale Subjective Rating of Drug Effects | Depression: Control (N=10) | 0.10 units on a scale | Standard Error 0.06 |
Secondary
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.
Time frame: 75 minutes after dose
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Probabalistic Feedback Selection Task | Control (N=10) | 0.56 accuracy | Standard Error 0.02 |
| Placebo | Probabalistic Feedback Selection Task | Cocaine (N=13) | 0.54 accuracy | Standard Error 0.01 |
| Caffeine 150 Mg | Probabalistic Feedback Selection Task | Cocaine (N=13) | 0.56 accuracy | Standard Error 0.02 |
| Caffeine 150 Mg | Probabalistic Feedback Selection Task | Control (N=10) | 0.55 accuracy | Standard Error 0.03 |
| Caffeine 300 mg | Probabalistic Feedback Selection Task | Cocaine (N=13) | 0.58 accuracy | Standard Error 0.02 |
| Caffeine 300 mg | Probabalistic Feedback Selection Task | Control (N=10) | 0.56 accuracy | Standard Error 0.02 |
| Amphetamine 20 mg | Probabalistic Feedback Selection Task | Cocaine (N=13) | 0.56 accuracy | Standard Error 0.02 |
| Amphetamine 20 mg | Probabalistic Feedback Selection Task | Control (N=10) | 0.61 accuracy | Standard Error 0.02 |
Secondary
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.
Time frame: 30 minutes prior to dose, 30/90/150 minutes post dose.
Population: Assessment was not performed for amphetamine intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Saliva Caffeine and Paraxanthine Levels | Caffeine 150 min Control (N=10) | 984 ng/mL | Standard Error 601 |
| Placebo | Saliva Caffeine and Paraxanthine Levels | Parathanxine 90 min Control (N=10) | 411 ng/mL | Standard Error 219 |
| Placebo | Saliva Caffeine and Paraxanthine Levels | Caffeine 30 min Cocaine (N=11) | 780 ng/mL | Standard Error 510 |
| Placebo | Saliva Caffeine and Paraxanthine Levels | Parathanxine 30 min Cocaine (N=11) | 320 ng/mL | Standard Error 275 |
| Placebo | Saliva Caffeine and Paraxanthine Levels | Parathanxine 30 min Control (N=10) | 410 ng/mL | Standard Error 240 |
| Placebo | Saliva Caffeine and Paraxanthine Levels | Caffeine 90 min Cocaine (N=11) | 625 ng/mL | Standard Error 410 |
| Placebo | Saliva Caffeine and Paraxanthine Levels | Caffeine 30 min Control (N=10) | 983 ng/mL | Standard Error 440 |
| Placebo | Saliva Caffeine and Paraxanthine Levels | Parathanxine -30 min Control (N=10) | 440 ng/mL | Standard Error 155 |
| Placebo | Saliva Caffeine and Paraxanthine Levels | Caffeine 150 min Cocaine (N=11) | 510 ng/mL | Standard Error 322 |
| Placebo | Saliva Caffeine and Paraxanthine Levels | Parathanxine 150 min Cocaine (N=11) | 296 ng/mL | Standard Error 252 |
| Placebo | Saliva Caffeine and Paraxanthine Levels | Parathanxine -30 min Cocaine (N=11) | 334 ng/mL | Standard Error 205 |
| Placebo | Saliva Caffeine and Paraxanthine Levels | Caffeine 90 min Control (N=10) | 984 ng/mL | Standard Error 445 |
| Placebo | Saliva Caffeine and Paraxanthine Levels | Parathanxine 90 min Cocaine (N=11) | 321 ng/mL | Standard Error 248 |
| Placebo | Saliva Caffeine and Paraxanthine Levels | Caffeine -30 min Control (N=10) | 1000 ng/mL | Standard Error 490 |
| Placebo | Saliva Caffeine and Paraxanthine Levels | Parathanxine 150 min Control (N=10) | 410 ng/mL | Standard Error 143 |
| Placebo | Saliva Caffeine and Paraxanthine Levels | Caffeine -30 min Cocaine (N=11) | 990 ng/mL | Standard Error 920 |
| Caffeine 150 Mg | Saliva Caffeine and Paraxanthine Levels | Parathanxine 150 min Cocaine (N=11) | 605 ng/mL | Standard Error 247 |
| Caffeine 150 Mg | Saliva Caffeine and Paraxanthine Levels | Parathanxine -30 min Control (N=10) | 274 ng/mL | Standard Error 140 |
| Caffeine 150 Mg | Saliva Caffeine and Paraxanthine Levels | Caffeine -30 min Control (N=10) | 510 ng/mL | Standard Error 470 |
| Caffeine 150 Mg | Saliva Caffeine and Paraxanthine Levels | Caffeine 30 min Control (N=10) | 2715 ng/mL | Standard Error 1110 |
| Caffeine 150 Mg | Saliva Caffeine and Paraxanthine Levels | Caffeine 90 min Control (N=10) | 2225 ng/mL | Standard Error 995 |
| Caffeine 150 Mg | Saliva Caffeine and Paraxanthine Levels | Caffeine 150 min Control (N=10) | 1910 ng/mL | Standard Error 898 |
| Caffeine 150 Mg | Saliva Caffeine and Paraxanthine Levels | Caffeine -30 min Cocaine (N=11) | 998 ng/mL | Standard Error 820 |
| Caffeine 150 Mg | Saliva Caffeine and Paraxanthine Levels | Caffeine 30 min Cocaine (N=11) | 2125 ng/mL | Standard Error 1001 |
| Caffeine 150 Mg | Saliva Caffeine and Paraxanthine Levels | Caffeine 90 min Cocaine (N=11) | 2077 ng/mL | Standard Error 874 |
| Caffeine 150 Mg | Saliva Caffeine and Paraxanthine Levels | Caffeine 150 min Cocaine (N=11) | 1909 ng/mL | Standard Error 605 |
| Caffeine 150 Mg | Saliva Caffeine and Paraxanthine Levels | Parathanxine 30 min Control (N=10) | 301 ng/mL | Standard Error 238 |
| Caffeine 150 Mg | Saliva Caffeine and Paraxanthine Levels | Parathanxine 90 min Control (N=10) | 402 ng/mL | Standard Error 155 |
| Caffeine 150 Mg | Saliva Caffeine and Paraxanthine Levels | Parathanxine 150 min Control (N=10) | 411 ng/mL | Standard Error 145 |
| Caffeine 150 Mg | Saliva Caffeine and Paraxanthine Levels | Parathanxine -30 min Cocaine (N=11) | 401 ng/mL | Standard Error 197 |
| Caffeine 150 Mg | Saliva Caffeine and Paraxanthine Levels | Parathanxine 30 min Cocaine (N=11) | 465 ng/mL | Standard Error 185 |
| Caffeine 150 Mg | Saliva Caffeine and Paraxanthine Levels | Parathanxine 90 min Cocaine (N=11) | 601 ng/mL | Standard Error 233 |
| Caffeine 300 mg | Saliva Caffeine and Paraxanthine Levels | Parathanxine 150 min Cocaine (N=11) | 1014 ng/mL | Standard Error 255 |
| Caffeine 300 mg | Saliva Caffeine and Paraxanthine Levels | Parathanxine 90 min Control (N=10) | 397 ng/mL | Standard Error 110 |
| Caffeine 300 mg | Saliva Caffeine and Paraxanthine Levels | Caffeine 150 min Control (N=10) | 3270 ng/mL | Standard Error 901 |
| Caffeine 300 mg | Saliva Caffeine and Paraxanthine Levels | Caffeine 90 min Control (N=10) | 3510 ng/mL | Standard Error 1001 |
| Caffeine 300 mg | Saliva Caffeine and Paraxanthine Levels | Parathanxine 150 min Control (N=10) | 462 ng/mL | Standard Error 215 |
| Caffeine 300 mg | Saliva Caffeine and Paraxanthine Levels | Caffeine 30 min Control (N=10) | 2895 ng/mL | Standard Error 998 |
| Caffeine 300 mg | Saliva Caffeine and Paraxanthine Levels | Parathanxine 90 min Cocaine (N=11) | 985 ng/mL | Standard Error 245 |
| Caffeine 300 mg | Saliva Caffeine and Paraxanthine Levels | Parathanxine -30 min Cocaine (N=11) | 408 ng/mL | Standard Error 240 |
| Caffeine 300 mg | Saliva Caffeine and Paraxanthine Levels | Caffeine -30 min Control (N=10) | 335 ng/mL | Standard Error 110 |
| Caffeine 300 mg | Saliva Caffeine and Paraxanthine Levels | Parathanxine -30 min Control (N=10) | 198 ng/mL | Standard Error 92 |
| Caffeine 300 mg | Saliva Caffeine and Paraxanthine Levels | Caffeine 150 min Cocaine (N=11) | 3205 ng/mL | Standard Error 697 |
| Caffeine 300 mg | Saliva Caffeine and Paraxanthine Levels | Caffeine 90 min Cocaine (N=11) | 3720 ng/mL | Standard Error 911 |
| Caffeine 300 mg | Saliva Caffeine and Paraxanthine Levels | Caffeine 30 min Cocaine (N=11) | 3510 ng/mL | Standard Error 1220 |
| Caffeine 300 mg | Saliva Caffeine and Paraxanthine Levels | Parathanxine 30 min Cocaine (N=11) | 656 ng/mL | Standard Error 280 |
| Caffeine 300 mg | Saliva Caffeine and Paraxanthine Levels | Parathanxine 30 min Control (N=10) | 202 ng/mL | Standard Error 101 |
| Caffeine 300 mg | Saliva Caffeine and Paraxanthine Levels | Caffeine -30 min Cocaine (N=11) | 1201 ng/mL | Standard Error 997 |