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| ID | Type | Description | Link |
|---|---|---|---|
| P50DA009262 | U.S. NIH Grant/Contract | View source | |
| DPMCDA |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| The University of Texas Health Science Center, Houston | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Caffeine 150 mg | Experimental | Caffeine 150 mg |
|
| 2 Placebo | Placebo Comparator | Placebo |
|
| 3 Amphetamine | Experimental | Amphetamine |
|
| 4 Caffeine 300 mg | Experimental | Caffeine 300 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caffeine 150 MG | Drug | Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick G Moeller, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center, Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25414797 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cocaine Users | 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 |
| FG001 | Control Participants | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Control Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | units on a scale | Immediately after dose |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 Caffeine | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| F. Gerard Moeller | Virginia Commonwealth University | 804-828-4134 | fgmoeller@vcu.edu |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| D019966 | Substance-Related Disorders |
| D007175 | Impulsive Behavior |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D002110 | Caffeine |
| D000661 | Amphetamine |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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|
| Placebo | Drug | 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 | Drug | Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion |
|
| Caffeine 300 MG | Drug | Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion |
|
|
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. |
Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Caffeine 300 mg |
| OG003 | Amphetamine 20 mg | Amphetamine 20 mg |
|
|
| Primary | Systolic and Diastolic Blood Pressure | Sitting Blood Pressure | Posted | Mean | Standard Error | mmHg | Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours |
|
|
|
| Primary | Heart Rate | Sitting heart rate | Posted | Mean | Standard Error | Beats per minute | Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours |
|
|
|
| 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) | Posted | Mean | Standard Error | units on a scale | Immediately after dose |
|
|
|
| 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. | Posted | Mean | Standard Error | units on a scale | Immediately after dose |
|
|
|
| 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. | Posted | Mean | Standard Error | accuracy | 75 minutes after dose |
|
|
|
| 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. | Assessment was not performed for amphetamine intervention | Posted | Mean | Standard Error | ng/mL | 30 minutes prior to dose, 30/90/150 minutes post dose. |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | 2 Placebo | 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 | 0 | 23 | 0 | 23 |
| EG002 | 3 Amphetamine | 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 | 0 | 23 | 0 | 23 |
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| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| SBP Cocaine (N=13) |
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| DBP Control (N=10) |
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| DBP Cocaine (N=13) |
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| Cocaine (N=13) |
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| PCAG: Cocaine (N=13) |
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| A: Control (N=10) |
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| A: Cocaine (N=13) |
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| BG: Control (N=10) |
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| BG: Cocaine (N=13) |
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| MGB: Control (N=10) |
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| MGB: Cocaine (N=13) |
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| LSD: Control (N=10) |
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| LSD: Cocaine (N=13) |
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| Feel effects:Cocaine (N=13) |
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| Like effects:Control (N=10) |
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| Like effects:Cocaine (N=13) |
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| High:Control (N=10) |
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| High:Cocaine (N=13) |
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| Like more:Control (N=10) |
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| Like more:Cocaine (N=13) |
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| Cocaine (N=13) |
|
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| Caffeine 90 min Control (N=10) |
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| Caffeine 150 min Control (N=10) |
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| Caffeine -30 min Cocaine (N=11) |
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| Caffeine 30 min Cocaine (N=11) |
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| Caffeine 90 min Cocaine (N=11) |
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| Caffeine 150 min Cocaine (N=11) |
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| Parathanxine -30 min Control (N=10) |
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| Parathanxine 30 min Control (N=10) |
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| Parathanxine 90 min Control (N=10) |
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| Parathanxine 150 min Control (N=10) |
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| Parathanxine -30 min Cocaine (N=11) |
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| Parathanxine 30 min Cocaine (N=11) |
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| Parathanxine 90 min Cocaine (N=11) |
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| Parathanxine 150 min Cocaine (N=11) |
|