Trial Outcomes & Findings for Caffeine and Cocaine (NCT NCT00733993)
NCT ID: NCT00733993
Last Updated: 2017-03-22
Results Overview
Visual Analog Scale Rating. Scores range from 0 to 100 with higher scores meaning greater intensity of response being rated.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Immediately after dose
Results posted on
2017-03-22
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
10
|
|
Overall Study
COMPLETED
|
13
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Caffeine and Cocaine
Baseline characteristics by cohort
| Measure |
Cocaine Users
n=13 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
|
Control Participants
n=10 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
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
10 participants
n=107 Participants
|
23 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Immediately after doseVisual Analog Scale Rating. Scores range from 0 to 100 with higher scores meaning greater intensity of response being rated.
Outcome measures
| Measure |
Placebo
n=23 Participants
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
|
Caffeine 150 Mg
n=23 Participants
150 MG of Caffeine
|
Caffeine 300 mg
n=23 Participants
Caffeine 300 mg
|
Amphetamine 20 mg
n=23 Participants
Amphetamine 20 mg
|
|---|---|---|---|---|
|
Visual Analog Scale Subjective Rating of Drug Effects
Elation: Control (N=10)
|
8.65 units on a scale
Standard Error 5.33
|
9.85 units on a scale
Standard Error 5.32
|
13.65 units on a scale
Standard Error 6.1
|
10.43 units on a scale
Standard Error 4.48
|
|
Visual Analog Scale Subjective Rating of Drug Effects
Elation: Cocaine (N=13)
|
25.99 units on a scale
Standard Error 6.01
|
32.54 units on a scale
Standard Error 7.62
|
21.65 units on a scale
Standard Error 5.68
|
25.71 units on a scale
Standard Error 6.42
|
|
Visual Analog Scale Subjective Rating of Drug Effects
Anxious: Cocaine (N=13)
|
19.64 units on a scale
Standard Error 6.17
|
21.35 units on a scale
Standard Error 6.01
|
25.27 units on a scale
Standard Error 7.12
|
21.71 units on a scale
Standard Error 5.43
|
|
Visual Analog Scale Subjective Rating of Drug Effects
Fatigue: Control (N=10)
|
3.85 units on a scale
Standard Error 1.37
|
3.00 units on a scale
Standard Error 1.48
|
3.44 units on a scale
Standard Error 1.64
|
3.60 units on a scale
Standard Error 1.07
|
|
Visual Analog Scale Subjective Rating of Drug Effects
Anxious: Control (N=10)
|
10.15 units on a scale
Standard Error 5.31
|
10.45 units on a scale
Standard Error 5.69
|
8.50 units on a scale
Standard Error 4.91
|
11.68 units on a scale
Standard Error 4.62
|
|
Visual Analog Scale Subjective Rating of Drug Effects
Vigor: Control (N=10)
|
8.25 units on a scale
Standard Error 2.06
|
8.50 units on a scale
Standard Error 1.92
|
9.78 units on a scale
Standard Error 1.98
|
8.28 units on a scale
Standard Error 2.01
|
|
Visual Analog Scale Subjective Rating of Drug Effects
Vigor: Cocaine (N=13)
|
10.42 units on a scale
Standard Error 1.54
|
10.85 units on a scale
Standard Error 1.59
|
9.27 units on a scale
Standard Error 1.60
|
10.31 units on a scale
Standard Error 1.33
|
|
Visual Analog Scale Subjective Rating of Drug Effects
Tension: Control (N=10)
|
1.05 units on a scale
Standard Error 0.38
|
1.60 units on a scale
Standard Error 0.53
|
1.62 units on a scale
Standard Error 0.60
|
1.53 units on a scale
Standard Error 0.48
|
|
Visual Analog Scale Subjective Rating of Drug Effects
Tension: Cocaine (N=13)
|
1.63 units on a scale
Standard Error 0.62
|
0.96 units on a scale
Standard Error 0.57
|
2.38 units on a scale
Standard Error 0.94
|
1.88 units on a scale
Standard Error 0.61
|
|
Visual Analog Scale Subjective Rating of Drug Effects
Fatigue: Cocaine (N=13)
|
0.68 units on a scale
Standard Error 0.32
|
0.54 units on a scale
Standard Error 0.25
|
1.69 units on a scale
Standard Error 0.71
|
1.17 units on a scale
Standard Error 0.36
|
|
Visual Analog Scale Subjective Rating of Drug Effects
Depression: Control (N=10)
|
0.10 units on a scale
Standard Error 0.10
|
0.10 units on a scale
Standard Error 0.10
|
0.41 units on a scale
Standard Error 0.30
|
0.10 units on a scale
Standard Error 0.06
|
|
Visual Analog Scale Subjective Rating of Drug Effects
Depression: Cocaine (N=13)
|
1.05 units on a scale
Standard Error 0.54
|
0.62 units on a scale
Standard Error 0.47
|
1.96 units on a scale
Standard Error 1.12
|
1.10 units on a scale
Standard Error 0.51
|
PRIMARY outcome
Timeframe: Average across 7 time points: Immediately after dose and every 30 minutes for 3 hoursSitting Blood Pressure
Outcome measures
| Measure |
Placebo
n=23 Participants
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
|
Caffeine 150 Mg
n=23 Participants
150 MG of Caffeine
|
Caffeine 300 mg
n=23 Participants
Caffeine 300 mg
|
Amphetamine 20 mg
n=23 Participants
Amphetamine 20 mg
|
|---|---|---|---|---|
|
Systolic and Diastolic Blood Pressure
SBP Control (N=10)
|
115.64 mmHg
Standard Error 3.41
|
115.9 mmHg
Standard Error 4.07
|
117.36 mmHg
Standard Error 4.2
|
119.27 mmHg
Standard Error 2.13
|
|
Systolic and Diastolic Blood Pressure
SBP Cocaine (N=13)
|
120.18 mmHg
Standard Error 1.40
|
122.10 mmHg
Standard Error 1.81
|
123.84 mmHg
Standard Error 2.18
|
120.30 mmHg
Standard Error 1.58
|
|
Systolic and Diastolic Blood Pressure
DBP Control (N=10)
|
74.82 mmHg
Standard Error 2.78
|
75.33 mmHg
Standard Error 2.72
|
77.94 mmHg
Standard Error 1.42
|
77.83 mmHg
Standard Error 1.45
|
|
Systolic and Diastolic Blood Pressure
DBP Cocaine (N=13)
|
79.66 mmHg
Standard Error 3.01
|
79.98 mmHg
Standard Error 1.79
|
82.81 mmHg
Standard Error 1.74
|
78.16 mmHg
Standard Error 1.56
|
PRIMARY outcome
Timeframe: Average across 7 time points: Immediately after dose and every 30 minutes for 3 hoursSitting heart rate
Outcome measures
| Measure |
Placebo
n=23 Participants
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
|
Caffeine 150 Mg
n=23 Participants
150 MG of Caffeine
|
Caffeine 300 mg
n=23 Participants
Caffeine 300 mg
|
Amphetamine 20 mg
n=23 Participants
Amphetamine 20 mg
|
|---|---|---|---|---|
|
Heart Rate
Control (N=10)
|
66.10 Beats per minute
Standard Error 1.88
|
62.47 Beats per minute
Standard Error 2.09
|
61.33 Beats per minute
Standard Error 1.67
|
65.55 Beats per minute
Standard Error 1.23
|
|
Heart Rate
Cocaine (N=13)
|
63.08 Beats per minute
Standard Error 2.11
|
62.60 Beats per minute
Standard Error 3.00
|
61.57 Beats per minute
Standard Error 1.40
|
63.51 Beats per minute
Standard Error 2.99
|
PRIMARY outcome
Timeframe: Immediately after doseAddiction 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)
Outcome measures
| Measure |
Placebo
n=23 Participants
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
|
Caffeine 150 Mg
n=23 Participants
150 MG of Caffeine
|
Caffeine 300 mg
n=23 Participants
Caffeine 300 mg
|
Amphetamine 20 mg
n=23 Participants
Amphetamine 20 mg
|
|---|---|---|---|---|
|
Addiction Research Center Inventory Subjective Rating of Drug Effects
LSD: Control (N=10)
|
1.78 units on a scale
Standard Error 0.44
|
2.43 units on a scale
Standard Error 0.56
|
1.23 units on a scale
Standard Error 0.41
|
1.70 units on a scale
Standard Error 0.41
|
|
Addiction Research Center Inventory Subjective Rating of Drug Effects
LSD: Cocaine (N=13)
|
0.89 units on a scale
Standard Error 0.47
|
0.48 units on a scale
Standard Error 0.49
|
1.05 units on a scale
Standard Error 0.49
|
0.98 units on a scale
Standard Error 0.45
|
|
Addiction Research Center Inventory Subjective Rating of Drug Effects
PCAG: Control (N=10)
|
3.87 units on a scale
Standard Error 0.82
|
3.62 units on a scale
Standard Error 0.83
|
3.52 units on a scale
Standard Error 0.79
|
3.64 units on a scale
Standard Error 0.71
|
|
Addiction Research Center Inventory Subjective Rating of Drug Effects
PCAG: Cocaine (N=13)
|
1.95 units on a scale
Standard Error 0.58
|
1.83 units on a scale
Standard Error 0.68
|
2.95 units on a scale
Standard Error 0.82
|
2.43 units on a scale
Standard Error 0.67
|
|
Addiction Research Center Inventory Subjective Rating of Drug Effects
A: Control (N=10)
|
3.20 units on a scale
Standard Error 0.51
|
3.60 units on a scale
Standard Error 0.68
|
3.80 units on a scale
Standard Error 0.59
|
3.22 units on a scale
Standard Error 0.38
|
|
Addiction Research Center Inventory Subjective Rating of Drug Effects
A: Cocaine (N=13)
|
3.30 units on a scale
Standard Error 0.51
|
3.39 units on a scale
Standard Error 0.54
|
3.19 units on a scale
Standard Error 0.44
|
3.69 units on a scale
Standard Error 0.45
|
|
Addiction Research Center Inventory Subjective Rating of Drug Effects
BG: Control (N=10)
|
6.00 units on a scale
Standard Error 0.39
|
6.35 units on a scale
Standard Error 0.56
|
6.05 units on a scale
Standard Error 0.57
|
5.83 units on a scale
Standard Error 0.36
|
|
Addiction Research Center Inventory Subjective Rating of Drug Effects
BG: Cocaine (N=13)
|
5.69 units on a scale
Standard Error 0.34
|
5.77 units on a scale
Standard Error 0.37
|
5.07 units on a scale
Standard Error 0.61
|
5.57 units on a scale
Standard Error 0.51
|
|
Addiction Research Center Inventory Subjective Rating of Drug Effects
MGB: Control (N=10)
|
4.09 units on a scale
Standard Error 1.26
|
4.34 units on a scale
Standard Error 1.31
|
5.14 units on a scale
Standard Error 1.37
|
4.04 units on a scale
Standard Error 1.28
|
|
Addiction Research Center Inventory Subjective Rating of Drug Effects
MGB: Cocaine (N=13)
|
5.29 units on a scale
Standard Error 1.13
|
5.62 units on a scale
Standard Error 1.23
|
4.31 units on a scale
Standard Error 0.96
|
5.18 units on a scale
Standard Error 1.00
|
PRIMARY outcome
Timeframe: Immediately after doseAssessments measured using a 4 item Drug Effects Questionnaire (DEQ) Ranges from 0 to 100 with higher numbers showing greater effect for each scale.
Outcome measures
| Measure |
Placebo
n=23 Participants
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
|
Caffeine 150 Mg
n=23 Participants
150 MG of Caffeine
|
Caffeine 300 mg
n=23 Participants
Caffeine 300 mg
|
Amphetamine 20 mg
n=23 Participants
Amphetamine 20 mg
|
|---|---|---|---|---|
|
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
|
35.62 units on a scale
Standard Error 6.89
|
52.17 units on a scale
Standard Error 6.95
|
42.25 units on a scale
Standard Error 5.74
|
|
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
|
20.25 units on a scale
Standard Error 6.31
|
9.45 units on a scale
Standard Error 4.97
|
11.37 units on a scale
Standard Error 4.93
|
|
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
|
25.68 units on a scale
Standard Error 8.99
|
28.71 units on a scale
Standard Error 8.48
|
26.16 units on a scale
Standard Error 8.69
|
|
Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects
Feel effects:Cocaine (N=13)
|
17.30 units on a scale
Standard Error 5.80
|
20.73 units on a scale
Standard Error 5.95
|
17.62 units on a scale
Standard Error 5.91
|
18.68 units on a scale
Standard Error 6.08
|
|
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
|
39.94 units on a scale
Standard Error 10.55
|
43.75 units on a scale
Standard Error 7.21
|
32.04 units on a scale
Standard Error 8.63
|
|
Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects
High:Control (N=10)
|
10.77 units on a scale
Standard Error 5.23
|
12.17 units on a scale
Standard Error 5.59
|
7.17 units on a scale
Standard Error 4.16
|
7.17 units on a scale
Standard Error 3.95
|
|
Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects
High:Cocaine (N=13)
|
14.35 units on a scale
Standard Error 5.45
|
16.14 units on a scale
Standard Error 5.67
|
15.87 units on a scale
Standard Error 5.78
|
14.64 units on a scale
Standard Error 5.44
|
|
Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects
Like more:Control (N=10)
|
25.77 units on a scale
Standard Error 7.20
|
25.62 units on a scale
Standard Error 6.54
|
32.92 units on a scale
Standard Error 7.01
|
25.65 units on a scale
Standard Error 6.08
|
SECONDARY outcome
Timeframe: 75 minutes after doseAccuracy on a range from 0 to 1 of correctly performing a learning task, with 1 being the highest degree of accuracy.
Outcome measures
| Measure |
Placebo
n=23 Participants
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
|
Caffeine 150 Mg
n=23 Participants
150 MG of Caffeine
|
Caffeine 300 mg
n=23 Participants
Caffeine 300 mg
|
Amphetamine 20 mg
n=23 Participants
Amphetamine 20 mg
|
|---|---|---|---|---|
|
Probabalistic Feedback Selection Task
Cocaine (N=13)
|
0.54 accuracy
Standard Error 0.01
|
0.56 accuracy
Standard Error 0.02
|
0.58 accuracy
Standard Error 0.02
|
0.56 accuracy
Standard Error 0.02
|
|
Probabalistic Feedback Selection Task
Control (N=10)
|
0.56 accuracy
Standard Error 0.02
|
0.55 accuracy
Standard Error 0.03
|
0.56 accuracy
Standard Error 0.02
|
0.61 accuracy
Standard Error 0.02
|
SECONDARY outcome
Timeframe: 30 minutes prior to dose, 30/90/150 minutes post dose.Population: Assessment was not performed for amphetamine intervention
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.
Outcome measures
| Measure |
Placebo
n=21 Participants
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
|
Caffeine 150 Mg
n=21 Participants
150 MG of Caffeine
|
Caffeine 300 mg
n=21 Participants
Caffeine 300 mg
|
Amphetamine 20 mg
Amphetamine 20 mg
|
|---|---|---|---|---|
|
Saliva Caffeine and Paraxanthine Levels
Caffeine -30 min Control (N=10)
|
1000 ng/mL
Standard Error 490
|
510 ng/mL
Standard Error 470
|
335 ng/mL
Standard Error 110
|
—
|
|
Saliva Caffeine and Paraxanthine Levels
Parathanxine 30 min Control (N=10)
|
410 ng/mL
Standard Error 240
|
301 ng/mL
Standard Error 238
|
202 ng/mL
Standard Error 101
|
—
|
|
Saliva Caffeine and Paraxanthine Levels
Parathanxine 90 min Control (N=10)
|
411 ng/mL
Standard Error 219
|
402 ng/mL
Standard Error 155
|
397 ng/mL
Standard Error 110
|
—
|
|
Saliva Caffeine and Paraxanthine Levels
Parathanxine 150 min Cocaine (N=11)
|
296 ng/mL
Standard Error 252
|
605 ng/mL
Standard Error 247
|
1014 ng/mL
Standard Error 255
|
—
|
|
Saliva Caffeine and Paraxanthine Levels
Caffeine 30 min Control (N=10)
|
983 ng/mL
Standard Error 440
|
2715 ng/mL
Standard Error 1110
|
2895 ng/mL
Standard Error 998
|
—
|
|
Saliva Caffeine and Paraxanthine Levels
Caffeine 90 min Control (N=10)
|
984 ng/mL
Standard Error 445
|
2225 ng/mL
Standard Error 995
|
3510 ng/mL
Standard Error 1001
|
—
|
|
Saliva Caffeine and Paraxanthine Levels
Caffeine 150 min Control (N=10)
|
984 ng/mL
Standard Error 601
|
1910 ng/mL
Standard Error 898
|
3270 ng/mL
Standard Error 901
|
—
|
|
Saliva Caffeine and Paraxanthine Levels
Caffeine -30 min Cocaine (N=11)
|
990 ng/mL
Standard Error 920
|
998 ng/mL
Standard Error 820
|
1201 ng/mL
Standard Error 997
|
—
|
|
Saliva Caffeine and Paraxanthine Levels
Caffeine 30 min Cocaine (N=11)
|
780 ng/mL
Standard Error 510
|
2125 ng/mL
Standard Error 1001
|
3510 ng/mL
Standard Error 1220
|
—
|
|
Saliva Caffeine and Paraxanthine Levels
Caffeine 90 min Cocaine (N=11)
|
625 ng/mL
Standard Error 410
|
2077 ng/mL
Standard Error 874
|
3720 ng/mL
Standard Error 911
|
—
|
|
Saliva Caffeine and Paraxanthine Levels
Caffeine 150 min Cocaine (N=11)
|
510 ng/mL
Standard Error 322
|
1909 ng/mL
Standard Error 605
|
3205 ng/mL
Standard Error 697
|
—
|
|
Saliva Caffeine and Paraxanthine Levels
Parathanxine -30 min Control (N=10)
|
440 ng/mL
Standard Error 155
|
274 ng/mL
Standard Error 140
|
198 ng/mL
Standard Error 92
|
—
|
|
Saliva Caffeine and Paraxanthine Levels
Parathanxine 150 min Control (N=10)
|
410 ng/mL
Standard Error 143
|
411 ng/mL
Standard Error 145
|
462 ng/mL
Standard Error 215
|
—
|
|
Saliva Caffeine and Paraxanthine Levels
Parathanxine -30 min Cocaine (N=11)
|
334 ng/mL
Standard Error 205
|
401 ng/mL
Standard Error 197
|
408 ng/mL
Standard Error 240
|
—
|
|
Saliva Caffeine and Paraxanthine Levels
Parathanxine 30 min Cocaine (N=11)
|
320 ng/mL
Standard Error 275
|
465 ng/mL
Standard Error 185
|
656 ng/mL
Standard Error 280
|
—
|
|
Saliva Caffeine and Paraxanthine Levels
Parathanxine 90 min Cocaine (N=11)
|
321 ng/mL
Standard Error 248
|
601 ng/mL
Standard Error 233
|
985 ng/mL
Standard Error 245
|
—
|
Adverse Events
1 Caffeine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2 Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3 Amphetamine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place