Trial Outcomes & Findings for Phendimetrazine and Cocaine (NCT NCT02233647)

NCT ID: NCT02233647

Last Updated: 2017-09-27

Results Overview

Systolic blood pressure was measured with an automated monitor. Higher values represent greater systolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 11 participants
• Primary outcome timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
• Results posted on: 2017-09-27

Participant Flow

Eleven subjects were enrolled (i.e., signed consent), but only 10 subjects completed. Due to the within-subject nature of this study (i.e., missing data from the 11th subject cannot be analyzed with repeated-measures ANOVA), only data from the 10 subjects who completed the protocol were analyzed and reported.

Participant milestones

Measure	Phendimetrazine Dose Escalation Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Intranasal cocaine (10, 20, 40 and 80 mg) was administered acutely after at least seven days of maintenance on each condition. Intransasal placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo were determined during maintenance on placebo and phendimetrazine.
Overall Study STARTED	11
Overall Study 0 mg Cocaine With 0 mg Phendimetrazine	11
Overall Study 10 mg Cocaine With 0 mg Phendimetrazine	11
Overall Study 20 mg Cocaine With 0 mg Phendimetrazine	10
Overall Study 40 mg Cocaine With 0 mg Phendimetrazine	10
Overall Study 80 mg Cocaine With 0 mg Phendimetrazine	10
Overall Study 0 mg Cocaine With 70 mg Phendimetrazine	10
Overall Study 10 mg Cocaine With 70 mg Phendimetrazine	10
Overall Study 20 mg Cocaine With 70 mg Phendimetrazine	10
Overall Study 40 mg Cocaine With 70 mg Phendimetrazine	10
Overall Study 80 mg Cocaine With 70 mg Phendimetrazine	10
Overall Study 0 mg Cocaine With 140 mg Phendimetrazine	10
Overall Study 10 mg Cocaine with140 mg Phendimetrazine	10
Overall Study 20 mg Cocaine with140 mg Phendimetrazine	10
Overall Study 40 mg Cocaine with140 mg Phendimetrazine	10
Overall Study 80 mg Cocaine with140 mg Phendimetrazine	10
Overall Study 0 mg Cocaine With 210 mg Phendimetrazine	10
Overall Study 10 mg Cocaine with210 mg Phendimetrazine	10
Overall Study 20 mg Cocaine with210 mg Phendimetrazine	10
Overall Study 40 mg Cocaine with210 mg Phendimetrazine	10
Overall Study 80 mg Cocaine with210 mg Phendimetrazine	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

Phendimetrazine Dose Escalation Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Intranasal cocaine (10, 20, 40 and 80 mg) was administered acutely after at least seven days of maintenance on each condition. Intransasal placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo were determined during maintenance on placebo and phendimetrazine.

Overall Study Adverse Event

1

Baseline Characteristics

Phendimetrazine and Cocaine

Baseline characteristics by cohort

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Age, Continuous	43 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Systolic blood pressure was measured with an automated monitor. Higher values represent greater systolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Outcome measures

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Peak Systolic Pressure 0 mg Cocaine with 140 mg Phendimetrazine	117.9 mm Hg Standard Error 4.78
Peak Systolic Pressure 0 mg Cocaine with 0 mg Phendimetrazine	115.4 mm Hg Standard Error 2.54
Peak Systolic Pressure 10 mg Cocaine with 0 mg Phendimetrazine	121.3 mm Hg Standard Error 3.51
Peak Systolic Pressure 20 mg Cocaine with 0 mg Phendimetrazine	123.4 mm Hg Standard Error 4.06
Peak Systolic Pressure 40 mg Cocaine with 0 mg Phendimetrazine	122.1 mm Hg Standard Error 2.86
Peak Systolic Pressure 80 mg Cocaine with 0 mg Phendimetrazine	135.4 mm Hg Standard Error 3.89
Peak Systolic Pressure 0 mg Cocaine with 70 mg Phendimetrazine	120.0 mm Hg Standard Error 7.14
Peak Systolic Pressure 10 mg Cocaine with 70 mg Phendimetrazine	119.7 mm Hg Standard Error 3.54
Peak Systolic Pressure 20 mg Cocaine with 70 mg Phendimetrazine	119.9 mm Hg Standard Error 3.8
Peak Systolic Pressure 40 mg Cocaine with 70 mg Phendimetrazine	125.4 mm Hg Standard Error 6.05
Peak Systolic Pressure 80 mg Cocaine with 70 mg Phendimetrazine	130.3 mm Hg Standard Error 2.9
Peak Systolic Pressure 10 mg Cocaine with 140 mg Phendimetrazine	121.7 mm Hg Standard Error 4.73
Peak Systolic Pressure 20 mg Cocaine with 140 mg Phendimetrazine	122.1 mm Hg Standard Error 4.4
Peak Systolic Pressure 40 mg Cocaine with 140 mg Phendimetrazine	121.5 mm Hg Standard Error 4.51
Peak Systolic Pressure 80 mg Cocaine with 140 mg Phendimetrazine	131.9 mm Hg Standard Error 3.6
Peak Systolic Pressure 0 mg Cocaine with 210 mg Phendimetrazine	119.2 mm Hg Standard Error 3.45
Peak Systolic Pressure 10 mg Cocaine with 210 mg Phendimetrazine	119.7 mm Hg Standard Error 4.09
Peak Systolic Pressure 20 mg Cocaine with 210 mg Phendimetrazine	119.8 mm Hg Standard Error 2.65
Peak Systolic Pressure 40 mg Cocaine with 210 mg Phendimetrazine	119.3 mm Hg Standard Error 2.72
Peak Systolic Pressure 80 mg Cocaine with 210 mg Phendimetrazine	130.9 mm Hg Standard Error 2.95

PRIMARY outcome

Timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Diastolic blood pressure was measured with an automated monitor. Higher values represent greater diastolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Outcome measures

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Peak Diastolic Pressure 10 mg Cocaine with 210 mg Phendimetrazine	77.9 mm Hg Standard Error 1.99
Peak Diastolic Pressure 0 mg Cocaine with 0 mg Phendimetrazine	75.6 mm Hg Standard Error 1.28
Peak Diastolic Pressure 10 mg Cocaine with 0 mg Phendimetrazine	75.2 mm Hg Standard Error 1.63
Peak Diastolic Pressure 20 mg Cocaine with 0 mg Phendimetrazine	78.4 mm Hg Standard Error 1.88
Peak Diastolic Pressure 40 mg Cocaine with 0 mg Phendimetrazine	78 mm Hg Standard Error 1.38
Peak Diastolic Pressure 80 mg Cocaine with 0 mg Phendimetrazine	80.8 mm Hg Standard Error 1.87
Peak Diastolic Pressure 0 mg Cocaine with 70 mg Phendimetrazine	77.2 mm Hg Standard Error 2.7
Peak Diastolic Pressure 10 mg Cocaine with 70 mg Phendimetrazine	76.7 mm Hg Standard Error 2.62
Peak Diastolic Pressure 20 mg Cocaine with 70 mg Phendimetrazine	75.6 mm Hg Standard Error 2.45
Peak Diastolic Pressure 40 mg Cocaine with 70 mg Phendimetrazine	75.6 mm Hg Standard Error 3.02
Peak Diastolic Pressure 80 mg Cocaine with 70 mg Phendimetrazine	83.2 mm Hg Standard Error 2.69
Peak Diastolic Pressure 0 mg Cocaine with 140 mg Phendimetrazine	74.3 mm Hg Standard Error 1.72
Peak Diastolic Pressure 10 mg Cocaine with 140 mg Phendimetrazine	76 mm Hg Standard Error 1.84
Peak Diastolic Pressure 20 mg Cocaine with 140 mg Phendimetrazine	78.1 mm Hg Standard Error 1.29
Peak Diastolic Pressure 40 mg Cocaine with 140 mg Phendimetrazine	77.7 mm Hg Standard Error 2.28
Peak Diastolic Pressure 80 mg Cocaine with 140 mg Phendimetrazine	83.6 mm Hg Standard Error 1.26
Peak Diastolic Pressure 0 mg Cocaine with 210 mg Phendimetrazine	76.6 mm Hg Standard Error 2.42
Peak Diastolic Pressure 20 mg Cocaine with 210 mg Phendimetrazine	80.7 mm Hg Standard Error 2.34
Peak Diastolic Pressure 40 mg Cocaine with 210 mg Phendimetrazine	78.6 mm Hg Standard Error 1.83
Peak Diastolic Pressure 80 mg Cocaine with 210 mg Phendimetrazine	84.8 mm Hg Standard Error 2.37

PRIMARY outcome

Timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Heart rate was measured with an automated monitor. Higher values represent greater heart rate. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Outcome measures

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Peak Heart Rate 40 mg Cocaine with 210 mg Phendimetrazine	82.8 Beats per Minute Standard Error 3.08
Peak Heart Rate 0 mg Cocaine with 0 mg Phendimetrazine	75 Beats per Minute Standard Error 3.72
Peak Heart Rate 10 mg Cocaine with 0 mg Phendimetrazine	72.7 Beats per Minute Standard Error 2.64
Peak Heart Rate 20 mg Cocaine with 0 mg Phendimetrazine	77.4 Beats per Minute Standard Error 4.19
Peak Heart Rate 40 mg Cocaine with 0 mg Phendimetrazine	79.2 Beats per Minute Standard Error 4.63
Peak Heart Rate 80 mg Cocaine with 0 mg Phendimetrazine	87.8 Beats per Minute Standard Error 5.6
Peak Heart Rate 0 mg Cocaine with 70 mg Phendimetrazine	76.6 Beats per Minute Standard Error 2.57
Peak Heart Rate 10 mg Cocaine with 70 mg Phendimetrazine	75.3 Beats per Minute Standard Error 3.21
Peak Heart Rate 20 mg Cocaine with 70 mg Phendimetrazine	77 Beats per Minute Standard Error 3.06
Peak Heart Rate 40 mg Cocaine with 70 mg Phendimetrazine	81 Beats per Minute Standard Error 4.48
Peak Heart Rate 80 mg Cocaine with 70 mg Phendimetrazine	83.8 Beats per Minute Standard Error 3.92
Peak Heart Rate 0 mg Cocaine with 140 mg Phendimetrazine	82.1 Beats per Minute Standard Error 4.07
Peak Heart Rate 10 mg Cocaine with 140 mg Phendimetrazine	81.1 Beats per Minute Standard Error 3.87
Peak Heart Rate 20 mg Cocaine with 140 mg Phendimetrazine	83.4 Beats per Minute Standard Error 4.81
Peak Heart Rate 40 mg Cocaine with 140 mg Phendimetrazine	83.5 Beats per Minute Standard Error 3.66
Peak Heart Rate 80 mg Cocaine with 140 mg Phendimetrazine	84.8 Beats per Minute Standard Error 4.03
Peak Heart Rate 0 mg Cocaine with 210 mg Phendimetrazine	84.9 Beats per Minute Standard Error 2.28
Peak Heart Rate 10 mg Cocaine with 210 mg Phendimetrazine	77.5 Beats per Minute Standard Error 2.2
Peak Heart Rate 20 mg Cocaine with 210 mg Phendimetrazine	85.3 Beats per Minute Standard Error 4.05
Peak Heart Rate 80 mg Cocaine with 210 mg Phendimetrazine	88.9 Beats per Minute Standard Error 4.13

PRIMARY outcome

Timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Oral temperature was measured with an automated monitor. Higher values represent greater temperature. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Outcome measures

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Peak Temperature 0 mg Cocaine with 70 mg Phendimetrazine	98.25 Degrees Fahrenheit Standard Error .07
Peak Temperature 0 mg Cocaine with 140 mg Phendimetrazine	98.19 Degrees Fahrenheit Standard Error .04
Peak Temperature 10 mg Cocaine with 140 mg Phendimetrazine	98.17 Degrees Fahrenheit Standard Error .06
Peak Temperature 0 mg Cocaine with 0 mg Phendimetrazine	98.09 Degrees Fahrenheit Standard Error .13
Peak Temperature 10 mg Cocaine with 0 mg Phendimetrazine	98.12 Degrees Fahrenheit Standard Error .17
Peak Temperature 20 mg Cocaine with 0 mg Phendimetrazine	98.24 Degrees Fahrenheit Standard Error .12
Peak Temperature 40 mg Cocaine with 0 mg Phendimetrazine	98.21 Degrees Fahrenheit Standard Error .15
Peak Temperature 80 mg Cocaine with 0 mg Phendimetrazine	98.04 Degrees Fahrenheit Standard Error .29
Peak Temperature 10 mg Cocaine with 70 mg Phendimetrazine	98.28 Degrees Fahrenheit Standard Error .08
Peak Temperature 20 mg Cocaine with 70 mg Phendimetrazine	98.25 Degrees Fahrenheit Standard Error .12
Peak Temperature 40 mg Cocaine with 70 mg Phendimetrazine	98.24 Degrees Fahrenheit Standard Error .22
Peak Temperature 80 mg Cocaine with 70 mg Phendimetrazine	98.32 Degrees Fahrenheit Standard Error .17
Peak Temperature 20 mg Cocaine with 140 mg Phendimetrazine	98.25 Degrees Fahrenheit Standard Error .05
Peak Temperature 40 mg Cocaine with 140 mg Phendimetrazine	98.2 Degrees Fahrenheit Standard Error .09
Peak Temperature 80 mg Cocaine with 140 mg Phendimetrazine	98.3 Degrees Fahrenheit Standard Error .04
Peak Temperature 0 mg Cocaine with 210 mg Phendimetrazine	98.41 Degrees Fahrenheit Standard Error .07
Peak Temperature 10 mg Cocaine with 210 mg Phendimetrazine	98.17 Degrees Fahrenheit Standard Error .06
Peak Temperature 20 mg Cocaine with 210 mg Phendimetrazine	98.18 Degrees Fahrenheit Standard Error .08
Peak Temperature 40 mg Cocaine with 210 mg Phendimetrazine	98.24 Degrees Fahrenheit Standard Error .07
Peak Temperature 80 mg Cocaine with 210 mg Phendimetrazine	98.38 Degrees Fahrenheit Standard Error .1

SECONDARY outcome

Timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Subjects completed 16 items that loaded into the Sedative Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 "sedative" items was summed to yield the Sedative Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.

Outcome measures

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Peak Score on Sedative Subscale of the Adjective Rating Scale 10 mg Cocaine with 0 mg Phendimetrazine	2.5 units on a scale Standard Error .96
Peak Score on Sedative Subscale of the Adjective Rating Scale 80 mg Cocaine with 210 mg Phendimetrazine	4.7 units on a scale Standard Error 2.26
Peak Score on Sedative Subscale of the Adjective Rating Scale 0 mg Cocaine with 0 mg Phendimetrazine	2.3 units on a scale Standard Error .68
Peak Score on Sedative Subscale of the Adjective Rating Scale 20 mg Cocaine with 0 mg Phendimetrazine	2.5 units on a scale Standard Error .99
Peak Score on Sedative Subscale of the Adjective Rating Scale 40 mg Cocaine with 0 mg Phendimetrazine	2.4 units on a scale Standard Error .82
Peak Score on Sedative Subscale of the Adjective Rating Scale 80 mg Cocaine with 0 mg Phendimetrazine	4.4 units on a scale Standard Error 1.54
Peak Score on Sedative Subscale of the Adjective Rating Scale 0 mg Cocaine with 70 mg Phendimetrazine	1.9 units on a scale Standard Error .59
Peak Score on Sedative Subscale of the Adjective Rating Scale 10 mg Cocaine with 70 mg Phendimetrazine	2.2 units on a scale Standard Error 1.03
Peak Score on Sedative Subscale of the Adjective Rating Scale 20 mg Cocaine with 70 mg Phendimetrazine	3.5 units on a scale Standard Error 1.65
Peak Score on Sedative Subscale of the Adjective Rating Scale 40 mg Cocaine with 70 mg Phendimetrazine	4.2 units on a scale Standard Error 2.27
Peak Score on Sedative Subscale of the Adjective Rating Scale 80 mg Cocaine with 70 mg Phendimetrazine	4.2 units on a scale Standard Error 2.06
Peak Score on Sedative Subscale of the Adjective Rating Scale 0 mg Cocaine with 140 mg Phendimetrazine	2.1 units on a scale Standard Error 1.22
Peak Score on Sedative Subscale of the Adjective Rating Scale 10 mg Cocaine with 140 mg Phendimetrazine	2.7 units on a scale Standard Error 1.56
Peak Score on Sedative Subscale of the Adjective Rating Scale 20 mg Cocaine with 140 mg Phendimetrazine	3.1 units on a scale Standard Error 1.62
Peak Score on Sedative Subscale of the Adjective Rating Scale 40 mg Cocaine with 140 mg Phendimetrazine	2.8 units on a scale Standard Error 1.52
Peak Score on Sedative Subscale of the Adjective Rating Scale 80 mg Cocaine with 140 mg Phendimetrazine	4.0 units on a scale Standard Error 2.19
Peak Score on Sedative Subscale of the Adjective Rating Scale 0 mg Cocaine with 210 mg Phendimetrazine	1.8 units on a scale Standard Error .57
Peak Score on Sedative Subscale of the Adjective Rating Scale 10 mg Cocaine with 210 mg Phendimetrazine	2.6 units on a scale Standard Error .9
Peak Score on Sedative Subscale of the Adjective Rating Scale 20 mg Cocaine with 210 mg Phendimetrazine	3.8 units on a scale Standard Error 1.4
Peak Score on Sedative Subscale of the Adjective Rating Scale 40 mg Cocaine with 210 mg Phendimetrazine	4.2 units on a scale Standard Error 1.68

SECONDARY outcome

Timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Subjects completed 16 items that loaded into the Stimulant Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 "stimulant" items was summed to yield the Stimulant Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.

Outcome measures

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Peak Score on Stimulant Subscale of the Adjective Rating Scale 20 mg Cocaine with 0 mg Phendimetrazine	6.3 units on a scale Standard Error 1.52
Peak Score on Stimulant Subscale of the Adjective Rating Scale 0 mg Cocaine with 0 mg Phendimetrazine	5.2 units on a scale Standard Error 1.05
Peak Score on Stimulant Subscale of the Adjective Rating Scale 10 mg Cocaine with 0 mg Phendimetrazine	5.5 units on a scale Standard Error 1.33
Peak Score on Stimulant Subscale of the Adjective Rating Scale 40 mg Cocaine with 0 mg Phendimetrazine	6.6 units on a scale Standard Error 1.64
Peak Score on Stimulant Subscale of the Adjective Rating Scale 80 mg Cocaine with 0 mg Phendimetrazine	8.1 units on a scale Standard Error 1.47
Peak Score on Stimulant Subscale of the Adjective Rating Scale 0 mg Cocaine with 70 mg Phendimetrazine	4.4 units on a scale Standard Error .97
Peak Score on Stimulant Subscale of the Adjective Rating Scale 10 mg Cocaine with 70 mg Phendimetrazine	5.2 units on a scale Standard Error .92
Peak Score on Stimulant Subscale of the Adjective Rating Scale 20 mg Cocaine with 70 mg Phendimetrazine	6.3 units on a scale Standard Error 1.17
Peak Score on Stimulant Subscale of the Adjective Rating Scale 40 mg Cocaine with 70 mg Phendimetrazine	6.2 units on a scale Standard Error .9
Peak Score on Stimulant Subscale of the Adjective Rating Scale 80 mg Cocaine with 70 mg Phendimetrazine	7.3 units on a scale Standard Error 1.26
Peak Score on Stimulant Subscale of the Adjective Rating Scale 0 mg Cocaine with 140 mg Phendimetrazine	3.7 units on a scale Standard Error 1.10
Peak Score on Stimulant Subscale of the Adjective Rating Scale 10 mg Cocaine with 140 mg Phendimetrazine	5.3 units on a scale Standard Error .91
Peak Score on Stimulant Subscale of the Adjective Rating Scale 20 mg Cocaine with 140 mg Phendimetrazine	5.8 units on a scale Standard Error 1.18
Peak Score on Stimulant Subscale of the Adjective Rating Scale 40 mg Cocaine with 140 mg Phendimetrazine	7.8 units on a scale Standard Error 1.54
Peak Score on Stimulant Subscale of the Adjective Rating Scale 80 mg Cocaine with 140 mg Phendimetrazine	8.1 units on a scale Standard Error 1.43
Peak Score on Stimulant Subscale of the Adjective Rating Scale 0 mg Cocaine with 210 mg Phendimetrazine	4.7 units on a scale Standard Error 1.08
Peak Score on Stimulant Subscale of the Adjective Rating Scale 10 mg Cocaine with 210 mg Phendimetrazine	5.2 units on a scale Standard Error 1.14
Peak Score on Stimulant Subscale of the Adjective Rating Scale 20 mg Cocaine with 210 mg Phendimetrazine	7.4 units on a scale Standard Error 1.38
Peak Score on Stimulant Subscale of the Adjective Rating Scale 40 mg Cocaine with 210 mg Phendimetrazine	7.3 units on a scale Standard Error 1.35
Peak Score on Stimulant Subscale of the Adjective Rating Scale 80 mg Cocaine with 210 mg Phendimetrazine	9 units on a scale Standard Error 1.23

SECONDARY outcome

Timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Subjects rated their feelings of "Active, Alert, Energetic" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.

Outcome measures

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale 0 mg Cocaine with 0 mg Phendimetrazine	.6 units on a scale Standard Error .5
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale 10 mg Cocaine with 0 mg Phendimetrazine	3.9 units on a scale Standard Error 1.91
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale 20 mg Cocaine with 0 mg Phendimetrazine	8.9 units on a scale Standard Error 3.89
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale 40 mg Cocaine with 0 mg Phendimetrazine	7.8 units on a scale Standard Error 4.99
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale 80 mg Cocaine with 0 mg Phendimetrazine	14 units on a scale Standard Error 6.23
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale 0 mg Cocaine with 70 mg Phendimetrazine	1.5 units on a scale Standard Error 1
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale 10 mg Cocaine with 70 mg Phendimetrazine	6 units on a scale Standard Error 2.28
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale 20 mg Cocaine with 70 mg Phendimetrazine	9 units on a scale Standard Error 3.87
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale 40 mg Cocaine with 70 mg Phendimetrazine	13.4 units on a scale Standard Error 3.91
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale 80 mg Cocaine with 70 mg Phendimetrazine	16 units on a scale Standard Error 4.17
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale 0 mg Cocaine with 140 mg Phendimetrazine	.7 units on a scale Standard Error .6
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale 10 mg Cocaine with 140 mg Phendimetrazine	4 units on a scale Standard Error 1.76
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale 20 mg Cocaine with 140 mg Phendimetrazine	11.4 units on a scale Standard Error 4.7
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale 40 mg Cocaine with 140 mg Phendimetrazine	14.8 units on a scale Standard Error 4.7
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale 80 mg Cocaine with 140 mg Phendimetrazine	18.9 units on a scale Standard Error 5.31
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale 0 mg Cocaine with 210 mg Phendimetrazine	1 units on a scale Standard Error .89
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale 10 mg Cocaine with 210 mg Phendimetrazine	1.8 units on a scale Standard Error .85
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale 20 mg Cocaine with 210 mg Phendimetrazine	10.1 units on a scale Standard Error 3.71
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale 40 mg Cocaine with 210 mg Phendimetrazine	11.1 units on a scale Standard Error 3.89
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale 80 mg Cocaine with 210 mg Phendimetrazine	17 units on a scale Standard Error 5.8

SECONDARY outcome

Timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Subjects rated their feelings of "Any Effect" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.

Outcome measures

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Peak Ratings of "Any Effect" on the Visual Analog Scale 20 mg Cocaine with 140 mg Phendimetrazine	12.8 units on a scale Standard Error 3.59
Peak Ratings of "Any Effect" on the Visual Analog Scale 80 mg Cocaine with 140 mg Phendimetrazine	28.1 units on a scale Standard Error 4.86
Peak Ratings of "Any Effect" on the Visual Analog Scale 0 mg Cocaine with 210 mg Phendimetrazine	4.6 units on a scale Standard Error 2.74
Peak Ratings of "Any Effect" on the Visual Analog Scale 80 mg Cocaine with 70 mg Phendimetrazine	27.3 units on a scale Standard Error 7.81
Peak Ratings of "Any Effect" on the Visual Analog Scale 0 mg Cocaine with 140 mg Phendimetrazine	.5 units on a scale Standard Error .5
Peak Ratings of "Any Effect" on the Visual Analog Scale 10 mg Cocaine with 140 mg Phendimetrazine	7 units on a scale Standard Error 1.99
Peak Ratings of "Any Effect" on the Visual Analog Scale 40 mg Cocaine with 140 mg Phendimetrazine	19 units on a scale Standard Error 4.96
Peak Ratings of "Any Effect" on the Visual Analog Scale 10 mg Cocaine with 210 mg Phendimetrazine	10.5 units on a scale Standard Error 3.37
Peak Ratings of "Any Effect" on the Visual Analog Scale 20 mg Cocaine with 210 mg Phendimetrazine	14.7 units on a scale Standard Error 4.33
Peak Ratings of "Any Effect" on the Visual Analog Scale 0 mg Cocaine with 0 mg Phendimetrazine	1.5 units on a scale Standard Error .83
Peak Ratings of "Any Effect" on the Visual Analog Scale 10 mg Cocaine with 0 mg Phendimetrazine	4.7 units on a scale Standard Error 1.57
Peak Ratings of "Any Effect" on the Visual Analog Scale 20 mg Cocaine with 0 mg Phendimetrazine	13.2 units on a scale Standard Error 4.93
Peak Ratings of "Any Effect" on the Visual Analog Scale 40 mg Cocaine with 0 mg Phendimetrazine	16.9 units on a scale Standard Error 4.32
Peak Ratings of "Any Effect" on the Visual Analog Scale 80 mg Cocaine with 0 mg Phendimetrazine	26 units on a scale Standard Error 6.53
Peak Ratings of "Any Effect" on the Visual Analog Scale 0 mg Cocaine with 70 mg Phendimetrazine	.9 units on a scale Standard Error .64
Peak Ratings of "Any Effect" on the Visual Analog Scale 10 mg Cocaine with 70 mg Phendimetrazine	7.7 units on a scale Standard Error 2.59
Peak Ratings of "Any Effect" on the Visual Analog Scale 20 mg Cocaine with 70 mg Phendimetrazine	13.5 units on a scale Standard Error 4.84
Peak Ratings of "Any Effect" on the Visual Analog Scale 40 mg Cocaine with 70 mg Phendimetrazine	21.2 units on a scale Standard Error 6.9
Peak Ratings of "Any Effect" on the Visual Analog Scale 40 mg Cocaine with 210 mg Phendimetrazine	21.5 units on a scale Standard Error 4.25
Peak Ratings of "Any Effect" on the Visual Analog Scale 80 mg Cocaine with 210 mg Phendimetrazine	35.1 units on a scale Standard Error 7.54

SECONDARY outcome

Timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Subjects rated their feelings of "Bad Effect" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.

Outcome measures

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Peak Ratings of "Bad Effect" on the Visual Analog Scale 80 mg Cocaine with 140 mg Phendimetrazine	11.4 units on a scale Standard Error 5.39
Peak Ratings of "Bad Effect" on the Visual Analog Scale 0 mg Cocaine with 0 mg Phendimetrazine	.6 units on a scale Standard Error .4
Peak Ratings of "Bad Effect" on the Visual Analog Scale 10 mg Cocaine with 0 mg Phendimetrazine	2.1 units on a scale Standard Error 1.3
Peak Ratings of "Bad Effect" on the Visual Analog Scale 20 mg Cocaine with 0 mg Phendimetrazine	4.9 units on a scale Standard Error 3.52
Peak Ratings of "Bad Effect" on the Visual Analog Scale 40 mg Cocaine with 0 mg Phendimetrazine	6.6 units on a scale Standard Error 4.04
Peak Ratings of "Bad Effect" on the Visual Analog Scale 80 mg Cocaine with 0 mg Phendimetrazine	8.5 units on a scale Standard Error 4.74
Peak Ratings of "Bad Effect" on the Visual Analog Scale 0 mg Cocaine with 70 mg Phendimetrazine	1.3 units on a scale Standard Error .87
Peak Ratings of "Bad Effect" on the Visual Analog Scale 10 mg Cocaine with 70 mg Phendimetrazine	2 units on a scale Standard Error 1.42
Peak Ratings of "Bad Effect" on the Visual Analog Scale 20 mg Cocaine with 70 mg Phendimetrazine	5.6 units on a scale Standard Error 2.4
Peak Ratings of "Bad Effect" on the Visual Analog Scale 40 mg Cocaine with 70 mg Phendimetrazine	4.9 units on a scale Standard Error 2.70
Peak Ratings of "Bad Effect" on the Visual Analog Scale 80 mg Cocaine with 70 mg Phendimetrazine	5.6 units on a scale Standard Error 3.73
Peak Ratings of "Bad Effect" on the Visual Analog Scale 0 mg Cocaine with 140 mg Phendimetrazine	.7 units on a scale Standard Error .7
Peak Ratings of "Bad Effect" on the Visual Analog Scale 10 mg Cocaine with 140 mg Phendimetrazine	1.9 units on a scale Standard Error 1.33
Peak Ratings of "Bad Effect" on the Visual Analog Scale 20 mg Cocaine with 140 mg Phendimetrazine	5.7 units on a scale Standard Error 3.14
Peak Ratings of "Bad Effect" on the Visual Analog Scale 40 mg Cocaine with 140 mg Phendimetrazine	3.7 units on a scale Standard Error 2.63
Peak Ratings of "Bad Effect" on the Visual Analog Scale 0 mg Cocaine with 210 mg Phendimetrazine	9.2 units on a scale Standard Error 7.77
Peak Ratings of "Bad Effect" on the Visual Analog Scale 10 mg Cocaine with 210 mg Phendimetrazine	2.4 units on a scale Standard Error 1.52
Peak Ratings of "Bad Effect" on the Visual Analog Scale 20 mg Cocaine with 210 mg Phendimetrazine	3.9 units on a scale Standard Error 2.17
Peak Ratings of "Bad Effect" on the Visual Analog Scale 40 mg Cocaine with 210 mg Phendimetrazine	8.1 units on a scale Standard Error 4.45
Peak Ratings of "Bad Effect" on the Visual Analog Scale 80 mg Cocaine with 210 mg Phendimetrazine	10.2 units on a scale Standard Error 7.23

SECONDARY outcome

Timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Subjects rated their feelings of "Euphoric" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.

Outcome measures

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Peak Ratings of "Euphoric" on the Visual Analog Scale 0 mg Cocaine with 0 mg Phendimetrazine	1 units on a scale Standard Error .89
Peak Ratings of "Euphoric" on the Visual Analog Scale 10 mg Cocaine with 0 mg Phendimetrazine	1.8 units on a scale Standard Error .87
Peak Ratings of "Euphoric" on the Visual Analog Scale 20 mg Cocaine with 0 mg Phendimetrazine	3.1 units on a scale Standard Error 1.87
Peak Ratings of "Euphoric" on the Visual Analog Scale 40 mg Cocaine with 0 mg Phendimetrazine	1.2 units on a scale Standard Error .81
Peak Ratings of "Euphoric" on the Visual Analog Scale 80 mg Cocaine with 0 mg Phendimetrazine	1.9 units on a scale Standard Error 1.32
Peak Ratings of "Euphoric" on the Visual Analog Scale 0 mg Cocaine with 70 mg Phendimetrazine	1 units on a scale Standard Error .6
Peak Ratings of "Euphoric" on the Visual Analog Scale 10 mg Cocaine with 70 mg Phendimetrazine	1 units on a scale Standard Error .52
Peak Ratings of "Euphoric" on the Visual Analog Scale 20 mg Cocaine with 70 mg Phendimetrazine	3.2 units on a scale Standard Error 1.52
Peak Ratings of "Euphoric" on the Visual Analog Scale 40 mg Cocaine with 70 mg Phendimetrazine	1.2 units on a scale Standard Error .63
Peak Ratings of "Euphoric" on the Visual Analog Scale 80 mg Cocaine with 70 mg Phendimetrazine	2 units on a scale Standard Error 1
Peak Ratings of "Euphoric" on the Visual Analog Scale 0 mg Cocaine with 140 mg Phendimetrazine	.9 units on a scale Standard Error .64
Peak Ratings of "Euphoric" on the Visual Analog Scale 10 mg Cocaine with 140 mg Phendimetrazine	2 units on a scale Standard Error 1.16
Peak Ratings of "Euphoric" on the Visual Analog Scale 20 mg Cocaine with 140 mg Phendimetrazine	1.3 units on a scale Standard Error .7
Peak Ratings of "Euphoric" on the Visual Analog Scale 40 mg Cocaine with 140 mg Phendimetrazine	1 units on a scale Standard Error .54
Peak Ratings of "Euphoric" on the Visual Analog Scale 80 mg Cocaine with 140 mg Phendimetrazine	1.3 units on a scale Standard Error .7
Peak Ratings of "Euphoric" on the Visual Analog Scale 0 mg Cocaine with 210 mg Phendimetrazine	.9 units on a scale Standard Error .48
Peak Ratings of "Euphoric" on the Visual Analog Scale 10 mg Cocaine with 210 mg Phendimetrazine	.4 units on a scale Standard Error .4
Peak Ratings of "Euphoric" on the Visual Analog Scale 20 mg Cocaine with 210 mg Phendimetrazine	1 units on a scale Standard Error .68
Peak Ratings of "Euphoric" on the Visual Analog Scale 40 mg Cocaine with 210 mg Phendimetrazine	.8 units on a scale Standard Error .47
Peak Ratings of "Euphoric" on the Visual Analog Scale 80 mg Cocaine with 210 mg Phendimetrazine	1.7 units on a scale Standard Error .82

SECONDARY outcome

Timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Subjects rated their feelings of "Good Effect" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.

Outcome measures

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Peak Ratings of "Good Effect" on the Visual Analog Scale 0 mg Cocaine with 0 mg Phendimetrazine	1.2 units on a scale Standard Error .73
Peak Ratings of "Good Effect" on the Visual Analog Scale 10 mg Cocaine with 0 mg Phendimetrazine	7.1 units on a scale Standard Error 2.74
Peak Ratings of "Good Effect" on the Visual Analog Scale 20 mg Cocaine with 0 mg Phendimetrazine	12.4 units on a scale Standard Error 4.61
Peak Ratings of "Good Effect" on the Visual Analog Scale 40 mg Cocaine with 0 mg Phendimetrazine	12.3 units on a scale Standard Error 5.27
Peak Ratings of "Good Effect" on the Visual Analog Scale 80 mg Cocaine with 0 mg Phendimetrazine	19.8 units on a scale Standard Error 7.01
Peak Ratings of "Good Effect" on the Visual Analog Scale 0 mg Cocaine with 70 mg Phendimetrazine	1.3 units on a scale Standard Error .94
Peak Ratings of "Good Effect" on the Visual Analog Scale 10 mg Cocaine with 70 mg Phendimetrazine	7.1 units on a scale Standard Error 2.48
Peak Ratings of "Good Effect" on the Visual Analog Scale 20 mg Cocaine with 70 mg Phendimetrazine	11.7 units on a scale Standard Error 3.77
Peak Ratings of "Good Effect" on the Visual Analog Scale 40 mg Cocaine with 70 mg Phendimetrazine	15.3 units on a scale Standard Error 5.14
Peak Ratings of "Good Effect" on the Visual Analog Scale 80 mg Cocaine with 70 mg Phendimetrazine	21.3 units on a scale Standard Error 5.57
Peak Ratings of "Good Effect" on the Visual Analog Scale 0 mg Cocaine with 140 mg Phendimetrazine	2.1 units on a scale Standard Error 1.13
Peak Ratings of "Good Effect" on the Visual Analog Scale 10 mg Cocaine with 140 mg Phendimetrazine	8.1 units on a scale Standard Error 2.67
Peak Ratings of "Good Effect" on the Visual Analog Scale 20 mg Cocaine with 140 mg Phendimetrazine	7.9 units on a scale Standard Error 3.9
Peak Ratings of "Good Effect" on the Visual Analog Scale 40 mg Cocaine with 140 mg Phendimetrazine	15.4 units on a scale Standard Error 5.39
Peak Ratings of "Good Effect" on the Visual Analog Scale 80 mg Cocaine with 140 mg Phendimetrazine	27.8 units on a scale Standard Error 6.5
Peak Ratings of "Good Effect" on the Visual Analog Scale 0 mg Cocaine with 210 mg Phendimetrazine	9.2 units on a scale Standard Error 7.77
Peak Ratings of "Good Effect" on the Visual Analog Scale 10 mg Cocaine with 210 mg Phendimetrazine	12 units on a scale Standard Error 4.51
Peak Ratings of "Good Effect" on the Visual Analog Scale 20 mg Cocaine with 210 mg Phendimetrazine	16.7 units on a scale Standard Error 6.33
Peak Ratings of "Good Effect" on the Visual Analog Scale 40 mg Cocaine with 210 mg Phendimetrazine	17.1 units on a scale Standard Error 4.33
Peak Ratings of "Good Effect" on the Visual Analog Scale 80 mg Cocaine with 210 mg Phendimetrazine	27.2 units on a scale Standard Error 7.56

SECONDARY outcome

Timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Subjects rated their feelings of "High" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.

Outcome measures

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Peak Ratings of "High" on the Visual Analog Scale 80 mg Cocaine with 0 mg Phendimetrazine	23.4 units on a scale Standard Error 6.42
Peak Ratings of "High" on the Visual Analog Scale 10 mg Cocaine with 140 mg Phendimetrazine	6.3 units on a scale Standard Error 2.96
Peak Ratings of "High" on the Visual Analog Scale 0 mg Cocaine with 0 mg Phendimetrazine	1.4 units on a scale Standard Error .69
Peak Ratings of "High" on the Visual Analog Scale 10 mg Cocaine with 0 mg Phendimetrazine	6 units on a scale Standard Error 2.29
Peak Ratings of "High" on the Visual Analog Scale 20 mg Cocaine with 0 mg Phendimetrazine	14.1 units on a scale Standard Error 4.9
Peak Ratings of "High" on the Visual Analog Scale 40 mg Cocaine with 0 mg Phendimetrazine	11.9 units on a scale Standard Error 4.81
Peak Ratings of "High" on the Visual Analog Scale 0 mg Cocaine with 70 mg Phendimetrazine	1.1 units on a scale Standard Error .6
Peak Ratings of "High" on the Visual Analog Scale 10 mg Cocaine with 70 mg Phendimetrazine	3.6 units on a scale Standard Error 1.18
Peak Ratings of "High" on the Visual Analog Scale 20 mg Cocaine with 70 mg Phendimetrazine	10.8 units on a scale Standard Error 4.14
Peak Ratings of "High" on the Visual Analog Scale 40 mg Cocaine with 70 mg Phendimetrazine	13.3 units on a scale Standard Error 5.55
Peak Ratings of "High" on the Visual Analog Scale 80 mg Cocaine with 70 mg Phendimetrazine	18.6 units on a scale Standard Error 6.52
Peak Ratings of "High" on the Visual Analog Scale 0 mg Cocaine with 140 mg Phendimetrazine	.6 units on a scale Standard Error .5
Peak Ratings of "High" on the Visual Analog Scale 20 mg Cocaine with 140 mg Phendimetrazine	9.1 units on a scale Standard Error 4.39
Peak Ratings of "High" on the Visual Analog Scale 40 mg Cocaine with 140 mg Phendimetrazine	15.8 units on a scale Standard Error 5.96
Peak Ratings of "High" on the Visual Analog Scale 80 mg Cocaine with 140 mg Phendimetrazine	24.2 units on a scale Standard Error 6.77
Peak Ratings of "High" on the Visual Analog Scale 0 mg Cocaine with 210 mg Phendimetrazine	.8 units on a scale Standard Error .59
Peak Ratings of "High" on the Visual Analog Scale 10 mg Cocaine with 210 mg Phendimetrazine	8.3 units on a scale Standard Error 4.14
Peak Ratings of "High" on the Visual Analog Scale 20 mg Cocaine with 210 mg Phendimetrazine	15.3 units on a scale Standard Error 6.35
Peak Ratings of "High" on the Visual Analog Scale 40 mg Cocaine with 210 mg Phendimetrazine	12.1 units on a scale Standard Error 3.14
Peak Ratings of "High" on the Visual Analog Scale 80 mg Cocaine with 210 mg Phendimetrazine	22.6 units on a scale Standard Error 7.05

SECONDARY outcome

Timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Subjects rated their feelings of "Irregular/Racing Heartbeat" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.

Outcome measures

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale 20 mg Cocaine with 70 mg Phendimetrazine	6.9 units on a scale Standard Error 3.7
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale 0 mg Cocaine with 210 mg Phendimetrazine	2.3 units on a scale Standard Error 1.21
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale 0 mg Cocaine with 0 mg Phendimetrazine	.8 units on a scale Standard Error .51
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale 10 mg Cocaine with 0 mg Phendimetrazine	2.8 units on a scale Standard Error 1.19
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale 20 mg Cocaine with 0 mg Phendimetrazine	10.8 units on a scale Standard Error 4.07
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale 40 mg Cocaine with 0 mg Phendimetrazine	9.2 units on a scale Standard Error 5
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale 80 mg Cocaine with 0 mg Phendimetrazine	14.6 units on a scale Standard Error 7
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale 0 mg Cocaine with 70 mg Phendimetrazine	.4 units on a scale Standard Error .4
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale 10 mg Cocaine with 70 mg Phendimetrazine	1.6 units on a scale Standard Error .6
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale 40 mg Cocaine with 70 mg Phendimetrazine	2.4 units on a scale Standard Error 1.3
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale 80 mg Cocaine with 70 mg Phendimetrazine	6 units on a scale Standard Error 2.9
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale 0 mg Cocaine with 140 mg Phendimetrazine	.6 units on a scale Standard Error .4
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale 10 mg Cocaine with 140 mg Phendimetrazine	.8 units on a scale Standard Error .55
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale 20 mg Cocaine with 140 mg Phendimetrazine	3.6 units on a scale Standard Error 2.56
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale 40 mg Cocaine with 140 mg Phendimetrazine	5.10 units on a scale Standard Error 2.15
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale 80 mg Cocaine with 140 mg Phendimetrazine	8.2 units on a scale Standard Error 4.17
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale 10 mg Cocaine with 210 mg Phendimetrazine	.6 units on a scale Standard Error .5
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale 20 mg Cocaine with 210 mg Phendimetrazine	4 units on a scale Standard Error 3.36
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale 40 mg Cocaine with 210 mg Phendimetrazine	5.5 units on a scale Standard Error 3.48
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale 80 mg Cocaine with 210 mg Phendimetrazine	9.8 units on a scale Standard Error 4.85

SECONDARY outcome

Timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Subjects rated their feelings of "Like Drug" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.

Outcome measures

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Peak Ratings of "Like Drug" on the Visual Analog Scale 0 mg Cocaine with 0 mg Phendimetrazine	1 units on a scale Standard Error .54
Peak Ratings of "Like Drug" on the Visual Analog Scale 10 mg Cocaine with 0 mg Phendimetrazine	6.4 units on a scale Standard Error 2.01
Peak Ratings of "Like Drug" on the Visual Analog Scale 20 mg Cocaine with 0 mg Phendimetrazine	12.9 units on a scale Standard Error 4.58
Peak Ratings of "Like Drug" on the Visual Analog Scale 40 mg Cocaine with 0 mg Phendimetrazine	14 units on a scale Standard Error 5.82
Peak Ratings of "Like Drug" on the Visual Analog Scale 80 mg Cocaine with 0 mg Phendimetrazine	23.2 units on a scale Standard Error 8.32
Peak Ratings of "Like Drug" on the Visual Analog Scale 0 mg Cocaine with 70 mg Phendimetrazine	.5 units on a scale Standard Error .5
Peak Ratings of "Like Drug" on the Visual Analog Scale 10 mg Cocaine with 70 mg Phendimetrazine	4.1 units on a scale Standard Error 1.49
Peak Ratings of "Like Drug" on the Visual Analog Scale 20 mg Cocaine with 70 mg Phendimetrazine	10.7 units on a scale Standard Error 3.52
Peak Ratings of "Like Drug" on the Visual Analog Scale 40 mg Cocaine with 70 mg Phendimetrazine	17.9 units on a scale Standard Error 5.13
Peak Ratings of "Like Drug" on the Visual Analog Scale 80 mg Cocaine with 70 mg Phendimetrazine	25 units on a scale Standard Error 6.93
Peak Ratings of "Like Drug" on the Visual Analog Scale 0 mg Cocaine with 140 mg Phendimetrazine	1.2 units on a scale Standard Error .8
Peak Ratings of "Like Drug" on the Visual Analog Scale 10 mg Cocaine with 140 mg Phendimetrazine	9.8 units on a scale Standard Error 3.16
Peak Ratings of "Like Drug" on the Visual Analog Scale 20 mg Cocaine with 140 mg Phendimetrazine	9.9 units on a scale Standard Error 3.93
Peak Ratings of "Like Drug" on the Visual Analog Scale 40 mg Cocaine with 140 mg Phendimetrazine	18 units on a scale Standard Error 6.01
Peak Ratings of "Like Drug" on the Visual Analog Scale 80 mg Cocaine with 140 mg Phendimetrazine	26.2 units on a scale Standard Error 6.32
Peak Ratings of "Like Drug" on the Visual Analog Scale 0 mg Cocaine with 210 mg Phendimetrazine	2.2 units on a scale Standard Error 1.44
Peak Ratings of "Like Drug" on the Visual Analog Scale 10 mg Cocaine with 210 mg Phendimetrazine	7.5 units on a scale Standard Error 2.66
Peak Ratings of "Like Drug" on the Visual Analog Scale 20 mg Cocaine with 210 mg Phendimetrazine	13.1 units on a scale Standard Error 4.72
Peak Ratings of "Like Drug" on the Visual Analog Scale 40 mg Cocaine with 210 mg Phendimetrazine	25.5 units on a scale Standard Error 9.3
Peak Ratings of "Like Drug" on the Visual Analog Scale 80 mg Cocaine with 210 mg Phendimetrazine	26.5 units on a scale Standard Error 8.32

SECONDARY outcome

Timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Subjects rated their feelings of "Nauseated/Queasy/Sick to Stomach" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.

Outcome measures

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Peak Ratings of "Nauseated/Queasy/Sick to Stomach" on the Visual Analog Scale 10 mg Cocaine with 210 mg Phendimetrazine	1.7 units on a scale Standard Error 1.25
Peak Ratings of "Nauseated/Queasy/Sick to Stomach" on the Visual Analog Scale 20 mg Cocaine with 210 mg Phendimetrazine	4.8 units on a scale Standard Error 2.83
Peak Ratings of "Nauseated/Queasy/Sick to Stomach" on the Visual Analog Scale 0 mg Cocaine with 0 mg Phendimetrazine	1.4 units on a scale Standard Error .69
Peak Ratings of "Nauseated/Queasy/Sick to Stomach" on the Visual Analog Scale 10 mg Cocaine with 0 mg Phendimetrazine	3.3 units on a scale Standard Error 1.54
Peak Ratings of "Nauseated/Queasy/Sick to Stomach" on the Visual Analog Scale 20 mg Cocaine with 0 mg Phendimetrazine	3.1 units on a scale Standard Error 1.29
Peak Ratings of "Nauseated/Queasy/Sick to Stomach" on the Visual Analog Scale 40 mg Cocaine with 0 mg Phendimetrazine	7.8 units on a scale Standard Error 2.59
Peak Ratings of "Nauseated/Queasy/Sick to Stomach" on the Visual Analog Scale 80 mg Cocaine with 0 mg Phendimetrazine	14 units on a scale Standard Error 5.79
Peak Ratings of "Nauseated/Queasy/Sick to Stomach" on the Visual Analog Scale 0 mg Cocaine with 70 mg Phendimetrazine	.6 units on a scale Standard Error .43
Peak Ratings of "Nauseated/Queasy/Sick to Stomach" on the Visual Analog Scale 10 mg Cocaine with 70 mg Phendimetrazine	4.3 units on a scale Standard Error 2.32
Peak Ratings of "Nauseated/Queasy/Sick to Stomach" on the Visual Analog Scale 20 mg Cocaine with 70 mg Phendimetrazine	4.3 units on a scale Standard Error 2.17
Peak Ratings of "Nauseated/Queasy/Sick to Stomach" on the Visual Analog Scale 40 mg Cocaine with 70 mg Phendimetrazine	5.3 units on a scale Standard Error 4.22
Peak Ratings of "Nauseated/Queasy/Sick to Stomach" on the Visual Analog Scale 80 mg Cocaine with 70 mg Phendimetrazine	10.5 units on a scale Standard Error 5.45
Peak Ratings of "Nauseated/Queasy/Sick to Stomach" on the Visual Analog Scale 0 mg Cocaine with 140 mg Phendimetrazine	.6 units on a scale Standard Error .5
Peak Ratings of "Nauseated/Queasy/Sick to Stomach" on the Visual Analog Scale 10 mg Cocaine with 140 mg Phendimetrazine	4.1 units on a scale Standard Error 2.77
Peak Ratings of "Nauseated/Queasy/Sick to Stomach" on the Visual Analog Scale 20 mg Cocaine with 140 mg Phendimetrazine	2.9 units on a scale Standard Error 1.96
Peak Ratings of "Nauseated/Queasy/Sick to Stomach" on the Visual Analog Scale 40 mg Cocaine with 140 mg Phendimetrazine	6.9 units on a scale Standard Error 3.59
Peak Ratings of "Nauseated/Queasy/Sick to Stomach" on the Visual Analog Scale 80 mg Cocaine with 140 mg Phendimetrazine	10.7 units on a scale Standard Error 5.7
Peak Ratings of "Nauseated/Queasy/Sick to Stomach" on the Visual Analog Scale 0 mg Cocaine with 210 mg Phendimetrazine	5.2 units on a scale Standard Error 4.14
Peak Ratings of "Nauseated/Queasy/Sick to Stomach" on the Visual Analog Scale 40 mg Cocaine with 210 mg Phendimetrazine	4.3 units on a scale Standard Error 2.54
Peak Ratings of "Nauseated/Queasy/Sick to Stomach" on the Visual Analog Scale 80 mg Cocaine with 210 mg Phendimetrazine	2.9 units on a scale Standard Error 1.89

SECONDARY outcome

Timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Subjects rated their feelings of "Nervous/Anxious" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.

Outcome measures

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale 80 mg Cocaine with 0 mg Phendimetrazine	9.4 units on a scale Standard Error 6
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale 0 mg Cocaine with 0 mg Phendimetrazine	.7 units on a scale Standard Error .47
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale 10 mg Cocaine with 0 mg Phendimetrazine	2.3 units on a scale Standard Error 1.12
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale 20 mg Cocaine with 0 mg Phendimetrazine	3.7 units on a scale Standard Error 2.27
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale 40 mg Cocaine with 0 mg Phendimetrazine	4.1 units on a scale Standard Error 2.61
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale 0 mg Cocaine with 70 mg Phendimetrazine	.6 units on a scale Standard Error .43
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale 10 mg Cocaine with 70 mg Phendimetrazine	.9 units on a scale Standard Error .53
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale 20 mg Cocaine with 70 mg Phendimetrazine	2 units on a scale Standard Error 1.14
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale 40 mg Cocaine with 70 mg Phendimetrazine	5.4 units on a scale Standard Error 2.50
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale 80 mg Cocaine with 70 mg Phendimetrazine	7.7 units on a scale Standard Error 4.46
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale 0 mg Cocaine with 140 mg Phendimetrazine	.5 units on a scale Standard Error .4
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale 10 mg Cocaine with 140 mg Phendimetrazine	1.7 units on a scale Standard Error .75
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale 20 mg Cocaine with 140 mg Phendimetrazine	2.5 units on a scale Standard Error 1.24
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale 40 mg Cocaine with 140 mg Phendimetrazine	6.7 units on a scale Standard Error 2.96
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale 80 mg Cocaine with 140 mg Phendimetrazine	10.5 units on a scale Standard Error 4.22
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale 0 mg Cocaine with 210 mg Phendimetrazine	.8 units on a scale Standard Error .55
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale 10 mg Cocaine with 210 mg Phendimetrazine	.5 units on a scale Standard Error .4
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale 20 mg Cocaine with 210 mg Phendimetrazine	3.7 units on a scale Standard Error 2.13
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale 40 mg Cocaine with 210 mg Phendimetrazine	4.4 units on a scale Standard Error 2.28
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale 80 mg Cocaine with 210 mg Phendimetrazine	10.1 units on a scale Standard Error 6.52

SECONDARY outcome

Timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Subjects rated their feelings of "Willing to Pay For" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.

Outcome measures

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale 0 mg Cocaine with 0 mg Phendimetrazine	.9 units on a scale Standard Error .9
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale 10 mg Cocaine with 0 mg Phendimetrazine	4.4 units on a scale Standard Error 2.49
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale 20 mg Cocaine with 0 mg Phendimetrazine	8.2 units on a scale Standard Error 3.53
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale 40 mg Cocaine with 0 mg Phendimetrazine	11.2 units on a scale Standard Error 4.59
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale 80 mg Cocaine with 0 mg Phendimetrazine	20.2 units on a scale Standard Error 7.01
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale 0 mg Cocaine with 70 mg Phendimetrazine	1.1 units on a scale Standard Error .72
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale 10 mg Cocaine with 70 mg Phendimetrazine	1.4 units on a scale Standard Error .86
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale 20 mg Cocaine with 70 mg Phendimetrazine	6.4 units on a scale Standard Error 2.9
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale 40 mg Cocaine with 70 mg Phendimetrazine	14.1 units on a scale Standard Error 4.62
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale 80 mg Cocaine with 70 mg Phendimetrazine	19.3 units on a scale Standard Error 5.63
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale 0 mg Cocaine with 140 mg Phendimetrazine	.8 units on a scale Standard Error .42
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale 10 mg Cocaine with 140 mg Phendimetrazine	3.2 units on a scale Standard Error 2.15
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale 20 mg Cocaine with 140 mg Phendimetrazine	7.9 units on a scale Standard Error 3.82
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale 40 mg Cocaine with 140 mg Phendimetrazine	18.3 units on a scale Standard Error 6.58
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale 80 mg Cocaine with 140 mg Phendimetrazine	23 units on a scale Standard Error 5.77
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale 0 mg Cocaine with 210 mg Phendimetrazine	1.7 units on a scale Standard Error 1.32
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale 10 mg Cocaine with 210 mg Phendimetrazine	6 units on a scale Standard Error 2.65
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale 20 mg Cocaine with 210 mg Phendimetrazine	8.9 units on a scale Standard Error 4.39
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale 40 mg Cocaine with 210 mg Phendimetrazine	12.3 units on a scale Standard Error 3.77
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale 80 mg Cocaine with 210 mg Phendimetrazine	23.1 units on a scale Standard Error 9.27

SECONDARY outcome

Timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Subjects rated their feelings of "Performance Impaired" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.

Outcome measures

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Peak Ratings of "Performance Impaired" on the Visual Analog Scale 20 mg Cocaine with 210 mg Phendimetrazine	7.6 units on a scale Standard Error 5.07
Peak Ratings of "Performance Impaired" on the Visual Analog Scale 0 mg Cocaine with 0 mg Phendimetrazine	.8 units on a scale Standard Error .7
Peak Ratings of "Performance Impaired" on the Visual Analog Scale 10 mg Cocaine with 0 mg Phendimetrazine	.7 units on a scale Standard Error .47
Peak Ratings of "Performance Impaired" on the Visual Analog Scale 20 mg Cocaine with 0 mg Phendimetrazine	1.9 units on a scale Standard Error .98
Peak Ratings of "Performance Impaired" on the Visual Analog Scale 40 mg Cocaine with 0 mg Phendimetrazine	3.3 units on a scale Standard Error 1.24
Peak Ratings of "Performance Impaired" on the Visual Analog Scale 80 mg Cocaine with 0 mg Phendimetrazine	3.4 units on a scale Standard Error 1.31
Peak Ratings of "Performance Impaired" on the Visual Analog Scale 0 mg Cocaine with 70 mg Phendimetrazine	1 units on a scale Standard Error .68
Peak Ratings of "Performance Impaired" on the Visual Analog Scale 10 mg Cocaine with 70 mg Phendimetrazine	2.2 units on a scale Standard Error 1.12
Peak Ratings of "Performance Impaired" on the Visual Analog Scale 20 mg Cocaine with 70 mg Phendimetrazine	.8 units on a scale Standard Error .55
Peak Ratings of "Performance Impaired" on the Visual Analog Scale 40 mg Cocaine with 70 mg Phendimetrazine	.7 units on a scale Standard Error .6
Peak Ratings of "Performance Impaired" on the Visual Analog Scale 80 mg Cocaine with 70 mg Phendimetrazine	4.9 units on a scale Standard Error 2.82
Peak Ratings of "Performance Impaired" on the Visual Analog Scale 0 mg Cocaine with 140 mg Phendimetrazine	.8 units on a scale Standard Error .42
Peak Ratings of "Performance Impaired" on the Visual Analog Scale 10 mg Cocaine with 140 mg Phendimetrazine	.7 units on a scale Standard Error .47
Peak Ratings of "Performance Impaired" on the Visual Analog Scale 20 mg Cocaine with 140 mg Phendimetrazine	4.5 units on a scale Standard Error 3.56
Peak Ratings of "Performance Impaired" on the Visual Analog Scale 40 mg Cocaine with 140 mg Phendimetrazine	2.1 units on a scale Standard Error 1
Peak Ratings of "Performance Impaired" on the Visual Analog Scale 80 mg Cocaine with 140 mg Phendimetrazine	3.7 units on a scale Standard Error 1.78
Peak Ratings of "Performance Impaired" on the Visual Analog Scale 0 mg Cocaine with 210 mg Phendimetrazine	.8 units on a scale Standard Error .55
Peak Ratings of "Performance Impaired" on the Visual Analog Scale 10 mg Cocaine with 210 mg Phendimetrazine	.3 units on a scale Standard Error .3
Peak Ratings of "Performance Impaired" on the Visual Analog Scale 40 mg Cocaine with 210 mg Phendimetrazine	4.4 units on a scale Standard Error 3.65
Peak Ratings of "Performance Impaired" on the Visual Analog Scale 80 mg Cocaine with 210 mg Phendimetrazine	7.6 units on a scale Standard Error 5.24

SECONDARY outcome

Timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Subjects rated their feelings of "Performance Improved" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.

Outcome measures

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Peak Ratings of "Performance Improved" on the Visual Analog Scale 0 mg Cocaine with 0 mg Phendimetrazine	.7 units on a scale Standard Error .6
Peak Ratings of "Performance Improved" on the Visual Analog Scale 10 mg Cocaine with 0 mg Phendimetrazine	.7 units on a scale Standard Error .42
Peak Ratings of "Performance Improved" on the Visual Analog Scale 20 mg Cocaine with 0 mg Phendimetrazine	1.4 units on a scale Standard Error .72
Peak Ratings of "Performance Improved" on the Visual Analog Scale 40 mg Cocaine with 0 mg Phendimetrazine	1.4 units on a scale Standard Error .6
Peak Ratings of "Performance Improved" on the Visual Analog Scale 80 mg Cocaine with 0 mg Phendimetrazine	6.6 units on a scale Standard Error 4.49
Peak Ratings of "Performance Improved" on the Visual Analog Scale 0 mg Cocaine with 70 mg Phendimetrazine	.7 units on a scale Standard Error .6
Peak Ratings of "Performance Improved" on the Visual Analog Scale 10 mg Cocaine with 70 mg Phendimetrazine	.6 units on a scale Standard Error .5
Peak Ratings of "Performance Improved" on the Visual Analog Scale 20 mg Cocaine with 70 mg Phendimetrazine	1.9 units on a scale Standard Error .91
Peak Ratings of "Performance Improved" on the Visual Analog Scale 40 mg Cocaine with 70 mg Phendimetrazine	4.8 units on a scale Standard Error 3.31
Peak Ratings of "Performance Improved" on the Visual Analog Scale 80 mg Cocaine with 70 mg Phendimetrazine	2.4 units on a scale Standard Error 1.15
Peak Ratings of "Performance Improved" on the Visual Analog Scale 0 mg Cocaine with 140 mg Phendimetrazine	.9 units on a scale Standard Error .6
Peak Ratings of "Performance Improved" on the Visual Analog Scale 10 mg Cocaine with 140 mg Phendimetrazine	.9 units on a scale Standard Error .6
Peak Ratings of "Performance Improved" on the Visual Analog Scale 20 mg Cocaine with 140 mg Phendimetrazine	.8 units on a scale Standard Error .61
Peak Ratings of "Performance Improved" on the Visual Analog Scale 40 mg Cocaine with 140 mg Phendimetrazine	3.6 units on a scale Standard Error 2.84
Peak Ratings of "Performance Improved" on the Visual Analog Scale 80 mg Cocaine with 140 mg Phendimetrazine	5.1 units on a scale Standard Error 3.58
Peak Ratings of "Performance Improved" on the Visual Analog Scale 0 mg Cocaine with 210 mg Phendimetrazine	1.9 units on a scale Standard Error 1.29
Peak Ratings of "Performance Improved" on the Visual Analog Scale 10 mg Cocaine with 210 mg Phendimetrazine	.5 units on a scale Standard Error .4
Peak Ratings of "Performance Improved" on the Visual Analog Scale 20 mg Cocaine with 210 mg Phendimetrazine	1.6 units on a scale Standard Error 1.06
Peak Ratings of "Performance Improved" on the Visual Analog Scale 40 mg Cocaine with 210 mg Phendimetrazine	3.9 units on a scale Standard Error 2.9
Peak Ratings of "Performance Improved" on the Visual Analog Scale 80 mg Cocaine with 210 mg Phendimetrazine	2.6 units on a scale Standard Error 1.65

SECONDARY outcome

Timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Subjects rated their feelings of "Restless" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.

Outcome measures

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Peak Ratings of "Restless" on the Visual Analog Scale 0 mg Cocaine with 0 mg Phendimetrazine	.5 units on a scale Standard Error .4
Peak Ratings of "Restless" on the Visual Analog Scale 10 mg Cocaine with 0 mg Phendimetrazine	1.9 units on a scale Standard Error 1.08
Peak Ratings of "Restless" on the Visual Analog Scale 20 mg Cocaine with 0 mg Phendimetrazine	.7 units on a scale Standard Error .6
Peak Ratings of "Restless" on the Visual Analog Scale 40 mg Cocaine with 0 mg Phendimetrazine	1.8 units on a scale Standard Error 1.01
Peak Ratings of "Restless" on the Visual Analog Scale 80 mg Cocaine with 0 mg Phendimetrazine	2.3 units on a scale Standard Error 1.32
Peak Ratings of "Restless" on the Visual Analog Scale 0 mg Cocaine with 70 mg Phendimetrazine	.5 units on a scale Standard Error .5
Peak Ratings of "Restless" on the Visual Analog Scale 10 mg Cocaine with 70 mg Phendimetrazine	.9 units on a scale Standard Error .53
Peak Ratings of "Restless" on the Visual Analog Scale 20 mg Cocaine with 70 mg Phendimetrazine	.7 units on a scale Standard Error .47
Peak Ratings of "Restless" on the Visual Analog Scale 40 mg Cocaine with 70 mg Phendimetrazine	1.1 units on a scale Standard Error .64
Peak Ratings of "Restless" on the Visual Analog Scale 80 mg Cocaine with 70 mg Phendimetrazine	1 units on a scale Standard Error .54
Peak Ratings of "Restless" on the Visual Analog Scale 0 mg Cocaine with 140 mg Phendimetrazine	1 units on a scale Standard Error .68
Peak Ratings of "Restless" on the Visual Analog Scale 10 mg Cocaine with 140 mg Phendimetrazine	1.8 units on a scale Standard Error .9
Peak Ratings of "Restless" on the Visual Analog Scale 20 mg Cocaine with 140 mg Phendimetrazine	2.3 units on a scale Standard Error 1.67
Peak Ratings of "Restless" on the Visual Analog Scale 40 mg Cocaine with 140 mg Phendimetrazine	4.1 units on a scale Standard Error 1.96
Peak Ratings of "Restless" on the Visual Analog Scale 80 mg Cocaine with 140 mg Phendimetrazine	4 units on a scale Standard Error 2.04
Peak Ratings of "Restless" on the Visual Analog Scale 0 mg Cocaine with 210 mg Phendimetrazine	1.6 units on a scale Standard Error .99
Peak Ratings of "Restless" on the Visual Analog Scale 10 mg Cocaine with 210 mg Phendimetrazine	2.7 units on a scale Standard Error 2.28
Peak Ratings of "Restless" on the Visual Analog Scale 20 mg Cocaine with 210 mg Phendimetrazine	2.0 units on a scale Standard Error 1.61
Peak Ratings of "Restless" on the Visual Analog Scale 40 mg Cocaine with 210 mg Phendimetrazine	3.6 units on a scale Standard Error 1.59
Peak Ratings of "Restless" on the Visual Analog Scale 80 mg Cocaine with 210 mg Phendimetrazine	6.9 units on a scale Standard Error 5.38

SECONDARY outcome

Timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Subjects rated their feelings of "Rush" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.

Outcome measures

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Peak Ratings of "Rush" on the Visual Analog Scale 0 mg Cocaine with 0 mg Phendimetrazine	.5 units on a scale Standard Error .5
Peak Ratings of "Rush" on the Visual Analog Scale 40 mg Cocaine with 70 mg Phendimetrazine	11.1 units on a scale Standard Error 4.32
Peak Ratings of "Rush" on the Visual Analog Scale 10 mg Cocaine with 140 mg Phendimetrazine	5.67 units on a scale Standard Error 2.12
Peak Ratings of "Rush" on the Visual Analog Scale 20 mg Cocaine with 210 mg Phendimetrazine	10.3 units on a scale Standard Error 3.62
Peak Ratings of "Rush" on the Visual Analog Scale 10 mg Cocaine with 0 mg Phendimetrazine	4.4 units on a scale Standard Error 2.4
Peak Ratings of "Rush" on the Visual Analog Scale 20 mg Cocaine with 0 mg Phendimetrazine	11.9 units on a scale Standard Error 4.53
Peak Ratings of "Rush" on the Visual Analog Scale 40 mg Cocaine with 0 mg Phendimetrazine	11.4 units on a scale Standard Error 5.93
Peak Ratings of "Rush" on the Visual Analog Scale 80 mg Cocaine with 0 mg Phendimetrazine	17.4 units on a scale Standard Error 7.06
Peak Ratings of "Rush" on the Visual Analog Scale 0 mg Cocaine with 70 mg Phendimetrazine	.9 units on a scale Standard Error .6
Peak Ratings of "Rush" on the Visual Analog Scale 10 mg Cocaine with 70 mg Phendimetrazine	3.4 units on a scale Standard Error 1.5
Peak Ratings of "Rush" on the Visual Analog Scale 20 mg Cocaine with 70 mg Phendimetrazine	8 units on a scale Standard Error 3.73
Peak Ratings of "Rush" on the Visual Analog Scale 80 mg Cocaine with 70 mg Phendimetrazine	20 units on a scale Standard Error 7.11
Peak Ratings of "Rush" on the Visual Analog Scale 0 mg Cocaine with 140 mg Phendimetrazine	1 units on a scale Standard Error .67
Peak Ratings of "Rush" on the Visual Analog Scale 20 mg Cocaine with 140 mg Phendimetrazine	9.2 units on a scale Standard Error 3.44
Peak Ratings of "Rush" on the Visual Analog Scale 40 mg Cocaine with 140 mg Phendimetrazine	16.3 units on a scale Standard Error 5.95
Peak Ratings of "Rush" on the Visual Analog Scale 80 mg Cocaine with 140 mg Phendimetrazine	21.8 units on a scale Standard Error 6.03
Peak Ratings of "Rush" on the Visual Analog Scale 0 mg Cocaine with 210 mg Phendimetrazine	1.4 units on a scale Standard Error .86
Peak Ratings of "Rush" on the Visual Analog Scale 10 mg Cocaine with 210 mg Phendimetrazine	7.3 units on a scale Standard Error 2.49
Peak Ratings of "Rush" on the Visual Analog Scale 40 mg Cocaine with 210 mg Phendimetrazine	13.2 units on a scale Standard Error 4.55
Peak Ratings of "Rush" on the Visual Analog Scale 80 mg Cocaine with 210 mg Phendimetrazine	16.9 units on a scale Standard Error 5.58

SECONDARY outcome

Timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Subjects rated their feelings of "Shaky/Jittery" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.

Outcome measures

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale 0 mg Cocaine with 0 mg Phendimetrazine	1.7 units on a scale Standard Error .88
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale 10 mg Cocaine with 0 mg Phendimetrazine	1.8 units on a scale Standard Error .88
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale 20 mg Cocaine with 0 mg Phendimetrazine	6.1 units on a scale Standard Error 3.14
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale 40 mg Cocaine with 0 mg Phendimetrazine	6 units on a scale Standard Error 3.78
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale 80 mg Cocaine with 0 mg Phendimetrazine	11.9 units on a scale Standard Error 7.28
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale 0 mg Cocaine with 70 mg Phendimetrazine	.4 units on a scale Standard Error .4
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale 10 mg Cocaine with 70 mg Phendimetrazine	.5 units on a scale Standard Error .5
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale 20 mg Cocaine with 70 mg Phendimetrazine	1.8 units on a scale Standard Error 1.05
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale 40 mg Cocaine with 70 mg Phendimetrazine	2.4 units on a scale Standard Error 1.61
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale 80 mg Cocaine with 70 mg Phendimetrazine	6.5 units on a scale Standard Error 3.39
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale 0 mg Cocaine with 140 mg Phendimetrazine	1.4 units on a scale Standard Error .79
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale 10 mg Cocaine with 140 mg Phendimetrazine	.9 units on a scale Standard Error .6
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale 20 mg Cocaine with 140 mg Phendimetrazine	3.8 units on a scale Standard Error 1.7
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale 40 mg Cocaine with 140 mg Phendimetrazine	3.9 units on a scale Standard Error 2.3
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale 80 mg Cocaine with 140 mg Phendimetrazine	12.8 units on a scale Standard Error 5.33
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale 0 mg Cocaine with 210 mg Phendimetrazine	.3 units on a scale Standard Error .3
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale 10 mg Cocaine with 210 mg Phendimetrazine	.8 units on a scale Standard Error .55
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale 20 mg Cocaine with 210 mg Phendimetrazine	1.9 units on a scale Standard Error 1.04
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale 40 mg Cocaine with 210 mg Phendimetrazine	6.6 units on a scale Standard Error 2.92
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale 80 mg Cocaine with 210 mg Phendimetrazine	9 units on a scale Standard Error 5.58

SECONDARY outcome

Timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Subjects rated their feelings of "Sluggish/Fatigued/Lazy" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.

Outcome measures

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale 0 mg Cocaine with 70 mg Phendimetrazine	.6 units on a scale Standard Error .43
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale 0 mg Cocaine with 0 mg Phendimetrazine	1.7 units on a scale Standard Error .9
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale 10 mg Cocaine with 0 mg Phendimetrazine	1.8 units on a scale Standard Error 1.09
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale 20 mg Cocaine with 0 mg Phendimetrazine	1.09 units on a scale Standard Error 1
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale 40 mg Cocaine with 0 mg Phendimetrazine	3.3 units on a scale Standard Error 1.81
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale 80 mg Cocaine with 0 mg Phendimetrazine	8.5 units on a scale Standard Error 5.85
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale 10 mg Cocaine with 70 mg Phendimetrazine	3.0 units on a scale Standard Error 1.96
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale 20 mg Cocaine with 70 mg Phendimetrazine	3.3 units on a scale Standard Error 2.47
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale 40 mg Cocaine with 70 mg Phendimetrazine	5.3 units on a scale Standard Error 3.53
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale 80 mg Cocaine with 70 mg Phendimetrazine	6 units on a scale Standard Error 3.53
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale 0 mg Cocaine with 140 mg Phendimetrazine	.7 units on a scale Standard Error .4
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale 10 mg Cocaine with 140 mg Phendimetrazine	4.8 units on a scale Standard Error 2.27
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale 20 mg Cocaine with 140 mg Phendimetrazine	4.6 units on a scale Standard Error 2.47
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale 40 mg Cocaine with 140 mg Phendimetrazine	5.3 units on a scale Standard Error 2.94
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale 80 mg Cocaine with 140 mg Phendimetrazine	10.9 units on a scale Standard Error 5.49
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale 0 mg Cocaine with 210 mg Phendimetrazine	7 units on a scale Standard Error 5.82
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale 10 mg Cocaine with 210 mg Phendimetrazine	5.5 units on a scale Standard Error 2.67
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale 20 mg Cocaine with 210 mg Phendimetrazine	4.8 units on a scale Standard Error 2.64
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale 40 mg Cocaine with 210 mg Phendimetrazine	4.2 units on a scale Standard Error 2.63
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale 80 mg Cocaine with 210 mg Phendimetrazine	8.8 units on a scale Standard Error 7.16

SECONDARY outcome

Timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Subjects rated their feelings of "Stimulated" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.

Outcome measures

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Peak Ratings of "Stimulated" on the Visual Analog Scale 10 mg Cocaine with 0 mg Phendimetrazine	2 units on a scale Standard Error .93
Peak Ratings of "Stimulated" on the Visual Analog Scale 20 mg Cocaine with 0 mg Phendimetrazine	5.6 units on a scale Standard Error 2.9
Peak Ratings of "Stimulated" on the Visual Analog Scale 0 mg Cocaine with 0 mg Phendimetrazine	1.8 units on a scale Standard Error .8
Peak Ratings of "Stimulated" on the Visual Analog Scale 40 mg Cocaine with 0 mg Phendimetrazine	5.1 units on a scale Standard Error 2.56
Peak Ratings of "Stimulated" on the Visual Analog Scale 80 mg Cocaine with 0 mg Phendimetrazine	10.8 units on a scale Standard Error 4.92
Peak Ratings of "Stimulated" on the Visual Analog Scale 0 mg Cocaine with 70 mg Phendimetrazine	.8 units on a scale Standard Error .53
Peak Ratings of "Stimulated" on the Visual Analog Scale 10 mg Cocaine with 70 mg Phendimetrazine	3.7 units on a scale Standard Error 1.55
Peak Ratings of "Stimulated" on the Visual Analog Scale 20 mg Cocaine with 70 mg Phendimetrazine	4.9 units on a scale Standard Error 2.61
Peak Ratings of "Stimulated" on the Visual Analog Scale 40 mg Cocaine with 70 mg Phendimetrazine	8.9 units on a scale Standard Error 4.42
Peak Ratings of "Stimulated" on the Visual Analog Scale 80 mg Cocaine with 70 mg Phendimetrazine	12.4 units on a scale Standard Error 4.53
Peak Ratings of "Stimulated" on the Visual Analog Scale 0 mg Cocaine with 140 mg Phendimetrazine	1.6 units on a scale Standard Error .82
Peak Ratings of "Stimulated" on the Visual Analog Scale 10 mg Cocaine with 140 mg Phendimetrazine	2.9 units on a scale Standard Error 1.28
Peak Ratings of "Stimulated" on the Visual Analog Scale 20 mg Cocaine with 140 mg Phendimetrazine	5.5 units on a scale Standard Error 3.59
Peak Ratings of "Stimulated" on the Visual Analog Scale 40 mg Cocaine with 140 mg Phendimetrazine	11.6 units on a scale Standard Error 5.36
Peak Ratings of "Stimulated" on the Visual Analog Scale 80 mg Cocaine with 140 mg Phendimetrazine	10.9 units on a scale Standard Error 5.12
Peak Ratings of "Stimulated" on the Visual Analog Scale 0 mg Cocaine with 210 mg Phendimetrazine	2.2 units on a scale Standard Error 1.14
Peak Ratings of "Stimulated" on the Visual Analog Scale 10 mg Cocaine with 210 mg Phendimetrazine	2.4 units on a scale Standard Error 1.56
Peak Ratings of "Stimulated" on the Visual Analog Scale 20 mg Cocaine with 210 mg Phendimetrazine	4.8 units on a scale Standard Error 2.45
Peak Ratings of "Stimulated" on the Visual Analog Scale 40 mg Cocaine with 210 mg Phendimetrazine	9.1 units on a scale Standard Error 3.52
Peak Ratings of "Stimulated" on the Visual Analog Scale 80 mg Cocaine with 210 mg Phendimetrazine	14.7 units on a scale Standard Error 6.91

SECONDARY outcome

Timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Subjects rated their feelings of "Willing to Take Again" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.

Outcome measures

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale 0 mg Cocaine with 0 mg Phendimetrazine	1.1 units on a scale Standard Error .66
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale 20 mg Cocaine with 70 mg Phendimetrazine	13 units on a scale Standard Error 3.86
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale 40 mg Cocaine with 70 mg Phendimetrazine	20.7 units on a scale Standard Error 5.96
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale 10 mg Cocaine with 0 mg Phendimetrazine	9.8 units on a scale Standard Error 5.13
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale 20 mg Cocaine with 0 mg Phendimetrazine	14.1 units on a scale Standard Error 5.44
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale 40 mg Cocaine with 0 mg Phendimetrazine	16.5 units on a scale Standard Error 7.26
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale 80 mg Cocaine with 0 mg Phendimetrazine	22.9 units on a scale Standard Error 8.82
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale 0 mg Cocaine with 70 mg Phendimetrazine	1.5 units on a scale Standard Error .89
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale 10 mg Cocaine with 70 mg Phendimetrazine	3.5 units on a scale Standard Error .96
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale 80 mg Cocaine with 70 mg Phendimetrazine	26.7 units on a scale Standard Error 7.53
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale 0 mg Cocaine with 140 mg Phendimetrazine	1 units on a scale Standard Error .63
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale 10 mg Cocaine with 140 mg Phendimetrazine	8.8 units on a scale Standard Error 4.12
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale 20 mg Cocaine with 140 mg Phendimetrazine	11.1 units on a scale Standard Error 4.8
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale 40 mg Cocaine with 140 mg Phendimetrazine	19.4 units on a scale Standard Error 5.81
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale 80 mg Cocaine with 140 mg Phendimetrazine	25.8 units on a scale Standard Error 5.2
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale 0 mg Cocaine with 210 mg Phendimetrazine	2 units on a scale Standard Error 1.32
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale 10 mg Cocaine with 210 mg Phendimetrazine	11.2 units on a scale Standard Error 5.20
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale 20 mg Cocaine with 210 mg Phendimetrazine	11.6 units on a scale Standard Error 4.69
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale 40 mg Cocaine with 210 mg Phendimetrazine	17.9 units on a scale Standard Error 5.15
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale 80 mg Cocaine with 210 mg Phendimetrazine	30 units on a scale Standard Error 8.78

SECONDARY outcome

Timeframe: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.

Subjects rated their feelings of "Talkative/Friendly" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.

Outcome measures

Measure	Phendimetrazine Dose Escalation n=10 Participants Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Cocaine was administered acutely after at least seven days of maintenance on each condition. Placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine.
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale 20 mg Cocaine with 140 mg Phendimetrazine	1.9 units on a scale Standard Error 1.04
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale 0 mg Cocaine with 0 mg Phendimetrazine	1 units on a scale Standard Error .6
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale 10 mg Cocaine with 0 mg Phendimetrazine	2.7 units on a scale Standard Error 1.28
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale 20 mg Cocaine with 0 mg Phendimetrazine	3.9 units on a scale Standard Error 2.96
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale 40 mg Cocaine with 0 mg Phendimetrazine	3.5 units on a scale Standard Error 2.4
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale 80 mg Cocaine with 0 mg Phendimetrazine	4.3 units on a scale Standard Error 2.82
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale 0 mg Cocaine with 70 mg Phendimetrazine	.6 units on a scale Standard Error .6
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale 10 mg Cocaine with 70 mg Phendimetrazine	2.7 units on a scale Standard Error 1.21
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale 20 mg Cocaine with 70 mg Phendimetrazine	5.4 units on a scale Standard Error 2.63
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale 40 mg Cocaine with 70 mg Phendimetrazine	7.3 units on a scale Standard Error 3.09
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale 80 mg Cocaine with 70 mg Phendimetrazine	8 units on a scale Standard Error 3.87
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale 0 mg Cocaine with 140 mg Phendimetrazine	1 units on a scale Standard Error .68
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale 10 mg Cocaine with 140 mg Phendimetrazine	1.2 units on a scale Standard Error .81
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale 40 mg Cocaine with 140 mg Phendimetrazine	3.2 units on a scale Standard Error 1.65
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale 80 mg Cocaine with 140 mg Phendimetrazine	7.2 units on a scale Standard Error 2.74
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale 0 mg Cocaine with 210 mg Phendimetrazine	.7 units on a scale Standard Error .47
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale 10 mg Cocaine with 210 mg Phendimetrazine	.5 units on a scale Standard Error .34
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale 20 mg Cocaine with 210 mg Phendimetrazine	1.9 units on a scale Standard Error .92
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale 40 mg Cocaine with 210 mg Phendimetrazine	1.7 units on a scale Standard Error 1.11
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale 80 mg Cocaine with 210 mg Phendimetrazine	3.4 units on a scale Standard Error 1.43

Adverse Events

Phendimetrazine Dose Escalation

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Phendimetrazine Dose Escalation n=11 participants at risk Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order. Intranasal cocaine (10, 20, 40 and 80 mg) was administered acutely after at least seven days of maintenance on each condition. Intransasal placebo cocaine was administered acutely after at least seven days of maintenance on each condition. Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine. Placebo: The pharmacodynamic effects of placebo were determined during maintenance on placebo and phendimetrazine.

Cardiac disorders Persistent Tachycardia

9.1% 1/11 • Number of events 1

Additional Information

William W. Stoops, Ph.D.

University of Kentucky

Phone: 859-257-5388

Email: william.stoops@uky.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place