Trial Outcomes & Findings for n-Acetylcysteine and Cocaine (NCT NCT02141620)

NCT ID: NCT02141620

Last Updated: 2017-01-04

Results Overview

The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Stoops et al., 2010) in which subjects made 6 choices between available each available cocaine dose and money (US$0.25). Reinforcing effects are measured for each cocaine dose during both buspirone and placebo maintenance.

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 15 participants
• Primary outcome timeframe: One test per cocaine dose level per intervention for each participant over his/her approximate 2 week inpatient admission.
• Results posted on: 2017-01-04

Participant Flow

Participant milestones

Measure	Placebo Then n-Acetylcysteine Subjects were maintained on placebo for 7 days, then they were crossed over to 2.4 g n-acetylcysteine daily for 7 days.	n-Acetylcysteine Then Placebo Subjects were maintained on 2.4 g n-acetylcysteine for 7 days, then they were crossed over to placebo daily for 7 days.
Treatment Condition 1 (7 Days) STARTED	8	7
Treatment Condition 1 (7 Days) COMPLETED	7	7
Treatment Condition 1 (7 Days) NOT COMPLETED	1	0
Treatment Condition 2 (7 Days) STARTED	7	7
Treatment Condition 2 (7 Days) COMPLETED	7	7
Treatment Condition 2 (7 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Placebo Then n-Acetylcysteine Subjects were maintained on placebo for 7 days, then they were crossed over to 2.4 g n-acetylcysteine daily for 7 days.	n-Acetylcysteine Then Placebo Subjects were maintained on 2.4 g n-acetylcysteine for 7 days, then they were crossed over to placebo daily for 7 days.
Treatment Condition 1 (7 Days) Adverse Event	1	0

Baseline Characteristics

n-Acetylcysteine and Cocaine

Baseline characteristics by cohort

Measure	All Study Participants n=14 Participants All subjects who completed the study.
Age, Continuous	42.6 years STANDARD_DEVIATION 5.4 • n=5 Participants
Gender Female	3 Participants n=5 Participants
Gender Male	11 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: One test per cocaine dose level per intervention for each participant over his/her approximate 2 week inpatient admission.

The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Stoops et al., 2010) in which subjects made 6 choices between available each available cocaine dose and money (US$0.25). Reinforcing effects are measured for each cocaine dose during both buspirone and placebo maintenance.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative Placebo Cocaine	1.0 Number of Cocaine Choices Standard Deviation 2.2	0.1 Number of Cocaine Choices Standard Deviation .5
Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative 30 mg Cocaine	3.4 Number of Cocaine Choices Standard Deviation 2.6	3.9 Number of Cocaine Choices Standard Deviation 2.4
Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative 60 mg Cocaine	3.5 Number of Cocaine Choices Standard Deviation 2.8	3.9 Number of Cocaine Choices Standard Deviation 2.4

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine 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 n-acetylcysteine and placebo conditions.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Peak Score on Sedative Subscale of the Adjective Rating Scale 30 mg Cocaine	2.5 units on a scale Standard Error .9	2.4 units on a scale Standard Error .8
Peak Score on Sedative Subscale of the Adjective Rating Scale Placebo Cocaine	3.8 units on a scale Standard Error 1.2	3.9 units on a scale Standard Error 1.4
Peak Score on Sedative Subscale of the Adjective Rating Scale 60 mg Cocaine	2.6 units on a scale Standard Error .92	2.6 units on a scale Standard Error .8

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine 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 "sedative" 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 n-acetylcysteine and placebo conditions.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Peak Score on Stimulant Subscale of the Adjective Rating Scale 60 mg Cocaine	12.2 units on a scale Standard Error 1.9	11.6 units on a scale Standard Error 1.5
Peak Score on Stimulant Subscale of the Adjective Rating Scale Placebo Cocaine	6.1 units on a scale Standard Error 1.1	5.7 units on a scale Standard Error 1.1
Peak Score on Stimulant Subscale of the Adjective Rating Scale 30 mg Cocaine	9.8 units on a scale Standard Error 1.4	9.1 units on a scale Standard Error 1.4

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine 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 n-acetylcysteine and placebo conditions.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale Placebo Cocaine	2.4 units on a scale Standard Error 1.3	.9 units on a scale Standard Error .44
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale 30 mg Cocaine	14.7 units on a scale Standard Error 5.7	13.9 units on a scale Standard Error 4.4
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale 60 mg Cocaine	27.1 units on a scale Standard Error 6.6	20.5 units on a scale Standard Error 6.6

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine 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 n-acetylcysteine and placebo conditions.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Peak Ratings of "Any Effect" on the Visual Analog Scale Placebo Cocaine	1.1 units on a scale Standard Error .5	1.4 units on a scale Standard Error .8
Peak Ratings of "Any Effect" on the Visual Analog Scale 30 mg Cocaine	19.6 units on a scale Standard Error 4.4	16.7 units on a scale Standard Error 4.9
Peak Ratings of "Any Effect" on the Visual Analog Scale 60 mg Cocaine	25.7 units on a scale Standard Error 5.8	28.2 units on a scale Standard Error 7.0

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.

Subjects rated their feelings of "Bad Effects" 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 n-acetylcysteine and placebo conditions.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Peak Ratings of "Bad Effects" on the Visual Analog Scale 30 mg Cocaine	4.2 units on a scale Standard Error 1.8	3.9 units on a scale Standard Error 1.7
Peak Ratings of "Bad Effects" on the Visual Analog Scale Placebo Cocaine	1.2 units on a scale Standard Error .5	1.1 units on a scale Standard Error .5
Peak Ratings of "Bad Effects" on the Visual Analog Scale 60 mg Cocaine	10.1 units on a scale Standard Error 4	7.2 units on a scale Standard Error 4.0

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine 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 n-acetylcysteine and placebo conditions.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Peak Ratings of "Euphoric" on the Visual Analog Scale Placebo Cocaine	2.6 units on a scale Standard Error 1.5	1.1 units on a scale Standard Error .5
Peak Ratings of "Euphoric" on the Visual Analog Scale 30 mg Cocaine	9.4 units on a scale Standard Error 4.3	3.1 units on a scale Standard Error 1.5
Peak Ratings of "Euphoric" on the Visual Analog Scale 60 mg Cocaine	15.1 units on a scale Standard Error 5.7	7.9 units on a scale Standard Error 3.7

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.

Subjects rated their feelings of "Good Effects" 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 n-acetylcysteine and placebo conditions.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Peak Ratings of "Good Effects" on the Visual Analog Scale Placebo Cocaine	1.1 units on a scale Standard Error .4	1.3 units on a scale Standard Error .7
Peak Ratings of "Good Effects" on the Visual Analog Scale 30 mg Cocaine	14.8 units on a scale Standard Error 4.4	16.7 units on a scale Standard Error 4.6
Peak Ratings of "Good Effects" on the Visual Analog Scale 60 mg Cocaine	25.3 units on a scale Standard Error 6.4	22.1 units on a scale Standard Error 4.6

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine 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 n-acetylcysteine and placebo conditions.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Peak Ratings of "High" on the Visual Analog Scale 30 mg Cocaine	18.2 units on a scale Standard Error 5.9	16.9 units on a scale Standard Error 4.4
Peak Ratings of "High" on the Visual Analog Scale 60 mg Cocaine	29.3 units on a scale Standard Error 6.9	27.1 units on a scale Standard Error 7.7
Peak Ratings of "High" on the Visual Analog Scale Placebo Cocaine	.9 units on a scale Standard Error .4	1.4 units on a scale Standard Error .8

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine 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 n-acetylcysteine and placebo conditions.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale Placebo Cocaine	1.9 units on a scale Standard Error 1	1.1 units on a scale Standard Error .53
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale 30 mg Cocaine	8.4 units on a scale Standard Error 3.4	5 units on a scale Standard Error 3.3
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale 60 mg Cocaine	13.6 units on a scale Standard Error 5.2	15.6 units on a scale Standard Error 5.6

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine 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 n-acetylcysteine and placebo conditions.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Peak Ratings of "Like Drug" on the Visual Analog Scale Placebo Cocaine	2.4 units on a scale Standard Error 1.3	2.3 units on a scale Standard Error 1.3
Peak Ratings of "Like Drug" on the Visual Analog Scale 30 mg Cocaine	20.8 units on a scale Standard Error 5	19.7 units on a scale Standard Error 5.1
Peak Ratings of "Like Drug" on the Visual Analog Scale 60 mg Cocaine	31.7 units on a scale Standard Error 7.4	26.9 units on a scale Standard Error 7.1

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.

Subjects rated their feelings of "Nauseous" 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 n-acetylcysteine and placebo conditions.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Peak Ratings of "Nauseous" on the Visual Analog Scale Placebo Cocaine	.9 units on a scale Standard Error .4	3.9 units on a scale Standard Error 2.7
Peak Ratings of "Nauseous" on the Visual Analog Scale 30 mg Cocaine	2.5 units on a scale Standard Error 1.1	1.3 units on a scale Standard Error .5
Peak Ratings of "Nauseous" on the Visual Analog Scale 60 mg Cocaine	8.1 units on a scale Standard Error 4	7.4 units on a scale Standard Error 4

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine 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 n-acetylcysteine and placebo conditions.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale Placebo Cocaine	2.4 units on a scale Standard Error 1.4	.9 units on a scale Standard Error .4
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale 30 mg Cocaine	2.3 units on a scale Standard Error .9	.9 units on a scale Standard Error .4
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale 60 mg Cocaine	7.5 units on a scale Standard Error 3	9.1 units on a scale Standard Error 4.2

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine 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 n-acetylcysteine and placebo conditions.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale Placebo Cocaine	2.4 units on a scale Standard Error 1.8	3.6 units on a scale Standard Error 2.8
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale 30 mg Cocaine	21 units on a scale Standard Error 7.6	19.2 units on a scale Standard Error 6.0
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale 60 mg Cocaine	33.9 units on a scale Standard Error 9.5	31.3 units on a scale Standard Error 8.1

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine 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 n-acetylcysteine and placebo conditions.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Peak Ratings of "Performance Impaired" on the Visual Analog Scale Placebo Cocaine	1.3 units on a scale Standard Error .5	1.4 units on a scale Standard Error .6
Peak Ratings of "Performance Impaired" on the Visual Analog Scale 30 mg Cocaine	3.1 units on a scale Standard Error 1.3	2.9 units on a scale Standard Error 1.2
Peak Ratings of "Performance Impaired" on the Visual Analog Scale 60 mg Cocaine	3.8 units on a scale Standard Error 2.1	7 units on a scale Standard Error 3.6

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine 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 n-acetylcysteine and placebo conditions.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Peak Ratings of "Performance Improved" on the Visual Analog Scale Placebo Cocaine	1.5 units on a scale Standard Error .7	.9 units on a scale Standard Error .4
Peak Ratings of "Performance Improved" on the Visual Analog Scale 30 mg Cocaine	7.3 units on a scale Standard Error 3.4	6.1 units on a scale Standard Error 3.9
Peak Ratings of "Performance Improved" on the Visual Analog Scale 60 mg Cocaine	10.1 units on a scale Standard Error 5.1	3.5 units on a scale Standard Error 1.6

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine 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 n-acetylcysteine and placebo conditions.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Peak Ratings of "Restless" on the Visual Analog Scale Placebo Cocaine	1.0 units on a scale Standard Error .42	1.0 units on a scale Standard Error .39
Peak Ratings of "Restless" on the Visual Analog Scale 30 mg Cocaine	3 units on a scale Standard Error 1.0	1.1 units on a scale Standard Error .4
Peak Ratings of "Restless" on the Visual Analog Scale 60 mg Cocaine	3.4 units on a scale Standard Error 1.5	3.2 units on a scale Standard Error 1.6

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine 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 n-acetylcysteine and placebo conditions.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Peak Ratings of "Rush" on the Visual Analog Scale Placebo Cocaine	1.2 units on a scale Standard Error .6	.9 units on a scale Standard Error .4
Peak Ratings of "Rush" on the Visual Analog Scale 60 mg Cocaine	24.6 units on a scale Standard Error 7	24.8 units on a scale Standard Error 7.6
Peak Ratings of "Rush" on the Visual Analog Scale 30 mg Cocaine	12.1 units on a scale Standard Error 4.4	10.8 units on a scale Standard Error 4.1

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine 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 n-acetylcysteine and placebo conditions.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale Placebo Cocaine	2.3 units on a scale Standard Error 1.3	1.3 units on a scale Standard Error .7
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale 60 mg Cocaine	14.6 units on a scale Standard Error 5	14.7 units on a scale Standard Error 5.5
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale 30 mg Cocaine	6.1 units on a scale Standard Error 2.4	8.1 units on a scale Standard Error 3.9

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine 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 n-acetylcysteine and placebo conditions.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale Placebo Cocaine	1.1 units on a scale Standard Error .5	1 units on a scale Standard Error .49
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale 30 mg Cocaine	1.3 units on a scale Standard Error .6	1.6 units on a scale Standard Error .9
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale 60 mg Cocaine	4.9 units on a scale Standard Error 1.9	2.1 units on a scale Standard Error 1.1

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine 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 n-acetylcysteine and placebo conditions.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Peak Ratings of "Stimulated" on the Visual Analog Scale 60 mg Cocaine	22.1 units on a scale Standard Error 6.2	18.3 units on a scale Standard Error 5.6
Peak Ratings of "Stimulated" on the Visual Analog Scale Placebo Cocaine	1.1 units on a scale Standard Error .4	1.2 units on a scale Standard Error .4
Peak Ratings of "Stimulated" on the Visual Analog Scale 30 mg Cocaine	13.7 units on a scale Standard Error 4.2	7.5 units on a scale Standard Error 3.8

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine 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 n-acetylcysteine and placebo conditions.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale Placebo Cocaine	4.2 units on a scale Standard Error 2.5	4.1 units on a scale Standard Error 2.4
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale 30 mg Cocaine	27.6 units on a scale Standard Error 7.5	24.9 units on a scale Standard Error 6.4
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale 60 mg Cocaine	35.4 units on a scale Standard Error 8.3	32.2 units on a scale Standard Error 8.4

SECONDARY outcome

Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine 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 n-acetylcysteine and placebo conditions.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale Placebo Cocaine	2.2 units on a scale Standard Error 1.1	.9 units on a scale Standard Error .4
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale 30 mg Cocaine	9.5 units on a scale Standard Error 4.4	11.4 units on a scale Standard Error 4.2
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale 60 mg Cocaine	22.3 units on a scale Standard Error 8.2	14.5 units on a scale Standard Error 5.3

SECONDARY outcome

Timeframe: This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine 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 n-acetylcysteine and placebo conditions.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Peak Diastolic Blood Pressure 60 mg Cocaine	82.4 mm Hg Standard Error 3.0	79.9 mm Hg Standard Error 2.4
Peak Diastolic Blood Pressure Placebo Cocaine	75.9 mm Hg Standard Error 2.2	74.9 mm Hg Standard Error 2.3
Peak Diastolic Blood Pressure 30 mg Cocaine	81.1 mm Hg Standard Error 1.8	82.3 mm Hg Standard Error 2.4

SECONDARY outcome

Timeframe: This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine 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 n-acetylcysteine and placebo conditions.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Peak Systolic Blood Pressure 60 mg Cocaine	131.1 mm Hg Standard Error 2.7	127.3 mm Hg Standard Error 3.7
Peak Systolic Blood Pressure Placebo Cocaine	117.9 mm Hg Standard Error 2.9	117.2 mm Hg Standard Error 3.4
Peak Systolic Blood Pressure 30 mg Cocaine	128.5 mm Hg Standard Error 2.7	128.6 mm Hg Standard Error 3.6

SECONDARY outcome

Timeframe: This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine 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 n-acetylcysteine and placebo conditions.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Peak Heart Rate Placebo Cocaine	72.4 beats per minute Standard Error 1.8	73.6 beats per minute Standard Error 2.5
Peak Heart Rate 30 mg Cocaine	82.2 beats per minute Standard Error 4.4	74.9 beats per minute Standard Error 2.5
Peak Heart Rate 60 mg Cocaine	84.3 beats per minute Standard Error 4.3	85.4 beats per minute Standard Error 4.4

SECONDARY outcome

Timeframe: This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine 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 n-acetylcysteine and placebo conditions.

Outcome measures

Measure	Placebo n=14 Participants Subjects were maintained on Placebo for 7 days.	n-Acetylcysteine n=14 Participants Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
Peak Temperature Placebo Cocaine	98.3 degrees Fahrenheit Standard Error .1	98.3 degrees Fahrenheit Standard Error .1
Peak Temperature 30 mg Cocaine	98.4 degrees Fahrenheit Standard Error .1	98.3 degrees Fahrenheit Standard Error .1
Peak Temperature 60 mg Cocaine	98.3 degrees Fahrenheit Standard Error .1	98.3 degrees Fahrenheit Standard Error .1

Adverse Events

Placebo Then n-Acetylcysteine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

n-Acetylcysteine Then Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo Then n-Acetylcysteine n=8 participants at risk Subjects were maintained on placebo for 7 days, then they were crossed over to 2.4 g n-acetylcysteine daily for 7 days.	n-Acetylcysteine Then Placebo n=7 participants at risk Subjects were maintained on 2.4 g n-acetylcysteine for 7 days, then they were crossed over to placebo daily for 7 days.
General disorders Tooth Pain	12.5% 1/8 • Number of events 1	0.00% 0/7

Additional Information

William W. Stoops

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