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Trial · NCT02141620

n-Acetylcysteine and Cocaine

NCT02141620, Early phase 1, Completed, University of Kentucky; results first posted 2016-10-06

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. n-Acetylcysteine and Cocaine. Trials, record NCT02141620. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02141620

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
n-Acetylcysteine and Cocaine
NCT number
NCT02141620
Status
Completed
Phases
Early phase 1
Enrollment
15 participants, actual
Lead sponsor
University of Kentucky
Conditions
Cocaine Abuse, Cocaine Dependence
Interventions
Cocaine, n-Acetylcysteine, Placebo
First posted
2014-05-19
Last updated
2017-01-04
Results first posted
2016-10-06

Source ClinicalTrials.gov

Registered outcomes27

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of Times Cocaine Was Selected in the Presence of a Monetary Reward AlternativeOne 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.
SecondaryPeak Score on Sedative Subscale of the Adjective Rating ScaleSubjects 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.
SecondaryPeak Score on Stimulant Subscale of the Adjective Rating ScaleSubjects 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.
SecondaryPeak Ratings of "Active, Alert, Energetic" on the Visual Analog ScaleSubjects 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.
SecondaryPeak Ratings of "Any Effect" on the Visual Analog ScaleSubjects 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.
SecondaryPeak Ratings of "Bad Effects" on the Visual Analog ScaleSubjects 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.
SecondaryPeak Ratings of "Euphoric" on the Visual Analog ScaleSubjects 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.
SecondaryPeak Ratings of "Good Effects" on the Visual Analog ScaleSubjects 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.
SecondaryPeak Ratings of "High" on the Visual Analog ScaleSubjects 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.
SecondaryPeak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog ScaleSubjects 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.

Outcomes27

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Times Cocaine Was Selected in the Presence of a Monetary Reward AlternativeOne test per cocaine dose level per intervention for each participant over his/her approximate 2 week inpatient admission.Number of Cocaine ChoicesMEAN
SECONDARYPeak Score on Sedative Subscale of the Adjective Rating ScaleSubjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.units on a scaleMEAN
SECONDARYPeak Score on Stimulant Subscale of the Adjective Rating ScaleSubjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.units on a scaleMEAN
SECONDARYPeak Ratings of Active, Alert, Energetic on the Visual Analog ScaleSubjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.units on a scaleMEAN
SECONDARYPeak Ratings of Any Effect on the Visual Analog ScaleSubjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.units on a scaleMEAN
SECONDARYPeak Ratings of Bad Effects on the Visual Analog ScaleSubjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.units on a scaleMEAN
SECONDARYPeak Ratings of Euphoric on the Visual Analog ScaleSubjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.units on a scaleMEAN
SECONDARYPeak Ratings of Good Effects on the Visual Analog ScaleSubjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.units on a scaleMEAN
SECONDARYPeak Ratings of High on the Visual Analog ScaleSubjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.units on a scaleMEAN
SECONDARYPeak Ratings of Irregular/Racing Heartbeat on the Visual Analog ScaleSubjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.units on a scaleMEAN

Results by group162

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Number of Times Cocaine Was Selected in the Presence of a Monetary Reward AlternativePlaceboPlacebo Cocaine1.0Standard Deviation 2.2Number of Cocaine Choices
Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternativen-AcetylcysteinePlacebo Cocaine0.1Standard Deviation .5Number of Cocaine Choices
Number of Times Cocaine Was Selected in the Presence of a Monetary Reward AlternativePlacebo30 mg Cocaine3.4Standard Deviation 2.6Number of Cocaine Choices
Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternativen-Acetylcysteine30 mg Cocaine3.9Standard Deviation 2.4Number of Cocaine Choices
Number of Times Cocaine Was Selected in the Presence of a Monetary Reward AlternativePlacebo60 mg Cocaine3.5Standard Deviation 2.8Number of Cocaine Choices
Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternativen-Acetylcysteine60 mg Cocaine3.9Standard Deviation 2.4Number of Cocaine Choices
Peak Score on Sedative Subscale of the Adjective Rating ScalePlaceboPlacebo Cocaine3.8Standard Error 1.2units on a scale
Peak Score on Sedative Subscale of the Adjective Rating Scalen-AcetylcysteinePlacebo Cocaine3.9Standard Error 1.4units on a scale
Peak Score on Sedative Subscale of the Adjective Rating ScalePlacebo30 mg Cocaine2.5Standard Error .9units on a scale
Peak Score on Sedative Subscale of the Adjective Rating Scalen-Acetylcysteine30 mg Cocaine2.4Standard Error .8units on a scale

Participant flow12

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Treatment Condition 1 (7 Days)STARTEDPlacebo Then n-Acetylcysteine8
Treatment Condition 1 (7 Days)STARTEDn-Acetylcysteine Then Placebo7
Treatment Condition 1 (7 Days)COMPLETEDPlacebo Then n-Acetylcysteine7
Treatment Condition 1 (7 Days)COMPLETEDn-Acetylcysteine Then Placebo7
Treatment Condition 1 (7 Days)NOT COMPLETEDPlacebo Then n-Acetylcysteine1
Treatment Condition 1 (7 Days)NOT COMPLETEDn-Acetylcysteine Then Placebo0
Treatment Condition 2 (7 Days)STARTEDPlacebo Then n-Acetylcysteine7
Treatment Condition 2 (7 Days)STARTEDn-Acetylcysteine Then Placebo7
Treatment Condition 2 (7 Days)COMPLETEDPlacebo Then n-Acetylcysteine7
Treatment Condition 2 (7 Days)COMPLETEDn-Acetylcysteine Then Placebo7

Adverse events2

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherTooth PainGeneral disordersPlacebo Then n-Acetylcysteine181
otherTooth PainGeneral disordersn-Acetylcysteine Then Placebo070

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityPlacebo Then n-Acetylcysteine
Total, all-cause mortalityn-Acetylcysteine Then Placebo
Total, other adverse eventsPlacebo Then n-Acetylcysteine18
Total, other adverse eventsn-Acetylcysteine Then Placebo07
Total, serious adverse eventsPlacebo Then n-Acetylcysteine08
Total, serious adverse eventsn-Acetylcysteine Then Placebo07

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
R21DA035376Motivation for Cocaine and Non-Drug Reinforcers: Targeting Glutamate HomeostasisSTOOPS, WILLIAM WALTONUNIVERSITY OF KENTUCKYNATIONAL INSTITUTE ON DRUG ABUSE2014 to 2015

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Placebo Then n-Acetylcysteine vs n-Acetylcysteine Then Placebo: serious adverse events

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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The record and each of its lists are JSON, twenty rows a page. No key.

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GET https://conductscience.org/api/trials/v1/NCT02141620/registered?page=2