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Trial · NCT01639157

Impact of Buspirone Maintenance on the Reinforcing Effects of Cocaine

NCT01639157, Not applicable, Completed, William Stoops; results first posted 2016-02-19

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Impact of Buspirone Maintenance on the Reinforcing Effects of Cocaine. Trials, record NCT01639157. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01639157

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Trial

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

Title
Impact of Buspirone Maintenance on the Reinforcing Effects of Cocaine
NCT number
NCT01639157
Status
Completed
Phases
Not applicable
Enrollment
9 participants, actual
Lead sponsor
William Stoops
Conditions
Cocaine Use Disorders
Interventions
Buspirone, Placebo
First posted
2012-07-12
Last updated
2016-02-19
Results first posted
2016-02-19

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 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 buspirone 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 buspirone and placebo conditions.
SecondaryPeak Systolic Blood PressureThis measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone 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 2 week inpatient admissionNumber 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 buspirone and placebo maintenance conditions.arbitrary units on a Likert-type scaleMEAN
SECONDARYPeak Systolic Blood PressureThis measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.mmHgMEAN
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 buspirone and placebo maintenance conditions.arbitrary units on a Likert-type 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 buspirone and placebo maintenance conditions.arbitary units on a Visual Analog 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 buspirone and placebo maintenance conditions.arbitary units on a Visual Analog 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 buspirone and placebo maintenance conditions.arbitary units on a Visual Analog 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 buspirone and placebo maintenance conditions.arbitary units on a Visual Analog 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 buspirone and placebo maintenance conditions.arbitary units on a Visual Analog 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 buspirone and placebo maintenance conditions.arbitary units on a Visual Analog 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 AlternativeBuspirone0 mg Cocaine1.00Standard Error 0.707Number of Cocaine Choices
Number of Times Cocaine Was Selected in the Presence of a Monetary Reward AlternativePlacebo0 mg Cocaine1.22Standard Error 0.813Number of Cocaine Choices
Number of Times Cocaine Was Selected in the Presence of a Monetary Reward AlternativeBuspirone15 mg Cocaine5.56Standard Error 0.338Number of Cocaine Choices
Number of Times Cocaine Was Selected in the Presence of a Monetary Reward AlternativePlacebo15 mg Cocaine5.33Standard Error 0.441Number of Cocaine Choices
Number of Times Cocaine Was Selected in the Presence of a Monetary Reward AlternativeBuspirone45 mg Cocaine5Standard Error .289Number of Cocaine Choices
Number of Times Cocaine Was Selected in the Presence of a Monetary Reward AlternativePlacebo45 mg Cocaine4.89Standard Error .455Number of Cocaine Choices
Peak Score on Sedative Subscale of the Adjective Rating ScaleBuspirone0 mg Cocaine2.9Standard Error 1.3arbitrary units on a Likert-type scale
Peak Score on Sedative Subscale of the Adjective Rating ScalePlacebo0 mg Cocaine3.6Standard Error 1.6arbitrary units on a Likert-type scale
Peak Score on Sedative Subscale of the Adjective Rating ScaleBuspirone15 mg Cocaine4.4Standard Error 1.7arbitrary units on a Likert-type scale
Peak Score on Sedative Subscale of the Adjective Rating ScalePlacebo15 mg Cocaine4.8Standard Error 1.8arbitrary units on a Likert-type scale

Participant flow6

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

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDBuspirone Then Placebo4
Overall StudySTARTEDPlacebo Then Buspirone5
Overall StudyCOMPLETEDBuspirone Then Placebo4
Overall StudyCOMPLETEDPlacebo Then Buspirone5
Overall StudyNOT COMPLETEDBuspirone Then Placebo0
Overall StudyNOT COMPLETEDPlacebo Then Buspirone0

Adverse events0

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

None in this release.

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityBuspirone
Total, all-cause mortalityPlacebo
Total, other adverse eventsBuspirone09
Total, other adverse eventsPlacebo09
Total, serious adverse eventsBuspirone09
Total, serious adverse eventsPlacebo09

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
20638380BACKGROUND

Source PubMed

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
R21DA034095A Human Laboratory Study to Investigate Buspirone for Cocaine Use DisordersSTOOPS, WILLIAM WALTONUNIVERSITY OF KENTUCKYNATIONAL INSTITUTE ON DRUG ABUSE2012 to 2013

Trial comparisons1

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

Comparison
Buspirone vs 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.

For software

Read this trial from software.

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

GET https://conductscience.org/api/trials/v1/NCT01639157

GET https://conductscience.org/api/trials/v1/NCT01639157/registered?page=2