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Trial · NCT01843205

Buspirone as a Candidate Medication for Methamphetamine Abuse

NCT01843205, Phase 1, Completed, University of Kentucky; results first posted 2018-02-07

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ConductScience Library. Buspirone as a Candidate Medication for Methamphetamine Abuse. Trials, record NCT01843205. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01843205

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Trial

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

Title
Buspirone as a Candidate Medication for Methamphetamine Abuse
NCT number
NCT01843205
Status
Completed
Phases
Phase 1
Enrollment
9 participants, actual
Lead sponsor
University of Kentucky
Conditions
Methamphetamine Dependence, Methamphetamine Abuse
Interventions
Methamphetamine, Placebo
First posted
2013-04-30
Last updated
2018-02-07
Results first posted
2018-02-07

Source ClinicalTrials.gov

Registered outcomes27

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

ListOutcomeTime frameDescription
PrimaryNumber of Methamphetamine Doses Self-AdministeredOne test per methamphetamine dose level per intervention for each participant over his/her approximate 25 day inpatient admission
The reinforcing effects of methamphetamine will be determined during placebo and buspirone treatment using a modified progressive ratio procedure in which subjects are offered the opportunity to earn previously sampled doses of methamphetamine. Each ratio completed on the task will earn 1/10th of the sampled dose.
SecondaryPeak Score on Sedative Subscale of the Adjective Rating ScaleSubjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine 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 methamphetamine dose under both bupsirone and placebo conditions.
SecondaryPeak Score on Stimulant Subscale of the Adjective Rating ScaleSubjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine 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 "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 methamphetamine dose under both bupsirone and placebo conditions.
SecondaryPeak Ratings of "Active, Alert, Energetic" on the Visual Analog ScaleSubjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine 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 methamphetamine 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 2 hours after sampling each methamphetamine 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 methamphetamine 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 2 hours after sampling each methamphetamine 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 methamphetamine dose under both buspirone and placebo conditions.
SecondaryPeak Ratings of "Euphoric" on the Visual Analog ScaleSubjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine 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 methamphetamine 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 2 hours after sampling each methamphetamine 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 methamphetamine dose under both buspirone and placebo conditions.
SecondaryPeak Ratings of "High" on the Visual Analog ScaleSubjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine 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 methamphetamine dose under both buspirone and placebo conditions.
SecondaryPeak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog ScaleSubjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone 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 methamphetamine 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 Methamphetamine Doses Self-AdministeredOne test per methamphetamine dose level per intervention for each participant over his/her approximate 25 day inpatient admissionNumber of Methamphetamine DosesMEAN
SECONDARYPeak Score on Sedative Subscale of the Adjective Rating ScaleSubjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone 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 2 hours after sampling each methamphetamine dose under both buspirone 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 2 hours after sampling each methamphetamine dose under both buspirone 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 2 hours after sampling each methamphetamine dose under both buspirone 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 2 hours after sampling each methamphetamine dose under both buspirone 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 2 hours after sampling each methamphetamine dose under both buspirone 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 2 hours after sampling each methamphetamine dose under both buspirone 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 2 hours after sampling each methamphetamine dose under both buspirone 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 2 hours after sampling each methamphetamine dose under both buspirone 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 Methamphetamine Doses Self-AdministeredPlaceboPlacebo Methamphetamine1.25Standard Error 1.25Number of Methamphetamine Doses
Number of Methamphetamine Doses Self-AdministeredBuspironePlacebo Methamphetamine0Standard Error 0Number of Methamphetamine Doses
Number of Methamphetamine Doses Self-AdministeredPlacebo10 mg Methamphetamine6.13Standard Error 1.72Number of Methamphetamine Doses
Number of Methamphetamine Doses Self-AdministeredBuspirone10 mg Methamphetamine4Standard Error 1.78Number of Methamphetamine Doses
Number of Methamphetamine Doses Self-AdministeredPlacebo30 mg Methamphetamine7.88Standard Error 1.42Number of Methamphetamine Doses
Number of Methamphetamine Doses Self-AdministeredBuspirone30 mg Methamphetamine7.5Standard Error 1.64Number of Methamphetamine Doses
Peak Score on Sedative Subscale of the Adjective Rating ScalePlaceboPlacebo Methamphetamine3.38Standard Error 1.66units on a scale
Peak Score on Sedative Subscale of the Adjective Rating ScaleBuspironePlacebo Methamphetamine2.75Standard Error 1.42units on a scale
Peak Score on Sedative Subscale of the Adjective Rating ScalePlacebo10 mg Methamphetamine3.63Standard Error 1.08units on a scale
Peak Score on Sedative Subscale of the Adjective Rating ScaleBuspirone10 mg Methamphetamine3.75Standard Error 1.33units on a scale

Participant flow12

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

PeriodMilestoneGroupParticipantsUnits counted
First Treatment (11 Days)STARTEDPlacebo Then Buspirone5
First Treatment (11 Days)STARTEDBuspirone Then Placebo4
First Treatment (11 Days)COMPLETEDPlacebo Then Buspirone4
First Treatment (11 Days)COMPLETEDBuspirone Then Placebo4
First Treatment (11 Days)NOT COMPLETEDPlacebo Then Buspirone1
First Treatment (11 Days)NOT COMPLETEDBuspirone Then Placebo0
Second Treatment (11 Days)STARTEDPlacebo Then Buspirone4
Second Treatment (11 Days)STARTEDBuspirone Then Placebo4
Second Treatment (11 Days)COMPLETEDPlacebo Then Buspirone4
Second Treatment (11 Days)COMPLETEDBuspirone Then Placebo4

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 mortalityPlacebo08
Total, all-cause mortalityBuspirone08
Total, other adverse eventsPlacebo08
Total, other adverse eventsBuspirone08
Total, serious adverse eventsPlacebo08
Total, serious adverse eventsBuspirone08

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
R21DA035481Buspirone as a Candidate Medication for Methamphetamine AbuseRUSH, CRAIG RUNIVERSITY OF KENTUCKYNATIONAL INSTITUTE ON DRUG ABUSE2013 to 2014

Trial comparisons2

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

ComparisonSource
Buspirone vs Placebo: deaths from any causeTrial comparisons
Buspirone vs Placebo: serious adverse eventsTrial comparisons

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/NCT01843205

GET https://conductscience.org/api/trials/v1/NCT01843205/registered?page=2