Trial · NCT01843205
Buspirone as a Candidate Medication for Methamphetamine Abuse
NCT01843205, Phase 1, Completed, University of Kentucky; results first posted 2018-02-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Methamphetamine Doses Self-Administered | One 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. |
| Secondary | Peak Score on Sedative Subscale of the Adjective Rating Scale | Subjects 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. |
| Secondary | Peak Score on Stimulant Subscale of the Adjective Rating Scale | Subjects 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. |
| Secondary | Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale | Subjects 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. |
| Secondary | Peak Ratings of "Any Effect" on the Visual Analog Scale | Subjects 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. |
| Secondary | Peak Ratings of "Bad Effects" on the Visual Analog Scale | Subjects 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. |
| Secondary | Peak Ratings of "Euphoric" on the Visual Analog Scale | Subjects 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. |
| Secondary | Peak Ratings of "Good Effects" on the Visual Analog Scale | Subjects 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. |
| Secondary | Peak Ratings of "High" on the Visual Analog Scale | Subjects 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. |
| Secondary | Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale | Subjects 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. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Methamphetamine Doses Self-Administered | One test per methamphetamine dose level per intervention for each participant over his/her approximate 25 day inpatient admission | Number of Methamphetamine Doses | MEAN | |
| SECONDARY | Peak Score on Sedative Subscale of the Adjective Rating Scale | Subjects 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 scale | MEAN | |
| SECONDARY | Peak Score on Stimulant Subscale of the Adjective Rating Scale | Subjects 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 scale | MEAN | |
| SECONDARY | Peak Ratings of Active, Alert, Energetic on the Visual Analog Scale | Subjects 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 scale | MEAN | |
| SECONDARY | Peak Ratings of Any Effect on the Visual Analog Scale | Subjects 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 scale | MEAN | |
| SECONDARY | Peak Ratings of Bad Effects on the Visual Analog Scale | Subjects 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 scale | MEAN | |
| SECONDARY | Peak Ratings of Euphoric on the Visual Analog Scale | Subjects 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 scale | MEAN | |
| SECONDARY | Peak Ratings of Good Effects on the Visual Analog Scale | Subjects 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 scale | MEAN | |
| SECONDARY | Peak Ratings of High on the Visual Analog Scale | Subjects 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 scale | MEAN | |
| SECONDARY | Peak Ratings of Irregular/Racing Heartbeat on the Visual Analog Scale | Subjects 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 scale | MEAN |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group162
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Methamphetamine Doses Self-Administered | Placebo | Placebo Methamphetamine | 1.25 | Standard Error 1.25 | Number of Methamphetamine Doses |
| Number of Methamphetamine Doses Self-Administered | Buspirone | Placebo Methamphetamine | 0 | Standard Error 0 | Number of Methamphetamine Doses |
| Number of Methamphetamine Doses Self-Administered | Placebo | 10 mg Methamphetamine | 6.13 | Standard Error 1.72 | Number of Methamphetamine Doses |
| Number of Methamphetamine Doses Self-Administered | Buspirone | 10 mg Methamphetamine | 4 | Standard Error 1.78 | Number of Methamphetamine Doses |
| Number of Methamphetamine Doses Self-Administered | Placebo | 30 mg Methamphetamine | 7.88 | Standard Error 1.42 | Number of Methamphetamine Doses |
| Number of Methamphetamine Doses Self-Administered | Buspirone | 30 mg Methamphetamine | 7.5 | Standard Error 1.64 | Number of Methamphetamine Doses |
| Peak Score on Sedative Subscale of the Adjective Rating Scale | Placebo | Placebo Methamphetamine | 3.38 | Standard Error 1.66 | units on a scale |
| Peak Score on Sedative Subscale of the Adjective Rating Scale | Buspirone | Placebo Methamphetamine | 2.75 | Standard Error 1.42 | units on a scale |
| Peak Score on Sedative Subscale of the Adjective Rating Scale | Placebo | 10 mg Methamphetamine | 3.63 | Standard Error 1.08 | units on a scale |
| Peak Score on Sedative Subscale of the Adjective Rating Scale | Buspirone | 10 mg Methamphetamine | 3.75 | Standard Error 1.33 | units on a scale |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Treatment (11 Days) | STARTED | Placebo Then Buspirone | 5 | |
| First Treatment (11 Days) | STARTED | Buspirone Then Placebo | 4 | |
| First Treatment (11 Days) | COMPLETED | Placebo Then Buspirone | 4 | |
| First Treatment (11 Days) | COMPLETED | Buspirone Then Placebo | 4 | |
| First Treatment (11 Days) | NOT COMPLETED | Placebo Then Buspirone | 1 | |
| First Treatment (11 Days) | NOT COMPLETED | Buspirone Then Placebo | 0 | |
| Second Treatment (11 Days) | STARTED | Placebo Then Buspirone | 4 | |
| Second Treatment (11 Days) | STARTED | Buspirone Then Placebo | 4 | |
| Second Treatment (11 Days) | COMPLETED | Placebo Then Buspirone | 4 | |
| Second Treatment (11 Days) | COMPLETED | Buspirone Then Placebo | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse 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.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 8 |
| Total, all-cause mortality | Buspirone | 0 | 8 |
| Total, other adverse events | Placebo | 0 | 8 |
| Total, other adverse events | Buspirone | 0 | 8 |
| Total, serious adverse events | Placebo | 0 | 8 |
| Total, serious adverse events | Buspirone | 0 | 8 |
Source ClinicalTrials.gov
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21DA035481 | Buspirone as a Candidate Medication for Methamphetamine Abuse | RUSH, CRAIG R | UNIVERSITY OF KENTUCKY | NATIONAL INSTITUTE ON DRUG ABUSE | 2013 to 2014 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Buspirone vs Placebo: deaths from any cause | Trial comparisons |
| Buspirone vs Placebo: serious adverse events | Trial 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.
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