Phase 1
N=9
Buspirone as a Candidate Medication for Methamphetamine Abuse
Methamphetamine Dependence · Methamphetamine Abuse
Bottom Line
View on ClinicalTrials.gov: NCT01843205 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Number of Methamphetamine Doses Self-Administered — 1.25; 0; 6.13; 4 Number of Methamphetamine Doses
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Methamphetamine (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Kentucky
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Methamphetamine Doses Self-Administered |
1.25; 0; 6.13; 4; 7.88; 7.5 | — |
| SECONDARY Peak Score on Sedative Subscale of the Adjective Rating Scale |
3.38; 2.75; 3.63; 3.75; 3; 3.25 | — |
| SECONDARY Peak Score on Stimulant Subscale of the Adjective Rating Scale |
5.63; 7.25; 9.88; 9.25; 11.38; 13 | — |
| SECONDARY Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale |
2.13; 8.75; 19; 14.5; 35; 29.25 | — |
| SECONDARY Peak Ratings of "Any Effect" on the Visual Analog Scale |
0.75; 10; 25.75; 21.5; 34.38; 33 | — |
| SECONDARY Peak Ratings of "Bad Effects" on the Visual Analog Scale |
0.13; 1.5; 7; 7.63; 3.13; 8.38 | — |
| SECONDARY Peak Ratings of "Euphoric" on the Visual Analog Scale |
0.63; 0; 4.88; 3.88; 7.63; 8.5 | — |
| SECONDARY Peak Ratings of "Good Effects" on the Visual Analog Scale |
0.88; 9.63; 21; 17.38; 30.63; 31.5 | — |
| SECONDARY Peak Ratings of "High" on the Visual Analog Scale |
0.63; 10.5; 22.13; 16.5; 28.63; 31 | — |
| SECONDARY Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale |
0.75; 8.5; 10.63; 10.75; 14.38; 16.13 | — |
| SECONDARY Peak Ratings of "Like Drug" on the Visual Analog Scale |
0.63; 9.63; 22.63; 18.50; 32.75; 30.50 | — |
| SECONDARY Peak Ratings of "Nauseous" on the Visual Analog Scale |
0; 0; 6.38; 2.38; 3.50; 5 | — |
| SECONDARY Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale |
0.88; 0; 2.38; 1; 4; 3.75 | — |
| SECONDARY Peak Ratings of "Willing to Pay For" on the Visual Analog Scale |
1.63; 9.38; 19.88; 17.75; 34.00; 31.63 | — |
| SECONDARY Peak Ratings of "Performance Impaired" on the Visual Analog Scale |
0.25; 0; 2.13; 0; 0; 1.38 | — |
| SECONDARY Peak Ratings of "Performance Improved" on the Visual Analog Scale |
0; 9.25; 15; 13.38; 19.13; 22.75 | — |
| SECONDARY Peak Ratings of "Restless" on the Visual Analog Scale |
5; 0; 3.13; 0.50; 0.25; 1.13 | — |
| SECONDARY Peak Ratings of "Rush" on the Visual Analog Scale |
0.13; 10.25; 21.63; 16.50; 21.75; 26.13 | — |
| SECONDARY Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale |
0.13; 8.38; 1.88; 0.75; 2.88; 5.50 | — |
| SECONDARY Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale |
1.5; 0; 1.88; 2.88; 3.13; 2.25 | — |
| SECONDARY Peak Ratings of "Stimulated" on the Visual Analog Scale |
1.25; 9.88; 21.88; 17.88; 21.50; 24.25 | — |
| SECONDARY Peak Ratings of "Willing to Take Again" on the Visual Analog Scale |
1.25; 9.62; 22.00; 20.63; 35.00; 33.00 | — |
| SECONDARY Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale |
0; 9.25; 18.50; 13.75; 26.00; 27.25 | — |
| SECONDARY Peak Diastolic Blood Pressure |
77.50; 80.13; 80.75; 83.00; 83.80; 84.50 | — |
| SECONDARY Peak Systolic Blood Pressure |
125.38; 125.00; 131.25; 131.63; 139.63; 137.13 | — |
| SECONDARY Peak Heart Rate |
82.75; 81.25; 86.13; 85.13; 85.38; 90.63 | — |
| SECONDARY Peak Temperature |
98.48; 98.41; 98.44; 98.46; 98.33; 98.43 | — |
Summary
Methamphetamine use disorders are an unrelenting public health concern. Intensive research efforts have yielded behavioral interventions that reduce methamphetamine use, however, these interventions are not universally effective and treatment effects diminish over time. Development of a pharmacotherapy that enhances the efficacy of these interventions is a priority for the National Institute on Drug Abuse. This study proposes to determine the impact of buspirone maintenance on self-administration of methamphetamine. These preliminary data will be used to support further research developing buspirone as a pharmacotherapy for methamphetamine use disorders. The investigators hypothesize that buspirone will attenuate the reinforcing effects of methamphetamine.
Eligibility Criteria
Inclusion Criteria
- Lifetime methamphetamine use
Exclusion Criteria
- Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
- Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
- History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
- Females not currently using effective birth control
- Contraindications to methamphetamine or buspirone
Data sourced from ClinicalTrials.gov (NCT01843205). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.