Clinical trial NCT01843205: Buspirone as a Candidate Medication for Methamphetamine Abuse
Official title: Buspirone as a Candidate Medication for Methamphetamine Abuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Methamphetamine Dependence
Methamphetamine Abuse
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-04-30
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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

Primary outcomes:
measure: Number of Methamphetamine Doses Self-Administered
timeFrame: One test per methamphetamine dose level per intervention for each participant over his/her approximate 25 day inpatient admission
Secondary outcomes:
measure: Peak Score on Sedative Subscale of the Adjective Rating Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.
measure: Peak Score on Stimulant Subscale of the Adjective Rating Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.
measure: Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.
measure: Peak Ratings of "Any Effect" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.
measure: Peak Ratings of "Bad Effects" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.
measure: Peak Ratings of "Euphoric" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.
measure: Peak Ratings of "Good Effects" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.
measure: Peak Ratings of "High" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.
measure: Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.
measure: Peak Ratings of "Like Drug" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.
measure: Peak Ratings of "Nauseous" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.
measure: Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.
measure: Peak Ratings of "Willing to Pay For" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.
measure: Peak Ratings of "Performance Impaired" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.
measure: Peak Ratings of "Performance Improved" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.
measure: Peak Ratings of "Restless" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.
measure: Peak Ratings of "Rush" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.
measure: Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.
measure: Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.
measure: Peak Ratings of "Stimulated" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.
measure: Peak Ratings of "Willing to Take Again" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.
measure: Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.
measure: Peak Diastolic Blood Pressure
timeFrame: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.
measure: Peak Systolic Blood Pressure
timeFrame: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.
measure: Peak Heart Rate
timeFrame: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.
measure: Peak Temperature
timeFrame: Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
Study officials:
References: