Clinical Trials/NCT01843205

NCT01843205

Completed

Phase 1

Buspirone as a Candidate Medication for Methamphetamine Abuse

University of Kentucky1 site in 1 country9 target enrollmentApril 2013

ConditionsMethamphetamine Dependence Methamphetamine Abuse

InterventionsMethamphetamine Placebo

DrugsMethamphetamine Placebo

Overview

Phase: Phase 1
Intervention: Methamphetamine
Conditions: Methamphetamine Dependence
Sponsor: University of Kentucky
Enrollment: 9
Locations: 1
Primary Endpoint: Number of Methamphetamine Doses Self-Administered
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2013

End Date

March 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

University of Kentucky

Responsible Party

Principal Investigator

Craig Rush

Professor

University of Kentucky

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

Arms & Interventions

Placebo

Subjects will be maintained on placebo.

Intervention: Methamphetamine

Placebo

Subjects will be maintained on placebo.

Intervention: Placebo

Buspirone

Subjects will be maintained on buspirone.

Intervention: Methamphetamine

Buspirone

Subjects will be maintained on buspirone.

Intervention: Placebo

Outcomes

Primary Outcomes

Number of Methamphetamine Doses Self-Administered

Time Frame: 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 Outcomes

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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
Peak Ratings of "Like Drug" 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.)
Peak Ratings of "Nauseous" 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.)
Peak Ratings of "Nervous/Anxious" 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.)
Peak Ratings of "Willing to Pay For" 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.)
Peak Ratings of "Performance Impaired" 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.)
Peak Ratings of "Performance Improved" 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.)
Peak Ratings of "Restless" 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.)
Peak Ratings of "Rush" 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.)
Peak Ratings of "Shaky/Jittery" 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.)
Peak Ratings of "Stimulated" 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.)
Peak Ratings of "Willing to Take Again" 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.)
Peak Ratings of "Talkative/Friendly" 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.)
Peak Diastolic Blood Pressure(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
Peak Systolic Blood Pressure(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
Peak Heart Rate(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)
Peak Ratings of "Sluggish/Fatigued/Lazy" 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.)
Peak Temperature(Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.)