Buspirone as a Candidate Medication for Methamphetamine Abuse

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2017-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Methamphetamine Dependence Methamphetamine Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Placebo

Subjects will be maintained on placebo.

Group Type PLACEBO_COMPARATOR

Methamphetamine

Intervention Type DRUG

The pharmacodynamic effects of methamphetamine will be determined during placebo and buspirone maintenance.

Placebo

Intervention Type DRUG

The pharmacodynamic effects of placebo methamphetamine will be determined during placebo and buspirone maintenance.

Buspirone

Subjects will be maintained on buspirone.

Group Type EXPERIMENTAL

Methamphetamine

Intervention Type DRUG

The pharmacodynamic effects of methamphetamine will be determined during placebo and buspirone maintenance.

Placebo

Intervention Type DRUG

The pharmacodynamic effects of placebo methamphetamine will be determined during placebo and buspirone maintenance.

Interventions

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Methamphetamine

The pharmacodynamic effects of methamphetamine will be determined during placebo and buspirone maintenance.

Intervention Type DRUG

Placebo

The pharmacodynamic effects of placebo methamphetamine will be determined during placebo and buspirone maintenance.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes