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Buspirone as a Candidate Medication for Methamphetamine Abuse

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University of Kentucky

Status and phase

Completed
Phase 1

Conditions

Methamphetamine Dependence
Methamphetamine Abuse

Treatments

Drug: Methamphetamine
Drug: Placebo

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01843205
R21DA035481 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

9 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Subjects will be maintained on placebo.
Treatment:
Drug: Placebo
Drug: Methamphetamine
Buspirone
Experimental group
Description:
Subjects will be maintained on buspirone.
Treatment:
Drug: Placebo
Drug: Methamphetamine

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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