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Buspirone as a Candidate Medication for Methamphetamine Abuse

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Kentucky
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Craig Rush, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01843205
First received: April 22, 2013
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Methamphetamine Dependence
Methamphetamine Abuse
Drug: Methamphetamine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Buspirone as a Candidate Medication for Methamphetamine Abuse

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Reinforcing Effects of Methamphetamine During Buspirone Treatment [ Time Frame: After at least 6 days of buspirone maintenance ] [ Designated as safety issue: No ]
    The reinforcing effects of methamphetamine will be determined during 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.

  • Reinforcing Effects of Methamphetamine During Placebo Treatment [ Time Frame: After at least 6 days of placebo maintenance ] [ Designated as safety issue: No ]
    The reinforcing effects of methamphetamine will be determined during placebo 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 Outcome Measures:
  • Subjective Effects [ Time Frame: 6 sessions over approximately 3 week inpatient admissions ] [ Designated as safety issue: Yes ]
    Subjects will complete subjective effects measures during six sessions while they are admitted to our inpatient unit. These items will ask about drug effects and general mood.

  • Physiological and Side Effects [ Time Frame: Daily over approximately 3 week inpatient admission ] [ Designated as safety issue: Yes ]
    Physiological and side effects measures will be completed daily while subjects are admitted to our inpatient unit. Physiological measures include heart rate and blood pressure. Side Effects questions will query subjects about common effects of centrally active medications.


Estimated Enrollment: 12
Study Start Date: April 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Subjects will be maintained on placebo.
Drug: Methamphetamine
The pharmacodynamic effects of methamphetamine will be determined during placebo and buspirone maintenance.
Experimental: Buspirone
Subjects will be maintained on buspirone.
Drug: Methamphetamine
The pharmacodynamic effects of methamphetamine will be determined during placebo and buspirone maintenance.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01843205

Contacts
Contact: Craig R Rush, Ph.D. 859-257-5388 crush2@email.uky.edu

Locations
United States, Kentucky
University of Kentucky Medical Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: William W Stoops, Ph.D.    859-257-5388    william.stoops@uky.edu   
Principal Investigator: Craig R Rush, Ph.D.         
Sponsors and Collaborators
University of Kentucky
  More Information

No publications provided

Responsible Party: Craig Rush, Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT01843205     History of Changes
Other Study ID Numbers: R21DA035481, R21DA035481
Study First Received: April 22, 2013
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Buspirone
Methamphetamine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Anti-Anxiety Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Receptor Agonists
Sympathomimetics
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014