Impact of Buspirone Maintenance on the Reinforcing Effects of Cocaine

This study is currently recruiting participants.
Verified July 2013 by University of Kentucky
Sponsor:
Collaborator:
Information provided by (Responsible Party):
William Stoops, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01639157
First received: July 10, 2012
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

Cocaine use disorders are an unrelenting public health concern. Intensive research efforts have yielded behavioral interventions that reduce cocaine 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 cocaine and alternative reinforcers. These preliminary data will be used to support further research developing buspirone as a pharmacotherapy for cocaine use disorders. We hypothesize that buspirone will attenuate the reinforcing effects of cocaine and increase the reinforcing effects of alternative reinforcers.


Condition Intervention
Cocaine Use Disorders
Drug: Buspirone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Human Laboratory Study of the Impact of Buspirone Maintenance on the Reinforcing, Subjective and Performance Effects of Cocaine

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Reinforcing Effects [ Time Frame: 6 Times over Approximately 2 Week Inpatient Admission ] [ Designated as safety issue: No ]
    The reinforcing effects of cocaine will be determined using a modified progressive ratio procedure (Stoops et al., 2010) in which subjects choose between available cocaine doses and money. Reinforcing effects are measured during both buspirone and placebo maintenance.


Secondary Outcome Measures:
  • Subjective Effects [ Time Frame: During 6 sessions over approximately 2 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 2 week inpatient admission ] [ Designated as safety issue: Yes ]
    Physiological and side effects measures will be completed daily while they 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.

  • Performance Effects [ Time Frame: During 6 sessions over approximately 2 week inpatient admission ] [ Designated as safety issue: No ]
    Subjects will complete a performance measure (i.e., the digit symbol substitution task) during six sessions while they are admitted to our inpatient unit.


Estimated Enrollment: 16
Study Start Date: September 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Buspirone
Subjects will be maintained on buspirone.
Drug: Buspirone
Subjects will be maintained on oral buspirone (administered 3 times daily) or placebo for 6 days each during the study in random order.
Placebo Comparator: Placebo
Subjects will be maintained on placebo.
Drug: Buspirone
Subjects will be maintained on oral buspirone (administered 3 times daily) or placebo for 6 days each during the study in random order.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Recent cocaine 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 cocaine or buspirone
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01639157

Contacts
Contact: William W Stoops, Ph.D. 859-257-5388 william.stoops@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: William W Stoops, Ph.D.         
Sponsors and Collaborators
William Stoops
Investigators
Principal Investigator: William W Stoops, Ph.D. University of Kentucky
  More Information

Publications:
Responsible Party: William Stoops, Assistant Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT01639157     History of Changes
Other Study ID Numbers: R21DA034095-01
Study First Received: July 10, 2012
Last Updated: July 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders
Buspirone
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 23, 2014