Buspirone as a Candidate Medication for Methamphetamine Abuse

NCT01843205 | Completed Phase 1 Results

• 1 other identifier: R21DA035481
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Methamphetamine Dependence; Methamphetamine Abuse

Outcome Measures

Primary Outcomes (1)

• Number of Methamphetamine Doses Self-Administered

  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.

  One test per methamphetamine dose level per intervention for each participant over his/her approximate 25 day inpatient admission

Secondary Outcomes (26)

• 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.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects will be maintained on placebo.

Drug: Methamphetamine; Drug: Placebo

Buspirone

EXPERIMENTAL

Subjects will be maintained on buspirone.

Drug: Methamphetamine; Drug: Placebo

Interventions

Methamphetamine DRUG

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

Buspirone; Placebo

Placebo DRUG

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

Buspirone; Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Lifetime methamphetamine use

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kentucky: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Interventions

Methamphetamine

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Craig R. Rush, Ph.D.
• Organization: University of Kentucky

crush2@email.uky.edu

(859) 257-5388

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 22, 2013
• First Posted: April 30, 2013
• Study Start: April 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: February 7, 2018
• Results First Posted: February 7, 2018

Record last verified: 2018-01

Locations

US (1)