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Targeting GABA and Opioid Systems for a Pharmacotherapy 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:
NCT01967381
First received: October 15, 2013
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

The research proposed in this application will determine the initial efficacy, safety and tolerability of a novel drug combination, oxazepam (Serax®) and naltrexone (Revia®), as a pharmacotherapy for methamphetamine (Desoxyn®) dependence. A rigorous, inpatient human laboratory study will be conducted. The proposed study is innovative and important because it will provide the impetus for the conduct of double blind, placebo-controlled trials to further demonstrate the efficacy of combined oxazepam and naltrexone for managing methamphetamine dependence.


Condition Intervention Phase
Methamphetamine Abuse
Methamphetamine Dependence
Drug: Methamphetamine (Desoxyn®)
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Targeting GABA and Opioid Systems for a Pharmacotherapy for Methamphetamine Abuse

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Reinforcing Effects [ Time Frame: After at least four days of placebo, oxazepam (Serax®), naltrexone (Revia®) or oxazepam and naltrexone maintenance ] [ Designated as safety issue: No ]
    The reinforcing effects of methamphetamine will be determined using a self-administration procedure in which subjects choose to take previously sampled doses. Reinforcing effects are measured during maintenance on placebo, oxazepam (Serax®), naltrexone (Revia®), and oxazepam and naltrexone combined.


Secondary Outcome Measures:
  • Subjective Effects [ Time Frame: 12 sessions over approximately 4 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 4 week inpatient admissions ] [ 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: 28
Study Start Date: October 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm 1
Subjects will be maintained on oral placebo.
Drug: Methamphetamine (Desoxyn®)
The pharmacodynamic effects of methamphetamine (Desoxyn®) will be determined during placebo, oxazepam (Serax®), naltrexone (Revia®) and combined oxazepam and naltrexone maintenance.
Experimental: Arm 2
Subjects will be maintained on oral oxazepam (Serax®).
Drug: Methamphetamine (Desoxyn®)
The pharmacodynamic effects of methamphetamine (Desoxyn®) will be determined during placebo, oxazepam (Serax®), naltrexone (Revia®) and combined oxazepam and naltrexone maintenance.
Experimental: Arm 3
Subjects will be maintained on oral naltrexone (Revia®).
Drug: Methamphetamine (Desoxyn®)
The pharmacodynamic effects of methamphetamine (Desoxyn®) will be determined during placebo, oxazepam (Serax®), naltrexone (Revia®) and combined oxazepam and naltrexone maintenance.
Experimental: Arm 4
Subjects will be maintained on oral naltrexone (Revia®) and oral oxazepam (Serax®).
Drug: Methamphetamine (Desoxyn®)
The pharmacodynamic effects of methamphetamine (Desoxyn®) will be determined during placebo, oxazepam (Serax®), naltrexone (Revia®) and combined oxazepam and naltrexone 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 (Desoxyn®), oxazepam (Serax®) or naltrexone (Revia®)
  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: NCT01967381

Contacts
Contact: William W Stoops, Ph.D. 8592575388 william.stoops@uky.edu

Locations
United States, Kentucky
University of Kentucky Medical Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Craig R Rush, Ph.D.    859-257-5388    crush2@email.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: NCT01967381     History of Changes
Other Study ID Numbers: R01DA033394
Study First Received: October 15, 2013
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration
United States: National Institute on Drug Abuse
United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Additional relevant MeSH terms:
Methamphetamine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Autonomic Agents
Central Nervous System Agents
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
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014