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Targeting GABA and Opioid Systems for a Pharmacotherapy for Methamphetamine Abuse

This study is currently recruiting participants.
Verified October 2017 by Craig Rush, University of Kentucky
Sponsor:
ClinicalTrials.gov Identifier:
NCT01967381
First Posted: October 22, 2013
Last Update Posted: October 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Craig Rush, University of Kentucky
  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®) Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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 Craig Rush, 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 ]
    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 ]
    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 ]
    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 2018
Estimated Primary Completion Date: September 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute on Drug Abuse (NIDA)
  More Information

Responsible Party: Craig Rush, Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT01967381     History of Changes
Other Study ID Numbers: R01DA033394 ( U.S. NIH Grant/Contract )
First Submitted: October 15, 2013
First Posted: October 22, 2013
Last Update Posted: October 3, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Naltrexone
Methamphetamine
Oxazepam
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Stimulants
Sympathomimetics
Autonomic Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents