Methamphetamine-Quetiapine Interactions in Humans

This study has been terminated.
(Study was terminated due to insufficient funds)
Sponsor:
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00567866
First received: December 3, 2007
Last updated: July 12, 2010
Last verified: July 2010
  Purpose

This study will test the ability of a medicine (Quetiapine) that is used to treat schizophrenia or bipolar disorder to reduce the effects of methamphetamine that make it difficult for users to stop using it. This study will test the ability of a medicine that is used to treat schizophrenia or bipolar disorder to reduce the effects of methamphetamine that make it difficult for users to stop using it. The investigator thinks quetiapine will lessen the effects of methamphetamine.


Condition Intervention Phase
Methamphetamine Dependence
Drug: Quetiapine
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Methamphetamine-Quetiapine Interaction in Humans: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Behavioral Responses to Methamphetamine following predosing with placebo or test article. [ Time Frame: Prior to drug administration, and 10 minutes post-drug administration and then hourly for 9 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Physiological Responses to methamphetamine following predosing of placebo or test article [ Time Frame: Pre-drug dosing, 5, 20, 35, and 50 minutes postdosing until 4 hours postodose, and then twice hourly until the seventh hour ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: January 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
placebo -50 mg quetiapine- 100 mg quetiapine
Drug: Quetiapine
50 or 100 mg of quetiapine orally
Experimental: 2
50 mg quetiapine -100 mg quetiapine- placebo
Drug: Quetiapine
50 or 100 mg of quetiapine orally
Experimental: 3
50 mg quetiapine -placebo- 100 mg quetiapine
Drug: Quetiapine
50 or 100 mg of quetiapine orally

Detailed Description:

The specific goal of this project is to examine whether quetiapine will alter the behavioral effects of methamphetamine without producing major cardiovascular changes or toxic effects under controlled laboratory conditions. This goal will be accomplished using a methamphetamine challenge procedure in which quetiapine will be given orally prior to intravenous (iv) methamphetamine administration. This will allow rapid and systematic evaluation of the therapeutic potential of this medication.

Results of this drug-interaction study will help determine further investigations of the clinical efficacy of this and other dopamine-active agents. We hypothesize that quetiapine will reduce the self-reported, performance and cardiovascular effects of methamphetamine.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must be between the ages of 18-50.
  2. Must have experience with IV methamphetamine use, with self-reported recent history of weekly use being greater than the total administered in the study. Recent use will be confirmed by a urine toxicology screen positive for amphetamines. We will recruit moderate to frequent users of methamphetamine. Moderate use is defined as use from once or twice every six weeks to weekly. Frequent users are defined as individuals who use greater than weekly.
  3. Must have recent use confirmed by a urine toxicology screen positive for amphetamines.
  4. Must not be seeking treatment for methamphetamine abuse/dependence.

Exclusion Criteria:

  1. Ill health (major cardiovascular, renal, endocrine, hepatic disorder).
  2. Current diagnosis of other drug or alcohol physical dependence (other than nicotine or caffeine).
  3. History of major organic psychiatric disorder (psychosis, schizophrenia, bipolar, mania) or significant psychiatric symptoms at the time of evaluation for study participation, including suicidal ideation.
  4. Pregnancy, plans to become pregnant or fertile women without adequate means of contraception.
  5. Present or recent use of over-the-counter or prescription psychoactive drug or drugs that would have major interaction with drugs to be tested.
  6. Medical contraindication to or prior serious adverse effects from methamphetamine or stimulants (i.e., seizures, cardiac arrest) or medical contraindication to test agents (see risks section). Significant physical or psychiatric illness which might impair the ability to safely complete the study or that might be complicated by the study drugs, including prior seizures (after age 8) or other active neurological disease or clinically significant abnormalities on physical examination or screening laboratory values.
  7. Current enrollment in a methamphetamine, alcohol, or other drug treatment program or current legal problems relating to methamphetamine, alcohol, or other drug use, including awaiting trial or supervision by a parole or probation officer
  8. Body Mass Index >30 or <18
  9. Currently trying to quit methamphetamine use or seeking treatment for methamphetamine use
  10. History of serious adverse event or hypersensitivity to methamphetamine or other study drugs
  11. Currently taking any medication (including highly active antiretroviral therapy (HAART) for HIV) other than over-the-counter nonsteroidal anti-inflammatory medications, topical medications, inhaled asthma therapy, and over-the-counter nonsedating antihistamines
  12. Use within the last month of the Vicks Nasal Inhaler or medications that are metabolized to methamphetamine (e.g. selegiline)

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567866

Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: William Brooks Gentry, MD University of Arkansas
  More Information

No publications provided

Responsible Party: Carole Hamon, University of Arkansas for Medical Sciences
ClinicalTrials.gov Identifier: NCT00567866     History of Changes
Other Study ID Numbers: 72900
Study First Received: December 3, 2007
Last Updated: July 12, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Methamphetamine
Quetiapine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 15, 2014