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Assessment of Interactions Between Intravenous Methamphetamine and Modafinil - 1

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2005 by National Institute on Drug Abuse (NIDA).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00265278
First Posted: December 14, 2005
Last Update Posted: January 11, 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. Read our disclaimer for details.
Information provided by:
National Institute on Drug Abuse (NIDA)
  Purpose
The purpose of this study is to assess the potential interactions between intravenous methamphetamine and oral Modafinil.

Condition Intervention Phase
Amphetamine-Related Disorders Drug: Modafinil Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo-Controlled Assessment of Interactions Between Intravenous Methamphetamine and Modafinil

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Cardiovascular
  • Subjective symptoms/Mood Effects

Estimated Enrollment: 16
Study Start Date: March 2005
Estimated Study Completion Date: March 2006
Detailed Description:
The primary aims of this experiment are to determine if there are significant safety interactions between oral modafinil and intravenous methamphetamine. Safety will be assessed by measuring adverse events and cardiovascular responses of heart rate (HR), blood pressure (BP), and electrocardiogram (ECG) and stroke distance (ICG).
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • normotensive
  • good physical and mental health
  • body mass index between 18 and 30
  • if female, using an acceptable method of contraception and are not pregnant
  • able to give voluntary informed consent

Exclusion Criteria:

  • Please contact site for further details
  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): NCT00265278


Locations
United States, California
U of CA, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Reese Jones, M.D. Langley Porter Psychiatric Institute
  More Information

ClinicalTrials.gov Identifier: NCT00265278     History of Changes
Other Study ID Numbers: NIDA-CPU-0008-1
First Submitted: December 13, 2005
First Posted: December 14, 2005
Last Update Posted: January 11, 2017
Last Verified: December 2005

Additional relevant MeSH terms:
Amphetamine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Modafinil
Armodafinil
Methamphetamine
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors