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Phase 2, Multi-Center Trial of Modafinil for Methamphetamine Dependence

This study has been completed.
Sponsor:
Collaborator:
VA Office of Research and Development
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00520286
First received: August 23, 2007
Last updated: February 23, 2017
Last verified: February 2017
  Purpose
The purpose of this study will be to examine the safety and efficacy of modafinil in increasing number of methamphetamine non-use weeks in subjects with methamphetamine dependence.

Condition Intervention Phase
Methamphetamine Dependence Drug: Modafinil Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase2, Double-blind, Placebo-controlled Trial of Modafinil for the Treatment of Methamphetamine Dependence

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Abstinence (Week 1 - 12) [ Time Frame: Weeks 1 - 12 ]
    Number of participant who abstained from methamphetamine from weeks 1 through 12


Secondary Outcome Measures:
  • Reduction of Craving [ Time Frame: 21 days ]
    Number of subjects with 21 or more consecutive days of abstinence


Enrollment: 210
Study Start Date: December 2007
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Modafinil
Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks
Drug: Modafinil
200 mg or 400 mg /daily
Placebo Comparator: Placebo
Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks
Drug: Placebo
Placebo / daily

Detailed Description:
To evaluate the efficacy and safety of modafinil in reducing methamphetamine use in subjects with methamphetamine dependence. It is hypothesized that modafinil, compared to placebo, will be associated with an increase in the number of methamphetamine non-use weeks over time as measured by quantitative urine analysis for methamphetamine.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be between the ages of 18 and 65
  • Methamphetamine dependent as defined by DSM-IV criteria
  • Must be in good general heath with a history of methamphetamine use at screening
  • Must be able to provide written informed consent
  • If female and of child bearing potential, must agree to use birth control.

Exclusion Criteria:

  • Please contact site for more information
  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: NCT00520286

Locations
United States, California
South Bay Treatment Center
San Diego, California, United States, 92105
Matrix Institute on Addictions
Tarzana, California, United States, 91356
Torrance Site
Torrance, California, United States, 90502
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80220
United States, Hawaii
John A. Burns School of Medicine
Honolulu, Hawaii, United States, 96813
United States, Iowa
Powell Chemical Dependency Center
Des Moines, Iowa, United States, 50316
United States, Missouri
START Research and Treatment
Kansas City, Missouri, United States, 64131
United States, Utah
Salt Lake City VA Medical Center
Salt Lake City, Utah, United States, 84148
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
VA Office of Research and Development
Investigators
Principal Investigator: Ahmed Elkashef, M.D. National Institute on Drug Abuse (NIDA)
  More Information

Publications:
Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00520286     History of Changes
Other Study ID Numbers: NIDA-CSP-1026-1
Study First Received: August 23, 2007
Results First Received: December 30, 2016
Last Updated: February 23, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by National Institute on Drug Abuse (NIDA):
Methamphetamine Dependence

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on August 18, 2017