Modafinil for Methamphetamine Dependence

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. Identifier: NCT00859573
Recruitment Status : Terminated (Terminated due to lack of funding.)
First Posted : March 11, 2009
Results First Posted : July 15, 2011
Last Update Posted : November 21, 2017
Information provided by (Responsible Party):
University of Arkansas

March 10, 2009
March 11, 2009
April 15, 2011
July 15, 2011
November 21, 2017
April 2009
January 2010   (Final data collection date for primary outcome measure)
Mean Treatment Effectiveness Scores [ Time Frame: thrice weekly from week 3 through week 8 ]
Number of negative drug screens for methamphetamine during the study (every negative drug screen obtained is counted as 1 negative drug screen)divided by the total possible number of drug screens during the 6 week post residential phase of trial(participants provided 3 drug screens per week so the expected number of drug screens total is 18.This does include week 8. Missing drug screens are counted as positive.# negative drug screens/18. Minimum score is 0 and maximum score is 1. The higher the score the better the outcome. The mean of the individual treatment effectiveness scores is reported.
  • urine toxicology screens [ Time Frame: thrice weekly ]
  • Withdrawal Symptoms [ Time Frame: thrice weekly ]
Complete list of historical versions of study NCT00859573 on Archive Site
Not Provided
  • Pre-attentional Neurophysiological Measures [ Time Frame: week 0, week 2, week 10 ]
  • Attentional Neurophysiological Measures [ Time Frame: week 0, 2, 10 ]
  • Vital Signs [ Time Frame: thrice weekly ]
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Modafinil for Methamphetamine Dependence
Clinical Efficacy of Modafinil in Recently-Abstinent Methamphetamine-Dependent Volunteers
Fifty methamphetamine dependent treatment-seeking volunteers will be enrolled in this 10 week, double bind, placebo controlled, randomized clinical trial to receive either modafinil or placebo. Eligible subjects will reside at the Recovery Centers of Arkansas residential facility to achieve initial abstinence and be inducted onto study medication during wks 1-2. Then during wks 3-10, subjects participate on an outpatient basis, receiving weekly psychotherapy while continuing to receive study medications. Urine samples will be collected thrice weekly and self reports weekly to assess methamphetamine use. It is hoped that the results of this study will contribute to our understanding of which types of agents may be good candidates for further development as potential treatment agents for this disorder.
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Methamphetamine Dependence
  • Drug: Modafinil
    400 mg/day
  • Drug: Placebo
    inactive substance
  • Active Comparator: 1. Modafinil
    Intervention: Drug: Modafinil
  • Placebo Comparator: 2: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2010
January 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

18-65 years old. For the neurophysiological measures portion of the study subjects will be included if they are between the ages of 20-65 because the P50 potential is not fully developed in children and adolescents (Rasco 2000).

  • not currently enrolled in a treatment program
  • subjects must have a history of methamphetamine use with recent use confirmed by a positive urine toxicology screen for amphetamines during the month prior to study entry
  • subjects must meet DSM-IV criteria for amphetamine dependence as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV (SCID)
  • women of childbearing age must have a negative pregnancy test to enroll in this study, agree to monthly pregnancy testing, and agree to use appropriate forms of birth control for the duration of the study.

Exclusion Criteria:

  • current diagnosis of alcohol, opiate, or sedative physical dependence
  • ill health (e.g., major cardiovascular, renal, endocrine, hepatic disorder)
  • history of schizophrenia, or bipolar type I disorder
  • present or recent use of over-the-counter or prescription psychoactive drug or drug(s) that would be expected to have major interaction with drug to be tested
  • medical contraindication to receiving study medications (e.g., allergy to modafinil, treatment with cyclosporine, clomipramine or desipramine)
  • current suicidality or psychosis
  • Liver function tests (i.e., liver enzymes) greater than three times normal levels
  • pregnancy or breastfeeding
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
P50 DA018197-104386
Not Provided
Not Provided
University of Arkansas
University of Arkansas
Not Provided
Principal Investigator: Michael Mancino, MD University of Arkansas
University of Arkansas
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP