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Effects of Modafinil in 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.
 
ClinicalTrials.gov Identifier: NCT00751023
Recruitment Status : Completed
First Posted : September 11, 2008
Results First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE September 10, 2008
First Posted Date  ICMJE September 11, 2008
Results First Submitted Date  ICMJE November 29, 2018
Results First Posted Date  ICMJE June 13, 2019
Last Update Posted Date June 13, 2019
Study Start Date  ICMJE February 2009
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
Percentage of Participants With Methamphetamine-positive Urine Drug Screens [ Time Frame: 5 weeks ]
Percentage of participants with at least one biweekly urine drug screen positive for methamphetamine (4 weeks active treatment phase + medication-free safety visit at week 5)
Original Primary Outcome Measures  ICMJE
 (submitted: September 10, 2008)
Percentage of methamphetamine-positive urine drug screens [ Time Frame: 5 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • Percent Change in California Verbal Learning Test From Baseline to Study Endpoint [ Time Frame: Study baseline to study endpoint (Week 5) ]
    Mean percent change in T scores (average total score of 6 trials) from baseline to study endpoint (Week 5) in study completers. Larger (more positive) percent change values indicate better outcomes.
  • Percent Change in Symbol Digit Modalities Test From Baseline to Study Endpoint [ Time Frame: 5 Weeks ]
    Mean percent change in T scores from baseline to study endpoint (Week 5) in study completers. Larger (more positive) percent change values indicate better outcomes.
  • Percent Change in Paced Auditory Serial Addition Test Scores From Baseline to Study Endpoint [ Time Frame: 5 weeks ]
    Mean percent change of T scores from baseline to study endpoint (Week 5) in study completers. Min T score = 0, max T score = 100. Higher scores, greater (more positive) percent change indicate better outcomes.
  • Score on the Wisconsin Card Sort Test [ Time Frame: 5 weeks ]
    Scores (T scores) on the Wisconsin Card Sort Test (total errors) at study endpoint (Week 5) in study completers, adjusted for age and education; min=0, max=100, higher numbers indicate better outcomes.
  • Percent Change in the Grooved Pegboard Test Score From Baseline to Study Endpoint [ Time Frame: 5 weeks ]
    Percent change of T scores from baseline to study endpoint (Week 5) in study completers; T score min=0, max=100; higher scores (more positive change) indicate better outcome.
  • Percent Change in Shipley Institute of Living Scale Scores From Baseline to Study Endpoint [ Time Frame: 5 weeks ]
    Percent change in scores (T scores) on the Shipley Abstract subscale from baseline to study endpoint (Week 5) in study completers; T scores min=0, max=100; larger positive values indicate better outcome.
  • Percentage Change in Beck Depression Inventory Scores [ Time Frame: 5 weeks ]
    Percent change in BDI score from baseline to study endpoint in study completers; range =-100% to 100%, larger (more negative) change indicates better outcome.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2008)
  • Score on the California Verbal Learning Test [ Time Frame: 5 weeks ]
  • Score on the Symbol Digit Modalities Test [ Time Frame: 5 weeks ]
  • Score on the Paced Auditory Serial Addition Test [ Time Frame: 5 weeks ]
  • Score on the Wisconsin Card Sort Test [ Time Frame: 5 weeks ]
  • Score on the Grooved Pegboard Test [ Time Frame: 5 weeks ]
  • Score on the Shipley Institute of Living Scale [ Time Frame: 5 weeks ]
  • Score on the Beck Depression Inventory [ Time Frame: 5 weeks ]
  • Effects on cue-induced craving for methamphetamine [ Time Frame: 5 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Modafinil in Methamphetamine Dependence
Official Title  ICMJE Effects of Modafinil in Methamphetamine Dependence
Brief Summary Methamphetamine dependence is a serious public health problem with no pharmacologic treatments currently available. Relapse rates are high in this population. Exposure to cues previously associated with methamphetamine use may induce profound craving in abstinent individuals. Chronic methamphetamine abuse is associated with selective cognitive deficits that may undermine successful participation in psychosocial treatments. Medications which improve cognitive deficits in methamphetamine-dependent individuals may improve abstinence rates, especially in the critical early period of recovery. Modafinil is an atypical stimulant medication with evidence to support its use in treating cocaine dependence and attention deficit/hyperactivity disorder. The proposed studies are designed to evaluate modafinil as a potential treatment for methamphetamine dependence and its cognitive sequelae.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Methamphetamine Dependence
Intervention  ICMJE
  • Drug: Modafinil
    400 mg daily for four weeks
    Other Name: Provigil
  • Drug: Placebo
    Placebo 2 tablets daily for 4 weeks
Study Arms  ICMJE
  • Experimental: 1
    Modafinil 400 mg daily
    Intervention: Drug: Modafinil
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 23, 2019)
40
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2008)
60
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
  2. Subjects must meet DSM-IV criteria for methamphetamine dependence within the past six months. Subjects may meet criteria for abuse, but not dependence on any other substance with the exception of nicotine. Because of the high comorbidity of methamphetamine and nicotine dependence, excluding nicotine dependence would seriously compromise the feasibility of recruitment. Nicotine use immediately prior to the cue reactivity testing session will be controlled.
  3. Subjects must consent to remain abstinent from all drugs of abuse (except nicotine) for 24 hours prior to the cue reactivity testing sessions.
  4. Subjects must consent to random assignment to the modafinil vs. placebo conditions.

Exclusion Criteria:

  1. Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
  2. Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease as these conditions may affect heart rate or skin conductance measurement.
  3. Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may impact cue reactivity.
  4. Subjects who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (except nicotine) for 24 hours prior the cue procedures.
  5. Subjects meeting DSM-IV criteria for substance dependence (other than nicotine or methamphetamine as appropriate) within the past 60 days.
  6. Subjects currently taking B-blockers, anti-arrhythmic agents, psychostimulants or any other agents known to interfere with heart rate and skin conductance monitoring.
  7. Known or suspected hypersensitivity to modafinil.
  8. Individuals taking medications that could adversely interact with study medications.
  9. Subjects with a history of epilepsy or seizure disorder.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00751023
Other Study ID Numbers  ICMJE HR#18440
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bryan K Tolliver, MD, PhD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date May 2019

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