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Modafinil Combined With Cognitive Behavior Therapy to Treat Cocaine Addiction - 1

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: NCT00218387
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : April 10, 2019
Last Update Posted : April 10, 2019
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Robert Malcolm, Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE September 16, 2005
First Posted Date  ICMJE September 22, 2005
Results First Submitted Date  ICMJE December 19, 2018
Results First Posted Date  ICMJE April 10, 2019
Last Update Posted Date April 10, 2019
Study Start Date  ICMJE April 2004
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
  • Number of Cocaine Non-use Days [ Time Frame: 8 weeks ]
    Number of cocaine non-use days was determined by Urine Drug Screen tests which confirmed presence (or no presence) of benzoylecgonine levels.
  • Percent of Participants With New Use [ Time Frame: 8 weeks ]
    New Use is defined as a period of at least 7 days abstinence followed by a positive urine drug screen.
Original Primary Outcome Measures  ICMJE
 (submitted: September 16, 2005)
To determine whether standard manual-driven cognitive behavioral therapy (CBT) for cocaine dependence with modafinil 200 mg or 400 mg daily will be more effective than CBT and identical placebo.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Modafinil Combined With Cognitive Behavior Therapy to Treat Cocaine Addiction - 1
Official Title  ICMJE CBT and Modafinil for Cocaine Addiction
Brief Summary Cocaine addiction is a serious health problem with no available medical treatment for preventing relapse. Modafinil, a medication that enhances mood, increases energy, and improves concentration, may be useful in preventing relapse among individuals with cocaine addiction. This study will evaluate the effectiveness of modafinil, in combination with cognitive behavior therapy (CBT), to prevent drug relapse among cocaine addicts.
Detailed Description

The development of a medication to treat cocaine addiction specifically by lessening withdrawal symptoms has been a primary focus of research. Common cocaine withdrawal symptoms include depression, lack of energy, and poor concentration. Modafinil, a central nervous system stimulant, is a medication that can speed up physical and mental processes in the brain. It is currently used to treat narcolepsy, a condition that causes excessive sleepiness. Modafinil enhances mood, increases energy, and improves concentration in people with narcolepsy. Modafinil may also cause the same effects in individuals addicted to cocaine, thereby countering the symptoms of cocaine withdrawal. The purpose of this study is to compare the effectiveness of modafinil plus CBT versus placebo plus CBT for treating cocaine dependence.

A 2-week screening period will be followed by an 8-week treatment phase. Participants will be randomly assigned to receive either 200 mg of modafinil, 400 mg of modafinil, or placebo on a daily basis for the 8 weeks of treatment. During this time, participants will be asked to report the number of days that they use and do not use cocaine. This will be confirmed three times a week with urine tests. Mood, level of daytime sleepiness, and symptoms of cocaine withdrawal and cocaine "high" will be evaluated. Compliance with study medication will be assessed with urine and blood tests. Medication side effects will be monitored through physical examinations, routine lab tests, ECGs, and self-reports. Follow-up evaluations will occur 4 and 8 weeks following the end of treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cocaine Dependence
Intervention  ICMJE
  • Drug: Modafinil
    200mg Modafinil
    Other Name: Provigil
  • Drug: Modafinil
    400mg Modafinil
    Other Name: Provigil
  • Drug: Matching Placebo
    Matching Placebo
Study Arms  ICMJE
  • Experimental: 200mg Modafinil
    200mg Modafinil
    Intervention: Drug: Modafinil
  • Experimental: 400mg Modafinil
    400mg Modafinil
    Intervention: Drug: Modafinil
  • Placebo Comparator: Matching Placebo
    Matching Placebo
    Intervention: Drug: Matching Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 20, 2019)
Original Enrollment  ICMJE
 (submitted: September 16, 2005)
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:

  • Seeking treatment for cocaine dependence
  • Meets DSM-IV diagnosis criteria for cocaine dependence as determined by Mini-SCID interview
  • If female, willing to use effective contraception throughout the study
  • Lives within 50 miles of the research center and has reliable transportation

Exclusion criteria:

  • Meets DSM-IV/Mini-SCID diagnosis criteria for dependence on any drugs other than cocaine, alcohol, nicotine, or marijuana
  • Physiologic dependence on alcohol requiring medical detoxification, on either an inpatient or outpatient basis
  • Current psychiatric disorder, including depression, schizophrenia, bipolar affective disorder, organic brain disease, dementia, or other types of psychosis
  • Recent suicidal or homicidal attempts within 60 days of study entry
  • Suicidal or homicidal ideation within 30 days of study entry
  • Meets diagnosis criteria from the Differential Diagnosis of Psychotic Disorders section of Mini-SCID for a history of psychotic symptoms during a period of cocaine use (e.g., persistent hallucinations and delusions)
  • Serious medical illness, including left ventricular hypertrophy, mitral valve prolapse, left bundle branch block, heart attack, angina, serious liver disease (transaminase levels four times greater than normal), and kidney, neurologic, metabolic, neoplastic, nutritional, inflammatory, or endocrine disorders
  • Required by the court to obtain treatment for cocaine dependence
  • Not seeking treatment for cocaine dependence
  • Participated in cocaine treatment (clinical or research) within 30 days of study entry
  • Anticipating elective surgery or hospitalization within 20 weeks of study entry
  • Known or suspected hypersensitivity to modafinil
  • Use of any of the following medications within 14 days of study entry: selective serotonin reuptake inhibitor antidepressants, tricyclic antidepressants, dopamine agonists, and other psychotropic medications, including anticonvulsants, antipsychotics, anxiolytics, or psychostimulants
  • Currently taking medications that could adversely interact with study medications, including azole-type antifungals, cyclosporine, warfarin, theophylline, or carbamazepine
  • Currently taking any medications that induce or inhibit CYP3A4 metabolic pathways
  • Pregnant or breastfeeding
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 NCT00218387
Other Study ID Numbers  ICMJE NIDA-16368-1
R01DA016368 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert Malcolm, Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Robert Malcolm, MD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date March 2019

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