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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

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.

Condition or disease Intervention/treatment Phase
Cocaine Dependence Drug: Modafinil Drug: Matching Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: CBT and Modafinil for Cocaine Addiction
Study Start Date : April 2004
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 200mg Modafinil
200mg Modafinil
Drug: Modafinil
200mg Modafinil
Other Name: Provigil

Experimental: 400mg Modafinil
400mg Modafinil
Drug: Modafinil
400mg Modafinil
Other Name: Provigil

Placebo Comparator: Matching Placebo
Matching Placebo
Drug: Matching Placebo
Matching Placebo

Primary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00218387

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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Robert Malcolm, MD Medical University of South Carolina
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Responsible Party: Robert Malcolm, Professor of Psychiatry, Family Medicine & Pediatrics, Medical University of South Carolina Identifier: NCT00218387    
Other Study ID Numbers: NIDA-16368-1
R01DA016368 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2005    Key Record Dates
Results First Posted: April 10, 2019
Last Update Posted: April 10, 2019
Last Verified: March 2019
Keywords provided by Robert Malcolm, Medical University of South Carolina:
Cocaine Dependence
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action