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Modafinil Treatment for Cocaine-Dependent Individuals

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ClinicalTrials.gov Identifier: NCT00129285
Recruitment Status : Completed
First Posted : August 11, 2005
Results First Posted : May 8, 2018
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
Despite years of active research, there are still no approved medications for the treatment of cocaine dependence. The purpose of this study is to determine the effectiveness of modafinil in treating cocaine-dependent individuals.

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Drug: Low Dose Modafinil Drug: High Dose Modafinil Drug: Placebo Phase 2

Detailed Description:

Modafinil is a glutamate-enhancing agent that blunts cocaine euphoria under controlled conditions. Due to its stimulant-like properties, modafinil is also likely to relieve severe cocaine withdrawal symptoms. In turn, this may lead to better clinical outcomes. The purpose of this study is to determine whether modafinil improves abstinence during early recovery from cocaine dependence.

This 6-month, double-blind, placebo-controlled trial will enroll 210 participants with current DSM-IV diagnoses of cocaine dependence. Treatment will occur for 8 weeks. Participants will be randomly assigned to receive a single morning dose of low-dose modafinil (200 mg/day), high-dose modafinil (400 mg/day), or matching placebo tablets. In addition, each week participants will receive manual-guided cognitive behavioral therapy at the Treatment Research Center. At the end of the 8-week treatment period, modafinil or placebo will be abruptly discontinued. One week following, an end of medication evaluation will occur. In addition to this, two follow-up evaluations will take place 3 and 5 months after initial randomization. Efforts will be made to continue evaluation of subjects who decide to discontinue the modafinil treatment. Urine benzoylecgonine levels will be used to measure cocaine abstinence. Craving, withdrawal, retention, and adverse events will also be evaluated.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study of Modafinil for Cocaine Dependence
Study Start Date : July 2004
Actual Primary Completion Date : January 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low Dose Modafinil
Low Dose Modafinil 200 mg daily
Drug: Low Dose Modafinil
modafinil 200 mg/day
Other Name: Provigil

Experimental: High Dose Modafinil
High dose modafinil 400 mg daily
Drug: High Dose Modafinil
modafinil 400 mg/day
Other Name: Provigil

Placebo Comparator: Placebo
Placebo
Drug: Placebo
placebo 400 mg/day




Primary Outcome Measures :
  1. Urine Toxicology for Cocaine [ Time Frame: 3 weeks ]
    Abstinent in the final 3 weeks of treatment


Secondary Outcome Measures :
  1. Retention; Number of Evaluation Visits Attended [ Time Frame: 8 weeks ]
    Number of visits attended compared between the three conditions using anova

  2. Cocaine Selective Severity Assessment (CSSA) Total Score [ Time Frame: 8 weeks ]
    Cocaine Selective Severity assessment (CSSA) total score has a range 0-126. Higher scores indicating greater severity of cocaine withdrawal obtained weekly. Groups compared using GEE model over 8 weeks of treatment.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, aged 18 - 60 years;
  • Current DSM-IV diagnosis of cocaine dependence
  • Using at least $200 worth of cocaine within the past 30 days and having positive urine toxicology (BE) during screening;
  • Able to provide written informed consent and to comply with all study procedures;
  • Women must be surgically sterile, at least two years postmenopausal, or if of childbearing potential be using a medically accepted method of birth control and agree to continue use of this method for at least 30 days after the last dose of study drug (i.e. barrier method with spermicide, steroidal contraceptive [oral and implanted, including Depo-Provera contraceptives must be used in conjunction with a barrier method], or intrauterine device [IUD])

Exclusion Criteria:

  • Currently dependent on any substance other than cocaine or nicotine
  • Neurological or psychiatric disorders, such as psychosis, bipolar illness, organic brain disease, dementia, or any diseases that require psychotropic medications
  • Serious medical illnesses, including but not limited to; uncontrolled hypertension, significant heart disease (including a history of myocardial infarction, angina, mitral valve prolapse, left ventricular hypertrophy, palpitations, and arrhythmia), hepatic disease, renal disease, or any serious, potentially life-threatening or progressive medical illness that may compromise patient safety or study conduct;
  • Received a drug with known potential for toxicity to a major organ system within the month prior to entering treatment including but not limited to; chemotherapeutic agents for neoplastic disease (i.e. methotrexate, vincristine, vinblastine, fluorouracil), agents used for parasitic infections, isoniazid, chlorambucil, dactinomycin, chloramphenicol, immunosuppressive and cytotoxic agents (i.e. cyclosporine, tacrolimus), indomethacin, protease inhibitors, amphotericin B, cephalosporins, aminoglycosides, interferon, and sulfonamides;
  • Clinically significant abnormal laboratory values
  • Has any disease of the gastrointestinal system, liver, or kidneys which could result in altered metabolism or excretion of the study medication (history of major gastrointestinal tract surgery, gastrectomy, gastrostomy, bowel resection, etc.) or history of chronic gastrointestinal disorders (ulcerative colitis, regional enteritis, or gastrointestinal bleeding);
  • Known hypersensitivity or allergy to modafinil or receiving chronic therapy with any medication that could interact adversely with one of the medications under study, including propranolol, phenytoin, warfarin and diazepam;
  • Currently taking any medication that could interact adversely with one of the medications under study, including propranolol, phenytoin, warfarin and diazepam
  • Took monoamine oxidase inhibitors (MAOI) within 30 days prior to randomization;
  • Taking or has taken an investigational drug within 60 days prior to enrollment
  • If female and of child-bearing capacity, tests positive on a urine pregnancy test, is lactating, has had three or more days of amenorrhea beyond expected menses at the time of the first dose of study medication, is contemplating pregnancy in the next 6 months, or is not using an effective contraceptive method;
  • Received therapy with any opiate-substitute (methadone, LAAM, buprenorphine) within 60 days of study enrollment.

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 ClinicalTrials.gov identifier (NCT number): NCT00129285


Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104 6178
Sponsors and Collaborators
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Charles Dackis University of Pennsylvania

Additional Information:
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00129285     History of Changes
Other Study ID Numbers: NIDA-15366-1
R01DA015366 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
704450
First Posted: August 11, 2005    Key Record Dates
Results First Posted: May 8, 2018
Last Update Posted: May 8, 2018
Last Verified: April 2018

Keywords provided by University of Pennsylvania:
cocaine

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Modafinil
Armodafinil
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers