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Modafinil Treatment for Cocaine Dependence and HIV High-Risk Behavior (MOD6)

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: NCT00368290
Recruitment Status : Completed
First Posted : August 24, 2006
Results First Posted : January 29, 2014
Last Update Posted : March 15, 2018
Information provided by (Responsible Party):
Kyle Kampman, University of Pennsylvania

Brief Summary:
The purpose of study is to determine if modafinil promotes cocaine abstinence and reduces high risk behavior in cocaine dependent subjects.

Condition or disease Intervention/treatment Phase
Cocaine Dependence Drug: Modafinil Drug: placebo Behavioral: Cognitive Behavioral Therapy (CBT) Phase 2

Detailed Description:
The purpose of study is to determine if modafinil promotes cocaine abstinence and reduces HRB in cocaine dependent subjects. Modafinil (300 mg/day) or placebo will be administered in an 8-week double-blind trial to patients meeting diagnostic criteria for cocaine dependence in conjunction with Cognitive Behavioral Therapy (CBT).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modafinil Treatment for Cocaine Dependence and HIV-High Risk Behavior
Study Start Date : September 2006
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Modafinil

Arm Intervention/treatment
Experimental: 1
modafinil plus CBT
Drug: Modafinil
300mg a day for 8 weeks
Other Name: Provigil

Behavioral: Cognitive Behavioral Therapy (CBT)
Weekly cognitive behavioral therapy sessions for a period of 8 weeks.

Placebo Comparator: 2
placebo plus CBT
Drug: placebo
placebo pills for 8 weeks

Behavioral: Cognitive Behavioral Therapy (CBT)
Weekly cognitive behavioral therapy sessions for a period of 8 weeks.

Primary Outcome Measures :
  1. Percent of Participants Reporting no Cocaine Craving [ Time Frame: 8 weeks ]
    Percent of participants reporting no cocaine craving based on Brief Substance Craving Scale (BSCS) - a 4 point likert scale.

  2. Cocaine Use as Measured by Urine Drug Screen [ Time Frame: 8 weeks ]
    The primary outcome measure was cocaine use measured by self-report, and confirmed by twice weekly urine drug screens. The percentage of participants shows the percentage who were abstinent from cocaine during the last 3 weeks of the trial.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  1. 18 - 60 years;
  2. Current DSM-IV diagnosis of cocaine dependence;
  3. Using cocaine at least 8 days in a consecutive 30 day period over the 60 day period immediately preceding study entry (If subject was receiving inpatient substance abuse treatment within 30 days prior to screening, subject must have been using cocaine at least 8 days in a consecutive 30 day period over the 60 day period immediately preceding admission to inpatient treatment); 4.)Having a negative urine toxicology (BE) test during screening (no less than 5 days prior to randomization) and a negative urine toxicology (BE) test on the day of randomization. Repeat testing allowed until required negative BE results are obtained;
  4. Able to provide written informed consent and to comply with all study procedures;
  5. 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:

  1. Currently dependent on any substance other than cocaine or nicotine;
  2. Current Neurological or psychiatric disorders, such as psychosis, bipolar illness, organic brain disease, dementia, or any diseases that require psychotropic medications;
  3. 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;
  4. 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;
  5. Clinically significant abnormal laboratory values (see Appendix A);
  6. 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);
  7. Known hypersensitivity or allergy to modafinil, or receiving chronic therapy with any medication that could interact adversely with modafinil, including propranolol, phenytoin, warfarin and diazepam;
  8. Took monoamine oxidase inhibitors (MAOI) within 30 days prior to randomization;
  9. Taking or has taken an investigational drug within 60 days prior to randomization;
  10. 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;
  11. 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 identifier (NCT number): NCT00368290

Sponsors and Collaborators
Kyle Kampman
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Principal Investigator: Kyle M Kampman, M.D. University of Pennsylvania
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Responsible Party: Kyle Kampman, Sponsor-Investigator, University of Pennsylvania Identifier: NCT00368290    
Other Study ID Numbers: 804537
First Posted: August 24, 2006    Key Record Dates
Results First Posted: January 29, 2014
Last Update Posted: March 15, 2018
Last Verified: February 2018
Keywords provided by Kyle Kampman, University of Pennsylvania:
cocaine dependence
hiv prevention
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