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Trial record 1 of 2 for:    Modafinil | Kampman [Lead]
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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.
 
ClinicalTrials.gov Identifier: NCT00368290
Recruitment Status : Completed
First Posted : August 24, 2006
Results First Posted : January 29, 2014
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Kyle Kampman, University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE August 22, 2006
First Posted Date  ICMJE August 24, 2006
Results First Submitted Date  ICMJE December 12, 2013
Results First Posted Date  ICMJE January 29, 2014
Last Update Posted Date March 15, 2018
Study Start Date  ICMJE September 2006
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2013)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
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 Treatment for Cocaine Dependence and HIV High-Risk Behavior
Official Title  ICMJE Modafinil Treatment for Cocaine Dependence and HIV-High Risk Behavior
Brief Summary The purpose of study is to determine if modafinil promotes cocaine abstinence and reduces high risk behavior in cocaine dependent subjects.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cocaine Dependence
Intervention  ICMJE
  • Drug: Modafinil
    300mg a day for 8 weeks
    Other Name: Provigil
  • Drug: placebo
    placebo pills for 8 weeks
  • Behavioral: Cognitive Behavioral Therapy (CBT)
    Weekly cognitive behavioral therapy sessions for a period of 8 weeks.
Study Arms  ICMJE
  • Experimental: 1
    modafinil plus CBT
    Interventions:
    • Drug: Modafinil
    • Behavioral: Cognitive Behavioral Therapy (CBT)
  • Placebo Comparator: 2
    placebo plus CBT
    Interventions:
    • Drug: placebo
    • Behavioral: Cognitive Behavioral Therapy (CBT)
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: April 24, 2013)
94
Original Enrollment  ICMJE
 (submitted: August 22, 2006)
200
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00368290
Other Study ID Numbers  ICMJE 804537
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kyle Kampman, University of Pennsylvania
Study Sponsor  ICMJE Kyle Kampman
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kyle M Kampman, M.D. University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date February 2018

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