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History of Changes for Study: NCT00368290
Modafinil Treatment for Cocaine Dependence and HIV High-Risk Behavior (MOD6)
Latest version (submitted February 19, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 22, 2006 Nothing (earliest Version on record)
2 January 18, 2007
Recruitment Status
, Study Status and Contacts/Locations
3 May 9, 2008 Study Status, Arms and Interventions, Study Design, Outcome Measures, Study Description, Oversight, Sponsor/Collaborators and Study Identification
4 January 5, 2009 Contacts/Locations and Study Status
5 July 23, 2009 Arms and Interventions, Eligibility, Study Description, Study Status and Contacts/Locations
6 January 21, 2010 Contacts/Locations, Study Identification, Study Status and Eligibility
7 June 18, 2010 Study Status, Study Identification, Contacts/Locations and Eligibility
8 September 22, 2010 Study Status, Eligibility and Sponsor/Collaborators
9 February 17, 2011 Contacts/Locations and Study Status
10 November 10, 2011 Contacts/Locations and Study Status
11 June 13, 2012 Study Status and Contacts/Locations
12 April 24, 2013
Recruitment Status
, Sponsor/Collaborators, Study Status, Contacts/Locations and Study Design
13 October 15, 2013 Study Status
14 December 12, 2013 Study Status, Outcome Measures and Results
15 February 19, 2018 Study Status, Reported Adverse Events and More Information
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Study NCT00368290
on Date:  December 12, 2013 (v14)

Study Identification
Unique Protocol ID: 804537
Brief Title: Modafinil Treatment for Cocaine Dependence and HIV High-Risk Behavior (MOD6)
Official Title: Modafinil Treatment for Cocaine Dependence and HIV-High Risk Behavior
Secondary IDs:
Study Status
Record Verification: December 2013
Overall Status: Completed
Study Start: September 2006
Primary Completion: January 2013 [Actual]
Study Completion: January 2013 [Actual]
First Submitted: August 22, 2006
First Submitted that
Met QC Criteria:
August 22, 2006
First Posted: August 24, 2006 [Estimate]
Results First Submitted: December 12, 2013
Results First Submitted that
Met QC Criteria:
December 12, 2013
Results First Posted: January 29, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 12, 2013
Last Update Posted: January 29, 2014 [Estimate]
Sponsor/Collaborators
Sponsor: Kyle Kampman
Responsible Party: Sponsor-Investigator
Investigator: Kyle Kampman
Official Title: Sponsor-Investigator
Affiliation: University of Pennsylvania
Collaborators:
Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Study Description
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).
Conditions
Conditions: Cocaine Dependence
Keywords: cocaine dependence
hiv prevention
Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: QuadrupleParticipant, Care Provider, Investigator, Outcomes Assessor
Allocation: Randomized
Enrollment: 94 [Actual]
Arms and Interventions
Arms Assigned Interventions
Experimental: 1
modafinil plus CBT
Drug: Modafinil
300mg a day for 8 weeks

Other Names:
  • 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.
Outcome Measures
Eligibility
Minimum Age: 18 Years
Maximum Age: 60 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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.
Contacts/Locations
Study Officials: Kyle M Kampman, M.D.
Principal Investigator
University of Pennsylvania
Locations:
IPDSharing
Plan to Share IPD:
References
Citations:
Links:
Available IPD/Information:
Study Results
Participant Flow
Reporting Groups
Description
Modafinil

modafinil plus CBT

Modafinil: 300mg a day for 8 weeks

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

Placebo

placebo plus CBT

placebo: placebo pills for 8 weeks

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

Overall Study
  Modafinil Placebo
Started 47 47
Completed 34 37
Not Completed 13 10
Baseline Characteristics
Reporting Groups
Description
Modafinil

modafinil plus CBT

Modafinil: 300mg a day for 8 weeks

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

Placebo

placebo plus CBT

placebo: placebo pills for 8 weeks

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

Baseline Measures
    Modafinil Placebo Total
Overall Number of Participants 47 47 94
Age, Categorical
Measure type: Count of Participants
Unit of measure: Participants
Number Analyzed47 Participants47 Participants94 Participants
<=18 years0 0%0 0%0 0%
Between 18 and 65 years47 100%47 100%94 100%
>=65 years0 0%0 0%0 0%
Sex: Female, Male
Measure type: Count of Participants
Unit of measure: Participants
Number Analyzed47 Participants47 Participants94 Participants
Female9 19.15%8 17.02%17 18.09%
Male38 80.85%39 82.98%77 81.91%
Region of Enrollment
Measure type: Number
Unit of measure: participants
Number Analyzed47 Participants47 Participants94 Participants
United States
474794
Outcome Measures
1. Primary Outcome Measure:
Measure Title Percent of Participants Reporting no Cocaine Craving
Measure Description Percent of participants reporting no cocaine craving based on Brief Substance Craving Scale (BSCS) - a 4 point likert scale.
Time Frame 8 weeks
Analysis Population Description
[Not Specified]
Reporting Groups
Description
Modafinil

modafinil plus CBT

Modafinil: 300mg a day for 8 weeks

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

Placebo

placebo plus CBT

placebo: placebo pills for 8 weeks

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

Measured Values
  Modafinil Placebo
Overall Number of Participants Analyzed 47 47
Percent of Participants Reporting no Cocaine Craving
Measure Type: Number
Unit of Measure: Percent of participants
64 41
2. Primary Outcome Measure:
Measure Title Cocaine Use as Measured by Urine Drug Screen
Measure Description 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.
Time Frame 8 weeks
Analysis Population Description
[Not Specified]
Reporting Groups
Description
Modafinil

modafinil plus CBT

Modafinil: 300mg a day for 8 weeks

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

Placebo

placebo plus CBT

placebo: placebo pills for 8 weeks

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

Measured Values
  Modafinil Placebo
Overall Number of Participants Analyzed 47 47
Cocaine Use as Measured by Urine Drug Screen
Measure Type: Number
Unit of Measure: Percentage of Participants
23 9
Reported Adverse Events
Time Frame [Not specified]
Adverse Event Reporting Description [Not specified]
Reporting Groups
Description
Modafinil

modafinil plus CBT

Modafinil: 300mg a day for 8 weeks

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

Placebo

placebo plus CBT

placebo: placebo pills for 8 weeks

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

All-Cause Mortality
  Modafinil Placebo
 Affected/At Risk (%)# Events Affected/At Risk (%)# Events
Total //
Serious Adverse Events
  Modafinil Placebo
 Affected/At Risk (%)# Events Affected/At Risk (%)# Events
Total 6/47 (12.77%)9/47 (19.15%)
Eye disorders
Hospitalization for eye injury [1] 0/47 (0%)01/47 (2.13%)1
General disorders
Exacerbation of Cocaine Dependence [2] 3/47 (6.38%)45/47 (10.64%)5
Loss of Conciousness [3] 1/47 (2.13%)10/47 (0%)0
Infections and infestations
Infection in laceration on right hand 0/47 (0%)01/47 (2.13%)1
Psychiatric disorders
Hospitalization for Depression [4] 1/47 (2.13%)12/47 (4.26%)2
Respiratory, thoracic and mediastinal disorders
Hospitalization for Asthama [5] 1/47 (2.13%)20/47 (0%)0
[1]Subject was hospitalized for eye surgery
[2]Subject's cocaine dependence let subject to enter an inpatient program.
[3]Subject was driving and reportedly lost consciousness, causing his car to hit the side of a house. The expected charges are driving under the influence and malicious mischief with a motor vehicle.
[4]Subject entered psychiatric treatment facility
[5]Subject hospitalized for worsening asthma symptoms
Other Adverse Events
Frequency Threshold Above Which Other Adverse Events are Reported: 5%
  Modafinil Placebo
 Affected/At Risk (%)# Events Affected/At Risk (%)# Events
Total 23/47 (48.94%)12/47 (25.53%)
General disorders
Headache 6/47 (12.77%)7/47 (14.89%)
Insomnia 10/47 (21.28%)3/47 (6.38%)
Psychiatric disorders
Anxiety 7/47 (14.89%)2/47 (4.26%)
Limitations and Caveats
[Not specified]
More Information
Certain Agreements:
Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact:
Name/Official Title: Dr. Kyle Kampman
Organization: University of Pennsylvania
Phone: 215-222-3200 ext.109
Email: kampman@mail.med.upenn.edu

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