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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
Comparison Format:

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Study NCT00368290
on Date:  May 9, 2008 (v3)

Study Identification
Unique Protocol ID: 804537
Brief Title: Community-Based Modafinil Treatment of Women With Cocaine Dependence and HIV-High Risk Behavior (MOD5)
Official Title: Community-Based Modafinil Treatment of Women With Cocaine Dependence and HIV-High Risk Behavior
Secondary IDs:
Study Status
Record Verification: May 2008
Overall Status: Recruiting
Study Start: September 2006
Primary Completion: June 2012 [Anticipated]
Study Completion: June 2012 [Anticipated]
First Submitted: August 22, 2006
First Submitted that
Met QC Criteria:
August 22, 2006
First Posted: August 24, 2006 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 9, 2008
Last Update Posted: May 14, 2008 [Estimate]
Sponsor/Collaborators
Sponsor: University of Pennsylvania
Responsible Party:
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 women.
Detailed Description: The purpose of study is to determine if modafinil promotes cocaine abstinence and reduces HRB in cocaine dependent women. 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 Telephone Monitoring and Adaptive Counseling (TMAC).
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: 200 [Anticipated]
Arms and Interventions
Arms Assigned Interventions
Experimental: 1
modafinil plus TMAC
Drug: Modafinil
300mg a day for 8 weeks

Other Names:
  • Provigil
Behavioral: Telephone Monitoring and Adaptive Counseling (TMAC)
Weekly telephone counseling sessions for a period of 8 weeks following a 1hr face-to-face interview.
Placebo Comparator: 2
placebo plus TMAC
Drug: placebo
placebo pills for 8 weeks
Behavioral: Telephone Monitoring and Adaptive Counseling (TMAC)
Weekly telephone counseling sessions for a period of 8 weeks following a 1hr face-to-face interview.
Outcome Measures
Primary Outcome Measures:
1. High Risk Behavior as measured by the Risk Assessment Battery
8 weeks
2. Cocaine Use as Measured by Urine Drug Screen
8 weeks
Eligibility
Minimum Age: 18 Years
Maximum Age: 60 Years
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Female, aged 18 - 60 years;
  2. Current DSM-IV diagnosis of cocaine dependence;
  3. Using at least $200 worth of cocaine within the past 30 days, using cocaine at least 8 days/month, and having positive urine toxicology (BE) during screening;
  4. Sexually active
  5. Able to provide written informed consent and to comply with all study procedures;
  6. 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. Not sexually active or engaged in any HRB for the past 30 days;
  3. Neurological or psychiatric disorders, such as psychosis, bipolar illness, organic brain disease, dementia, or any diseases that require psychotropic medications;
  4. 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;
  5. 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;
  6. Clinically significant abnormal laboratory values;
  7. 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);
  8. 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;
  9. Took monoamine oxidase inhibitors (MAOI) within 30 days prior to randomization;
  10. Taking or has taken an investigational drug within 60 days prior to randomization;
  11. 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;
  12. Received therapy with any opiate-substitute (methadone, LAAM, buprenorphine) within 60 days of study enrollment.
Contacts/Locations
Central Contact: Sarah Farash
Telephone: 215-222-3200 Ext. 150
Email: farash_s@mail.trc.upenn.edu
Study Officials: Charles Dackis, M.D.
Principal Investigator
University of Pennsylvania
Locations: United States, Pennsylvania
University of Pennsylvania
[Recruiting]
Philadelphia, Pennsylvania, United States, 19104
Contact: Donna Simpson 215-243-9959
IPDSharing
Plan to Share IPD:
References
Citations:
Links:
Available IPD/Information:

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