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Community-Based Modafinil Treatment of Women With Cocaine Dependence and HIV-High Risk Behavior (MOD5)
This study is currently recruiting participants.
Verified by University of Pennsylvania, January 2009
First Received: August 22, 2006   Last Updated: January 5, 2009   History of Changes
Sponsored by: University of Pennsylvania
Information provided by: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00368290
  Purpose

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


Condition Intervention Phase
Cocaine Dependence
Drug: Modafinil
Drug: placebo
Behavioral: Telephone Monitoring and Adaptive Counseling (TMAC)
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Community-Based Modafinil Treatment of Women With Cocaine Dependence and HIV-High Risk Behavior

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • High Risk Behavior as measured by the Risk Assessment Battery [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Cocaine use as measured by urine drug screen [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2006
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
modafinil plus TMAC
Drug: Modafinil
300mg a day 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.
2: Placebo Comparator
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
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 and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00368290

Contacts
Contact: Thea L Gallis 215-222-3200 ext 131 gallis_t@mail.trc.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Donna Simpson     215-243-9959        
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Charles Dackis, M.D. University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania ( Charles Dackis, MD )
Study ID Numbers: 804537
Study First Received: August 22, 2006
Last Updated: January 5, 2009
ClinicalTrials.gov Identifier: NCT00368290     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
cocaine dependence
hiv prevention

Study placed in the following topic categories:
Cocaine-Related Disorders
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Acquired Immunodeficiency Syndrome
Central Nervous System Depressants
Anesthetics
Disorders of Environmental Origin
Central Nervous System Stimulants
Cardiovascular Agents
Neuroprotective Agents
Anesthetics, Local
Modafinil
Dopamine
HIV Infections
Mental Disorders
Substance-Related Disorders
Vasoconstrictor Agents
Dopamine Agents
Peripheral Nervous System Agents
Cocaine

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Disorders of Environmental Origin
Anesthetics
Neuroprotective Agents
Modafinil
Mental Disorders
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents
Substance-Related Disorders
Cocaine
Cocaine-Related Disorders
Central Nervous System Depressants
Central Nervous System Stimulants
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Anesthetics, Local
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009