Modafinil Treatment for Cocaine-Dependent Individuals

NCT00129285 | Completed Phase 2 Results

• 4 other identifiers: NIDA-15366-1R01DA015366DPMC704450
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

Despite years of active research, there are still no approved medications for the treatment of cocaine dependence. The purpose of this study is to determine the effectiveness of modafinil in treating cocaine-dependent individuals.

Conditions

Cocaine-Related Disorders

Keywords

cocaine

Outcome Measures

Primary Outcomes (1)

• Urine Toxicology for Cocaine

  Abstinent in the final 3 weeks of treatment

  3 weeks

Secondary Outcomes (2)

• Retention; Number of Evaluation Visits Attended

  8 weeks

• Cocaine Selective Severity Assessment (CSSA) Total Score

  8 weeks

Study Arms (3)

Low Dose Modafinil

EXPERIMENTAL

Low Dose Modafinil 200 mg daily

Drug: Low Dose Modafinil

High Dose Modafinil

EXPERIMENTAL

High dose modafinil 400 mg daily

Drug: High Dose Modafinil

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Low Dose Modafinil DRUG

modafinil 200 mg/day

Also known as: Provigil

Low Dose Modafinil

High Dose Modafinil DRUG

modafinil 400 mg/day

Also known as: Provigil

High Dose Modafinil

Placebo DRUG

placebo 400 mg/day

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, aged 18 - 60 years;
• Current DSM-IV diagnosis of cocaine dependence
• Using at least $200 worth of cocaine within the past 30 days and having positive urine toxicology (BE) during screening;
• Able to provide written informed consent and to comply with all study procedures;
• 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 \[IUD\])

You may not qualify if:

• Currently dependent on any substance other than cocaine or nicotine
• Neurological or psychiatric disorders, such as psychosis, bipolar illness, organic brain disease, dementia, or any diseases that require psychotropic medications
• 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;
• 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;
• Clinically significant abnormal laboratory values
• 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);
• 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;
• Currently taking any medication that could interact adversely with one of the medications under study, including propranolol, phenytoin, warfarin and diazepam
• Took monoamine oxidase inhibitors (MAOI) within 30 days prior to randomization;
• Taking or has taken an investigational drug within 60 days prior to enrollment
• 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;
• Received therapy with any opiate-substitute (methadone, LAAM, buprenorphine) within 60 days of study enrollment.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104 6178, United States

Location

Related Links

• Click here for more information about the University of Pennsylvania Treatment Research Center's current studies

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Kyle Kampman
• Organization: University of Pennsylvania Treatment Research Center

kampman@mail.med.upenn.edu

215-746-2764

Study Officials

• Charles Dackis

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2005
• First Posted: August 11, 2005
• Study Start: July 1, 2004
• Primary Completion: January 1, 2008
• Study Completion: April 1, 2008
• Last Updated: May 8, 2018
• Results First Posted: May 8, 2018

Record last verified: 2018-04

Locations

US (1)