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| Sponsor: | National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00129285 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cocaine-Related Disorders |
Drug: Modafinil Low Dose Drug: Modafinil High Dose Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Placebo-Controlled Study of Modafinil for Cocaine Dependence |
| Enrollment: | 210 |
| Study Start Date: | July 2004 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Low Dose Modafinil
|
Drug: Modafinil Low Dose
modafinil 200 mg/day
Other Name: Provigil
|
|
Experimental: 2
High Dose Modafinil
|
Drug: Modafinil High Dose
modafinil 400 mg/day
Other Name: Provigil
|
|
Placebo Comparator: 3
Placebo
|
Drug: Placebo
placebo 400 mg/day
|
Modafinil is a glutamate-enhancing agent that blunts cocaine euphoria under controlled conditions. Due to its stimulant-like properties, modafinil is also likely to relieve severe cocaine withdrawal symptoms. In turn, this may lead to better clinical outcomes. The purpose of this study is to determine whether modafinil improves abstinence during early recovery from cocaine dependence.
This 6-month, double-blind, placebo-controlled trial will enroll 210 participants with current DSM-IV diagnoses of cocaine dependence. Treatment will occur for 8 weeks. Participants will be randomly assigned to receive a single morning dose of low-dose modafinil (200 mg/day), high-dose modafinil (400 mg/day), or matching placebo tablets. In addition, each week participants will receive manual-guided cognitive behavioral therapy at the Treatment Research Center. At the end of the 8-week treatment period, modafinil or placebo will be abruptly discontinued. One week following, an end of medication evaluation will occur. In addition to this, two follow-up evaluations will take place 3 and 5 months after initial randomization. Efforts will be made to continue evaluation of subjects who decide to discontinue the modafinil treatment. Urine benzoylecgonine levels will be used to measure cocaine abstinence. Craving, withdrawal, retention, and adverse events will also be evaluated.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 6178 | |
| Principal Investigator: | Charles Dackis | University of Pennsylvania |
More Information
| Responsible Party: | Charles A. Dackis, MD, University of Pennsylvania Treatment Research Cener |
| ClinicalTrials.gov Identifier: | NCT00129285 History of Changes |
| Other Study ID Numbers: | NIDA-15366-1, R01DA015366, DPMC, 704450 |
| Study First Received: | August 4, 2005 |
| Last Updated: | December 28, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Cocaine-Related Disorders Substance-Related Disorders Mental Disorders Modafinil Central Nervous System Stimulants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Neuroprotective Agents Protective Agents |