| City: |
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Charleston |
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State:
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SC |
| Zip Code: |
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29425 |
| Conditions: |
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Cocaine Dependence |
| Purpose: |
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Cocaine addiction is a serious health problem with no available medical treatment for
preventing relapse. Modafinil, a medication that enhances mood, increases energy, and
improves concentration, may be useful in preventing relapse among individuals with cocaine
addiction. This study will evaluate the effectiveness of modafinil, in combination with
cognitive behavior therapy (CBT), to prevent drug relapse among cocaine addicts.
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| Study summary: |
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The development of a medication to treat cocaine addiction specifically by lessening
withdrawal symptoms has been a primary focus of research. Common cocaine withdrawal symptoms
include depression, lack of energy, and poor concentration. Modafinil, a central nervous
system stimulant, is a medication that can speed up physical and mental processes in the
brain. It is currently used to treat narcolepsy, a condition that causes excessive
sleepiness. Modafinil enhances mood, increases energy, and improves concentration in people
with narcolepsy. Modafinil may also cause the same effects in individuals addicted to
cocaine, thereby countering the symptoms of cocaine withdrawal. The purpose of this study is
to compare the effectiveness of modafinil plus CBT versus placebo plus CBT for treating
cocaine dependence.
A 2-week screening period will be followed by an 8-week treatment phase. Participants will
be randomly assigned to receive either 200 mg of modafinil, 400 mg of modafinil, or placebo
on a daily basis for the 8 weeks of treatment. During this time, participants will be asked
to report the number of days that they use and do not use cocaine. This will be confirmed
three times a week with urine tests. Mood, level of daytime sleepiness, and symptoms of
cocaine withdrawal and cocaine "high" will be evaluated. Compliance with study medication
will be assessed with urine and blood tests. Medication side effects will be monitored
through physical examinations, routine lab tests, ECGs, and self-reports. Follow-up
evaluations will occur 4 and 8 weeks following the end of treatment. |
| Criteria: |
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Inclusion Criteria:
- Seeking treatment for cocaine dependence
- Meets DSM-IV diagnosis criteria for cocaine dependence as determined by Mini-SCID
interview
- If female, willing to use effective contraception throughout the study
- Lives within 50 miles of the research center and has reliable transportation
Exclusion criteria:
- Meets DSM-IV/Mini-SCID diagnosis criteria for dependence on any drugs other than
cocaine, alcohol, nicotine, or marijuana
- Physiologic dependence on alcohol requiring medical detoxification, on either an
inpatient or outpatient basis
- Current psychiatric disorder, including depression, schizophrenia, bipolar affective
disorder, organic brain disease, dementia, or other types of psychosis
- Recent suicidal or homicidal attempts within 60 days of study entry
- Suicidal or homicidal ideation within 30 days of study entry
- Meets diagnosis criteria from the Differential Diagnosis of Psychotic Disorders
section of Mini-SCID for a history of psychotic symptoms during a period of cocaine
use (e.g., persistent hallucinations and delusions)
- Serious medical illness, including left ventricular hypertrophy, mitral valve
prolapse, left bundle branch block, heart attack, angina, serious liver disease
(transaminase levels four times greater than normal), and kidney, neurologic,
metabolic, neoplastic, nutritional, inflammatory, or endocrine disorders
- Required by the court to obtain treatment for cocaine dependence
- Not seeking treatment for cocaine dependence
- Participated in cocaine treatment (clinical or research) within 30 days of study
entry
- Anticipating elective surgery or hospitalization within 20 weeks of study entry
- Known or suspected hypersensitivity to modafinil
- Use of any of the following medications within 14 days of study entry: selective
serotonin reuptake inhibitor antidepressants, tricyclic antidepressants, dopamine
agonists, and other psychotropic medications, including anticonvulsants,
antipsychotics, anxiolytics, or psychostimulants
- Currently taking medications that could adversely interact with study medications,
including azole-type antifungals, cyclosporine, warfarin, theophylline, or
carbamazepine
- Currently taking any medications that induce or inhibit CYP3A4 metabolic pathways
- Pregnant or breastfeeding |
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| Study is available at: |
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Medical University of South Carolina
Charleston, SC 29425
United States
Primary Contact:
Kristi Huebner, MPH
Email: huebnerk@musc.edu
Phone: 843-792-1901
Secondary Contact:
Kristi Huebner, MPH
Email: huebnerk@musc.edu
Phone: (843)792-1901 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 21, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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