Status:
COMPLETED
A Placebo-Controlled Double-Blind Combined Treatment of Modafinil and CBT for Cocaine Dependence
Lead Sponsor:
Research Foundation for Mental Hygiene, Inc.
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Dependence
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test whether a cognitive behavioral therapy (CBT) and a medication called modafinil, which is approved to treat sleep disorders, will help individuals who are abusing c...
Detailed Description
Chronic cocaine abuse has been documented to produce cognitive impairments in various domains. The observed cognitive deficits in the substance abuse population include, but are not restricted to, att...
Eligibility Criteria
Inclusion
- Meets DSM IV criteria for current cocaine dependence and is seeking treatment.
- Used cocaine at least eight days in the past month or reports episodic binges of large amounts of cocaine (at least $150 worth) at least twice per month
- Able to give informed consent and comply with study procedures.
Exclusion
- Meets DSM IV criteria for current mood disorder or past or current mania (i.e. bipolar disorder), schizophrenia or any psychotic disorder other than transient psychosis due to drug abuse.
- Baseline 21 item Hamilton Depression Scale scores ≥ 15
- History of seizures
- Chronic organic mental disorder.
- Significant current suicidal risk.
- Pregnancy, lactation, or failure in sexually active female participants to use adequate contraceptive methods.
- Unstable physical disorders, which might make participation hazardous such as hypertension, hepatitis, participants with mildly elevated AST and ALT levels (\< 3 X upper limit or normal are acceptable), or diabetes.
- Coronary vascular disease as indicated by history, or suspected by abnormal EKG or history of cardiac symptoms.
- Current use of prescribed psychotropic medications.
- Current use of medications that interact with modafinil: Tricyclic anti-depressants; MOA Inhibitors; diazepam; phenytoin and medications containing Ethinyl Estradiol
- Known hypersensitivity to modafinil
- Currently meets DSM-IV criteria for narcolepsy
- Currently meets DSM-IV criteria for ADHD
- Currently meets DSM-IV criteria for opioid or sedative-hypnotic dependence.
- Currently meets criteria for DSM-IV alcohol dependence with evidence of clinically significant physiological dependence in need of medically supervised detoxification.
- Current cannabis dependence is identified as the main problem-i.e. participants with current DSM-IV cannabis dependence are eligible, as long as cocaine is identified by the participant as the primary substance problem for which they are seeking treatment.
- Gross visual or auditory impairments
- First language is not English and received NO formal education in English-speaking school
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00344565
Start Date
November 1 2005
End Date
March 1 2007
Last Update
December 3 2012
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