A Placebo-Controlled Double-Blind Combined Treatment of Modafinil and CBT for Cocaine Dependence

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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 cocaine.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Research Foundation for Mental Hygiene, Inc.
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Armodafinil; Cocaine; Modafinil

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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