This study evaluates the efficacy of propranolol and amantadine in patients with severe
cocaine withdrawal and cocaine craving.
Inclusion Criteria:
- Male and females, 18 to 60 years old.
- Meets DSM-IV criteria for Cocaine Dependence, as determined by the Structured Clinical
Interview for DSM-IV (SCID).
- Initial CSSA score of 22 or greater. This score would place patients at risk of early
treatment attrition and inability to attain abstinence based on previous cocaine
pharmacotherapy trials conducted at this center.
- Continued use of cocaine during a two week evaluation phase prior to medication
treatment as demonstrated by at least 2 new uses of cocaine documented by quantitative
urine toxicology screen obtained every M, W, F according to new use rules (Preston et
al., 1997).
- Live within a commutable distance of the Treatment Research Center (TRC) at the
Penn/VA Center for Studies of Addiction, University of Pennsylvania. We define this
to be a distance within the service area of Septa, within an hour drive, or a distance
that both the patient and Principal Investigator (PI) find acceptable .
- Understands and signs the informed consent.
Exclusion Criteria:
- Current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine,
marijuana, or nicotine dependence, as determined by the SCID.
- Concomitant treatment with psychotropic medications.
- Patients mandated to treatment based upon a legal decision or as a condition of
employment.
This will be assessed by the patient's self-report.
- Current severe psychiatric symptoms, e. g., psychosis, dementia, suicidal or homicidal
ideation, mania or depression requiring antidepressant therapy in the opinion of the
Principal Investigator (PI).
- Use of any investigational medication within the past 30 days.
- History of significant heart disease (an arrhythmia which required medication,
Wolff-Parkinson - White Syndrome, angina pectoris, documented history of myocardial
infarction, heart failure).
- History of chest pain associated with cocaine use which has prompted a visit to a
physician.
- Current use of reserpine, verapamil, theophylline, trimethoprim, cimetidine,
haloperidol, benzodiazepines, or anticonvulsants.
- Patients with bronchospastic disease, hyperthyroidism, diabetes mellitus.
- Known hypersensitivity to propranolol or amantadine.
- Patients with known AIDS or other serious illnesses which may require hospitalization
during the study.
- Female subjects who are pregnant or lactating, or female subjects of child bearing
potential who are not using acceptable methods of birth control. Acceptable methods
of birth control include: barrier (diaphragm or condom) with spermicide,
intrauterine progesterone contraceptive system, levonorgestrel implant,
medroxyprogesterone acetate contraceptive injection, oral contraceptives.
- Patients with impaired renal function as indicated by corrected creatinine clearance
below 80 ml/min/70 kg as determined by the modified Cockcroft equation (CDC, 1986).
- Clinical laboratory tests (CBC, blood chemistries, urinalysis) outside normal limits
that are clinically unacceptable to the Principal Investigator. EKG?1st degree heart
block, sinus tachycardia, left axis deviation, and nonspecific ST or T wave changes
are allowed; liver function tests [LFTs] <5 x ULN are acceptable).
