Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-24 @ 9:45 PM
NCT ID:
NCT00158132
Eligibility Criteria:
Inclusion Criteria:
* Male and females, 18 to 60 years old.
* Meets DSM-IV diagnosis criteria for cocaine dependence as determined by the Structured Clinical Interview for DSM-IV (SCID)
* Score of at least (\> or =) 22 on the Initial Cocaine Selective Severity Assessment (CSSA)
* Lives within commuting distance of the Treatment Research Center (TRC) and the Penn/VA Center for Studies of Addiction, University of Pennsylvania
* If female, willing to use contraception throughout the study
* 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 three times weekly according to new use rules
Exclusion Criteria:
* Meets DSM-IV/SCID diagnosis criteria for dependence on any drugs other than cocaine, marijuana, or nicotine. Cocaine dependent subjects who identify cocaine dependence as their primary addiction but who also meet criteria for alcohol dependence will be accepted as long as the alcohol dependence is not severe enough to require medications for alcohol detoxification.
* 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 medication)
* Sensitivity to propranolol or amantadine
* 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
* Bronchospastic disease
* Hyperthyroidism
* Diabetes mellitus
* 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:
1. barrier (diaphragm or condom) with spermicide
2. intrauterine progesterone contraceptive system
3. levonorgestrel implant
4. medroxyprogesterone acetate contraceptive injection
5. 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). A complete list of exclusionary lab results are included in the appendix 1
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00158132
Study Brief:
Protocol Section:
NCT00158132