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:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT00688805
Eligibility Criteria:
* INCLUSION CRITERIA:
1. \- Age between 18 and 55 years
2. \- Evidence of current cocaine use (self-report)
3. \- Minimum lifetime cocaine use of one year (self-report)
4. \- Minimum use of cocaine of once in the past 30 days (self-report)
5. \- Enrolled in methadone maintenance
EXCLUSION CRITERIA:
1. \- Allergy or hypersensitivity to propranolol or other beta blockers.
2. \- History of: schizophrenia (or of any other DSM-IV psychotic disorder), anxiety disorders (e.g., panic disorder), or bipolar disorder.
3. \- Current major depressive disorder.
4. \- Current physical dependence on, or current abuse of, alcohol, benzodiazepines, or other sedative-hypnotic drugs.
5. \- Cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires.
6. \- Pregnant; breast feeding.
7. \- Impaired hepatic function with AST or ALT greater than 5x the upper limit of normal.
8. \- Medical conditions that would contraindicate administration of propranolol (e.g., uncompensated congestive heart failure; pulmonary edema; asthma; COPD; history of severe allergic reactions (seasonal, environmental, food, medications, etc.); Raynaud s disease; second- or third-degree atrioventricular block; arrhythmias other than sinus arrhythmia; thyroid dysfunction; diabetes mellitus; renal impairment.
Per the American Thoracic Society (ATS), COPD Clinical assessment is based on medical history and physical examination. Although a complete examination is indicated for all patients, these two components are specifically important for patients with suspected COPD. (ATS \& ERS, 2004) Accordingly, if medical history and physical exam suggest possible COPD the participant will be forwarded for spirometry/pulmonary function tests to aid in the diagnosis.
9. \- Bradycardia (heart rate \< 60 bpm) on three consecutive readings.
10. \- Systolic blood pressure \< 100 mm Hg; diastolic blood pressure \< 60 mm Hg; on three consecutive readings.
11. \- Medications that could interact with propranolol either pharmacodynamically or pharmacokinetically to produce adverse effects. Such medication would include CNS depressants (e.g., barbiturates, benzodiazepines, other sedatives), antihypertensive medications (including nitrates), antiarrhythmic medications, antiseizure medications (dilantin), acetylcholinesterase inhibitors (e.g., donepezil, galantamine), aminoquinolines (antimalarial), antipsychotic medications, beta agonists, insulin, MAOIs, NSAIDs, rifamycin derivatives, rizatriptan, SSRIs, sulfonylureas, theophylline, pseudophedrine, phenylephrine, ephedrine, epinephrine, noriepinephrine, amphetamines, and some herbal supplements.
12. \- Current use of beta blockers for any medical condition.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00688805
Study Brief:
Protocol Section:
NCT00688805