Status:
TERMINATED
Effects of Propranolol on Responses to Drug-Related Imagery Scripts
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Dependence
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Background: * Relapse to drug abuse is thought to result, in many cases, from exposure to cues that trigger drug-related memories or emotional associations for example, the association between the si...
Detailed Description
Background Relapse to drug abuse or addiction is thought to result, in many cases, from exposure to cues that elicit drug-related memories. The term memories is used here not in its everyday sense, b...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- \- Age between 18 and 55 years
- \- Evidence of current cocaine use (self-report)
- \- Minimum lifetime cocaine use of one year (self-report)
- \- Minimum use of cocaine of once in the past 30 days (self-report)
- \- Enrolled in methadone maintenance
- EXCLUSION CRITERIA:
- \- Allergy or hypersensitivity to propranolol or other beta blockers.
- \- History of: schizophrenia (or of any other DSM-IV psychotic disorder), anxiety disorders (e.g., panic disorder), or bipolar disorder.
- \- Current major depressive disorder.
- \- Current physical dependence on, or current abuse of, alcohol, benzodiazepines, or other sedative-hypnotic drugs.
- \- Cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires.
- \- Pregnant; breast feeding.
- \- Impaired hepatic function with AST or ALT greater than 5x the upper limit of normal.
- \- 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.
- \- Bradycardia (heart rate \< 60 bpm) on three consecutive readings.
- \- Systolic blood pressure \< 100 mm Hg; diastolic blood pressure \< 60 mm Hg; on three consecutive readings.
- \- 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.
- \- Current use of beta blockers for any medical condition.
Exclusion
Key Trial Info
Start Date :
December 12 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00688805
Start Date
December 12 2007
End Date
December 16 2013
Last Update
December 17 2019
Active Locations (1)
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1
National Institute on Drug Abuse
Baltimore, Maryland, United States, 21224