Effects of Propranolol on Responses to Drug-Related Imagery Scripts

• Register: ClinicalTrials.gov
• Last refreshed on: 25 March 2013
• Main ID: NCT00688805
• Date of registration: 30/05/2008
• Primary sponsor: National Institute on Drug Abuse (NIDA)
• Public title: Effects of Propranolol on Responses to Drug-Related Imagery Scripts
• Scientific title: Effects of Propranolol on Responses to Drug-Related Imagery Scripts
• Date of first enrolment: December 2007
• Target sample size: 200
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00688805
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Basic Science

Countries of recruitment

United States

Contacts

• Name: Kenzie Preston, Ph.D.
• Affiliation: National Institute on Drug Abuse (NIDA)

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cocaine Dependence

Intervention(s)

Drug: Placebo

Drug: Propranolol

Primary Outcome(s)

Drug craving [Time Frame: 1 hr]

Secondary Outcome(s)

Galvanic skin response [Time Frame: 1 hr]

Secondary ID(s)

08-DA-N433

999908433

Source(s) of Monetary Support

Please refer to primary and secondary sponsors