Effects of Propranolol on Responses to Drug-Related Imagery Scripts
Information source: National Institutes of Health Clinical Center (CC)
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cocaine Dependence
Intervention: Propranolol (Drug); Placebo (Drug)
Phase: Phase 1
Sponsored by: National Institute on Drug Abuse (NIDA)
Official(s) and/or principal investigator(s):
Kenzie Preston, Ph.D., Principal Investigator, Affiliation: National Institute on Drug Abuse (NIDA)
Kenzie Preston, Ph.D., Phone: (443) 740-2326, Email: email@example.com
- 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 sight of a crack pipe and a set of responses such as rapid heartbeat and
desire for cocaine. This type of memory is reconsolidated (actively re-stored) each
time it is reactivated; however, the reconsolidation process can be disrupted by the
drug propranolol, which weakens the link between that memory and an emotional response.
- Propranolol is traditionally used to treat high blood pressure and other heart-related
conditions. Researchers are interested in studying whether propranolol disrupts
reconsolidation of drug-cued memories in individuals who are addicted to cocaine.
- To examine whether propranolol can interfere with reconsolidation of cocaine-related
memories and reduce cravings and drug use in substance abusers.
- Individuals between 18 and 55 years of age who are current cocaine users enrolled in a
methadone treatment program.
- The study will involve four long sessions (visits 1, 4, 6, and 14) and 10 short
sessions. The short visits will be for monitoring of participants' use of drugs and
alcohol; the longer visits will involve more tests and lab sessions. Participants will
be randomized to either the propranolol or placebo group.
- The long sessions will involve the following procedures:
- An interview session to develop a personalized drug script/cue set.
- A two-hour intervention session with baseline measures, drug administration
(propranolol or placebo), and two script-guided imagery sets. This is the only
administration of propranolol during the study.
- Two follow-up test sessions, 1 and 5 weeks after the intervention session.
- Participants will make brief visits to our outpatient clinic for twice-weekly
monitoring of ongoing drug use via urine screens and self-report, starting 1 week
before the intervention session and ending 5 weeks later.
Official title: Effects of Propranolol on Responses to Drug-Related Imagery Scripts
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Basic Science
Primary outcome: Drug craving
Secondary outcome: Galvanic skin response
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, but in a sense that corresponds more closely to emotional associations-for example,
the association between the sight of a crack pipe and a set of responses such as rapid
heartbeat and desire for cocaine. Studies in rodents and humans show that this type of
memory is reconsolidated (actively re-stored) each time it is reactivated, and that the
reconsolidation process can be disrupted by propranolol. Such disruption does not erase the
autobiographical memory of an event, but instead weakens the link between that memory and an
emotional response. Human studies are needed to determine whether propranolol disrupts
reconsolidation of drug-cued memories in addicted individuals; this would present a novel
and exciting therapeutic possibility for preventing craving and relapse.
To examine whether administration of propranolol interferes with reconsolidation of
cocaine-related memories and reduces cravings and drug use in substance abusers.
Up to 200 (60 evaluable) individuals maintained on methadone and using cocaine will be
recruited from local treatment programs. The target enrollment will include 40% women and
Experimental design and methods
Participants will be randomized to one of two groups: propranolol (40 mg, oral,
immediate-release formulation) or placebo. The study will include four laboratory sessions:
(1) An information-gathering session that includes an interview to obtain information for
development of a personalized drug script/cue set. (2) A two-hour intervention session in
which there will be baseline measures, drug administration (propranolol or placebo, double
blind), and, starting 60 min after drug administration, two script-guided imagery sets.
Cue-responsivity data will be collected, but the main purpose of the session is
interventional. This will be the only administration of propranolol during the study. (3,
4) Two follow-up test sessions, 1 and 5 weeks after the intervention session; participants'
responses to re-exposure to the personalized drug script/cue set will be measured. In
addition to attending the four laboratory sessions, participants will make brief visits to
our outpatient clinic for twice-weekly monitoring of ongoing drug use via urine screens and
self-report, starting 1 week before the intervention session and ending 5 weeks later.
Outcome measures will include subjective ratings of drug craving, autonomic responses (heart
rate, blood pressure, galvanic skin response), and cocaine and heroin use (urine drug
screens and self-reported drug use).
Minimum age: 18 Years.
Maximum age: 55 Years.
- 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
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
6. - Pregnant; breast feeding.
7. - Impaired hepatic function with AST or ALT greater than 5x the upper limit of
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.
Locations and Contacts
Kenzie Preston, Ph.D., Phone: (443) 740-2326, Email: firstname.lastname@example.org
National Institute on Drug Abuse, Baltimore, Maryland 21224, United States; Recruiting
For more information contact Mathew's Media Group Recruiting, Phone: 800-535-8254, Email: email@example.com
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Starting date: December 2007
Last updated: June 28, 2012