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Beta-blockade Effects on Memory for Cocaine Craving
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), July 2009
First Received: January 26, 2009   Last Updated: July 24, 2009   History of Changes
Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00830362
  Purpose

The purpose of this study is to examine the effects of propranolol versus placebo on responses to cocaine cues in cocaine dependent individuals.


Condition Intervention Phase
Cocaine Dependence
Drug: Propranolol
Drug: Placebo
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Treatment Implications of Beta-blockade Effects on Memory for Cocaine Craving

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • drug craving and physiological arousal (heart rate, skin conductance, blood pressure) during cue exposure session [ Time Frame: during initial cue exposure session (same day as drug administration) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • drug craving and physiologic arousal (heart rate, skin conductance, blood pressure) during cue exposure session [ Time Frame: at one-week follow-up assessment (one week after drug administration) ] [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: February 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Propranolol 40mg: Active Comparator Drug: Propranolol
40 mg administered once
Placebo: Placebo Comparator Drug: Placebo
administered once

Detailed Description:

This study will employ cocaine-dependent individuals to investigate the acute effects of propranolol vs. placebo, administered immediately after a retrieval session of cocaine cue exposure, on the subjective and physiological responses occurring during a subsequent test session of cocaine cue exposure. Participants (N=52) will be randomly assigned to receive 40 mg propranolol or placebo immediately after the first of two cocaine cue exposure sessions scheduled to occur on consecutive days of an inpatient stay at MUSC's General Clinical Research Center (GCRC). The first session will serve as a retrieval session where cocaine cue exposure will putatively elicit retrieval and reconsolidation of memories about the association between the cues and cocaine administration; the second session of cocaine cue exposure will be a test session to examine the potential modulatory role of propranolol on the reconsolidated memories putatively elicited during the previous cue exposure session. It is assumed that changes in craving and physiological reactivity during the test session will reflect propranolol's effects on memory reconsolidation processes elicited by cue exposure during the retrieval session. Medications will be administered in a double-blind fashion. Craving and physiological arousal (heart rate, skin conductance, blood pressure) will be obtained at baseline and at regular intervals during and after both cue exposure sessions. Approximately 7 days following discharge from the inpatient stay at the GCRC, participants will return to the GCRC to undergo a 1-week follow-up cue exposure session that will be identical to the previous two sessions (no medications will be administered). The goal of the follow-up will be to examine if any craving and/or physiological reactivity differences identified during the test session were sustained and to assess if the groups differed in their cocaine use during the intervening 7-day period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current cocaine dependence (within past month)
  • Able to provide informed consent
  • Use of birth control by female participants (barrier methods, surgical sterilization, IUD, or abstinence)
  • Live within 50-mile radius of research site
  • Consent to remain abstinent from all drugs of abuse (except nicotine) for 24 hours prior to inpatient admission and follow-up assessment
  • Consent to random assignment to propranolol or placebo

Exclusion Criteria:

  • Women who are pregnant, nursing or are of childbearing potential and not practicing/using birth control
  • Evidence or history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal or neurological disease, including diabetes
  • Significant liver impairment
  • History of or current psychotic disorder, current major depressive disorder, bipolar affective disorder or a severe anxiety disorder
  • Currently taking anti-arrhythmic agents, psychostimulants or other agents known to interfere with heart rate and skin conductance monitoring
  • Known or suspected hypersensitivity to propranolol
  • Individuals taking medications that could adversely interact with the study medication, including, but not limited to albuterol, insulin, or significant inhibitors of CYP2D6
  • Individuals with bronchial asthma or chronic obstructive pulmonary disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830362

Contacts
Contact: Tara Abbott, MA 843-792-2286 abbottt@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Investigators
Principal Investigator: Michael Saladin, Ph.D. Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Medical University of South Carolina ( Michael Saladin, Ph.D. )
Study ID Numbers: 18285, 1 R21 DA025155-01, DPMC
Study First Received: January 26, 2009
Last Updated: July 24, 2009
ClinicalTrials.gov Identifier: NCT00830362     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):
cocaine
cocaine-dependent
propranolol
craving
beta-blockade
cue exposure
drug
addiction
memory
addictive behavior

Study placed in the following topic categories:
Cocaine-Related Disorders
Dopamine Uptake Inhibitors
Vasodilator Agents
Behavior, Addictive
Neurotransmitter Agents
Adrenergic Agents
Central Nervous System Depressants
Anesthetics
Disorders of Environmental Origin
Cardiovascular Agents
Antihypertensive Agents
Anesthetics, Local
Dopamine
Propranolol
Mental Disorders
Substance-Related Disorders
Vasoconstrictor Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Dopamine Agents
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Cocaine

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Vasodilator Agents
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Disorders of Environmental Origin
Anesthetics
Propranolol
Mental Disorders
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents
Substance-Related Disorders
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Cocaine
Cocaine-Related Disorders
Central Nervous System Depressants
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Anesthetics, Local
Adrenergic Antagonists
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 03, 2009