Beta-blockade Effects on Memory for Cocaine Craving

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00830362
Recruitment Status : Completed
First Posted : January 27, 2009
Results First Posted : November 30, 2012
Last Update Posted : November 30, 2012
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Medical University of South Carolina

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

Condition or disease Intervention/treatment Phase
Cocaine Dependence Drug: Propranolol Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment Implications of Beta-blockade Effects on Memory for Cocaine Craving
Study Start Date : February 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Active Comparator: Propranolol 40mg Drug: Propranolol
40 mg administered once

Placebo Comparator: Placebo Drug: Placebo
administered once

Primary Outcome Measures :
  1. Single Item Craving Test Session Difference Scores [ Time Frame: Both days of cue exposure ]
    Mean of the difference of Session 1 and Session 2 cocaine craving scores (Session 2-Session 1). Found by using our Single Item Craving (SIC) scale. A study team member asks the participant to verbally report the level of craving they were experiencing using values between 0 and 100, with 0 representing no craving and 100 extreme craving. The difference score was found by subtracting session 1 mean SICs during cue exposure from session 2 mean SICs during cue exposure. Therefore the mean of the difference could have ranged anywhere from -100 to 100. Negative mean difference scores reflect a decrease in craving for cocaine from session 1 (test) to session 2 (retrieval). The lower the mean difference score, the greater the decrease in craving.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • Significant liver impairment
  • History of or current psychotic disorder, current severe 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00830362

United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
Principal Investigator: Michael Saladin, Ph.D. Medical University of South Carolina

Responsible Party: Medical University of South Carolina Identifier: NCT00830362     History of Changes
Other Study ID Numbers: 18285
R21DA025155 ( U.S. NIH Grant/Contract )
R21DA025155-01 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
First Posted: January 27, 2009    Key Record Dates
Results First Posted: November 30, 2012
Last Update Posted: November 30, 2012
Last Verified: September 2012

Keywords provided by Medical University of South Carolina:
cue exposure
addictive behavior

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents