Beta-blockade Effects on Memory for Cocaine Craving
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Treatment Implications of Beta-blockade Effects on Memory for Cocaine Craving |
- 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 ]
- 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 ]
- amount of cocaine use (in dollars) in days between the testing visit and the one week follow-up visit [ Time Frame: measured at one-week follow-up visit ] [ Designated as safety issue: No ]The amount of cocaine used between the testing visit and the one-week follow-up visit will be recorded using dollar amounts to preliminarily evaluate group differences in cocaine use.
| Enrollment: | 50 |
| Study Start Date: | February 2009 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Propranolol 40mg |
Drug: Propranolol
40 mg administered once
|
| Placebo Comparator: Placebo |
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 |
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
Contacts and Locations| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| Principal Investigator: | Michael Saladin, Ph.D. | Medical University of South Carolina |
More Information
No publications provided
| Responsible Party: | Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT00830362 History of Changes |
| Other Study ID Numbers: | 18285, R21DA025155, R21DA025155-01, DPMC |
| Study First Received: | January 26, 2009 |
| Last Updated: | March 26, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Medical University of South Carolina:
|
cocaine cocaine-dependent propranolol craving beta-blockade |
cue exposure drug addiction memory addictive behavior |
Additional relevant MeSH terms:
|
Cocaine-Related Disorders Substance-Related Disorders Mental Disorders Cocaine Propranolol Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors |
Physiological Effects of Drugs Anesthetics, Local Anesthetics Central Nervous System Depressants Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Anti-Arrhythmia Agents Antihypertensive Agents Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Vasodilator Agents |
ClinicalTrials.gov processed this record on October 18, 2012
