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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00830362 |
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 |
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
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Placebo: Placebo Comparator |
Drug: Placebo
administered once
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Tara Abbott, MA | 843-792-2286 | abbottt@musc.edu |
United States, South Carolina | |
Medical University of South Carolina | Recruiting |
Charleston, South Carolina, United States, 29425 |
Principal Investigator: | Michael Saladin, Ph.D. | Medical University of South Carolina |
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 |
cocaine cocaine-dependent propranolol craving beta-blockade |
cue exposure drug addiction memory addictive behavior |
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 |
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 |