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| Sponsor: | Medical University of South Carolina |
|---|---|
| Collaborator: |
National Institute on Drug Abuse (NIDA) |
| Information provided by (Responsible Party): | Medical University of South Carolina |
| 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: | 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 |
| 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
|
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:
Exclusion Criteria:
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
| 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: | September 29, 2011 |
| 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 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 |