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NCT00916721 · ClinicalTrials.gov registry record · Phase 3
Memory Reconsolidation Blockade as a Novel Intervention for Nicotine Dependence
A Phase 3 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 113
- Enrollment target
NCT00916721: Completed Phase 3 study, sponsored by Massachusetts General Hospital.
NCT00916721 is a Phase 3 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 113 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00916721, a Phase 3 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 113 participants
- Enrollment target
Study Summary
Smoking is the leading cause of preventable morbidity and mortality in the US. While approximately 70% of smokers attempt to quit each year, only 5-15% maintain abstinence for 12 months, even with effective pharmacological and psychological interventions. Novel therapies are needed for smoking cessation and relapse prevention. Previous studies show that early post-cessation craving or urge to smoke is a powerful predictor of relapse. A current model of the pathogenesis of addiction maintains that a substance of abuse causes a marked increase release in phasic dopamine release, which in turn strengthens or increases the salience of the memory of the drug experience, leading to a powerful and persistent memory that is easily activated, leading to drug craving and often to drug use. This highly salient memory is also implicated in the physiological arousal associated with craving responses to smoking cues. This process is thought to be implicated in relapse to drug use after even long periods of abstinence. Recent animal research indicates that retrieval returns a consolidated memory such as those associated with drug craving, to a labile state from which it must be restabilized to persist in a process termed reconsolidation. If memories of drug-related experiences are labile when reactivated, this could represent a window of opportunity in which the memory of drug use that underlies drug craving can be influenced pharmacologically. Our hypothesis is that post-reactivation administration of the B-adrenergic blocker, propranolol, following retrieval of drug-associated memories will reduce the strength or salience of the memory by influencing reconsolidation, a process called memory reconsolidation blockade. In this study we will test the hypothesis that a single dose of propranolol given one hour prior to smoking-related cue exposure (post-reactivation treatment) will decrease psychophysiological responses to smoking cues one week later and will predict clinical respons
Interventions
- DRUG Placebo
- DRUG Propranolol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2008-04 |
| Est. Completion | 2011-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00916721
The ClinicalTrials.gov registry entry for NCT00916721 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 113 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00916721 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00916721 about?
NCT00916721 is a clinical study titled "Memory Reconsolidation Blockade as a Novel Intervention for Nicotine Dependence". Smoking is the leading cause of preventable morbidity and mortality in the US. While approximately 70% of smokers attempt to quit each year, only 5-15% maintain abstinence for 12 months, even with effective pharmacological and psychological interventions. Novel therapies are needed for smoking cessa...
What is the current status of trial NCT00916721?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 113 participants. The study started on 2008-04. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00916721?
The interventions under investigation include: Placebo (DRUG), Propranolol (DRUG).
Who is sponsoring clinical trial NCT00916721?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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