Status:
COMPLETED
Memory Reconsolidation Blockade as a Novel Intervention for Nicotine Dependence
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Smoking Cessation
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 eff...
Detailed Description
SPECIFIC AIMS 1. To evaluate, in current smokers, the efficacy of a single dose of study medication given an hour prior to smoking-related cue exposure (post-reactivation treatment) on psychophysiolo...
Eligibility Criteria
Inclusion
- Inclusion:
- Healthy smokers aged 18-65 who have smoked at least 10 cigarettes/day for the past 3 months
- Exclusion:
- Age \<18 or \>65
- Systolic blood pressure \<100 mm Hg;
- Medical condition that contraindicates the administration of propranolol, e.g., history of congestive heart failure, heart block, insulin-dependent diabetes, chronic bronchitis, emphysema, or asthma. With regard to asthma, because many persons who say they have had an asthma attack, especially as a child, may only have had hay fever, another allergy, or another non-asthmatic episode, a blanket exclusion criterion may be overly restrictive. Therefore, asthma attacks will only be exclusionary if they a.) occurred within the past ten years, b.) occurred at any time in life if induced by a B-blocker, or c.) are currently being treated, regardless of the date of last occurrence. Cardiological consultation will be obtained as necessary;
- Previous adverse reaction to, or non-compliance with, a B-blocker;
- Current use of medication that may involve potentially dangerous interactions with propranolol, including, other B-blockers, antiarrhythmics, or calcium channel blockers.
- Use of drugs of abuse other than nicotine or caffeine, such as opiates, marijuana, cocaine, or amphetamines, as determined by saliva or urine testing;
- Pregnancy (in women of child-bearing potential, a pregnancy test will be performed) or breast-feeding;
- Current PTSD, or psychotic, melancholic, or bipolar disorder
- Diagnosis of major depressive disorder in the past 6 months or HAM-D score \>15 at screening
- Current participation in any additional nicotine dependence treatment.
- An urgent need to stop smoking: subjects who receive placebo may not achieve optimal smoking cessation results.
- Inability to understand the study's procedures, risks, and side effects, or to otherwise give informed consent for participation;
- Subject candidate does not understand English
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00916721
Start Date
April 1 2008
End Date
January 1 2011
Last Update
September 19 2014
Active Locations (1)
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1
Massachusetts General Hospital - Center For Addiction Medicine
Boston, Massachusetts, United States, 02114