Status:
TERMINATED
Mechanisms of Lorcaserin for Smoking Cessation
Lead Sponsor:
The Mind Research Network
Conditions:
Tobacco Use Disorder
Smoking Cessation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Identifying new medication options is critical for curbing the health burdens of cigarette smoking. Currently approved smoking cessation medications act on nicotinic receptors, and additional work is ...
Detailed Description
Tobacco use remains the foremost cause of preventable deaths in the U.S. and worldwide. Advancing new smoking cessation therapies, including those with novel pharmacological targets, is a critical pub...
Eligibility Criteria
Inclusion
- age 18-65
- smoking 5+ cigarettes per day (average) over the past year, with no period of abstinence \> 90 days
- biochemical verification of smoking status
- at least low to moderate nicotine dependence
- reporting long-term motivation to quit smoking
- willingness to take study pills and complete study procedures
- willingness to complete lab sessions involving cigarette smoking
Exclusion
- meeting DSM-5 criteria for substance use disorder aside from tobacco use disorder and mild cannabis use disorder
- recent (30 day) illicit drug use (except marijuana), based on self-report and urine drug screen
- past 30-day use of tobacco cessation aids or nicotine/tobacco products other than cigarettes
- past 30-day use of SSRIs, other psychiatric medications, or weight control medications
- lifetime diagnosis of severe mental illness (e.g., psychotic or bipolar I disorder)
- significant medical or neurological illness, including severe hepatic impairment or cirrhosis, or insulin dependent diabetes
- actively engaged in smoking cessation treatments or a smoking cessation attempt (or intent to start an attempt in the next 90 days)
- interested in quitting smoking immediately (i.e., in the next two months)
- Medications contraindicated for use with lorcaserin or which have a significant interaction with lorcaserin
- body mass index (BMI) under normal range (BMI \< 18 kg/m2)
- history of significant cardiovascular conditions including history of arrhythmias or heart block, heart failure, valvular heart disease, heart attack, stroke, unstable angina
- abnormal electrocardiogram (ECG) results
- nursing, pregnant, or anticipating pregnancy
- history of suicide attempt or recent suicidal thoughts (intent or plan) in the last month
- Plans to travel outside of the local area during the study period, or inability to commit to entire duration of study
Key Trial Info
Start Date :
December 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2020
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04396834
Start Date
December 4 2019
End Date
February 26 2020
Last Update
March 20 2023
Active Locations (1)
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1
The Mind Research Network
Albuquerque, New Mexico, United States, 87106