Mechanisms of Lorcaserin for Smoking Cessation

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Tobacco Use Disorder, Smoking Cessation

In brief

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 needed to identify medications with alternate pharmacological targets. Based on evidence that the serotonin system plays a role in nicotine consumption and relapse, this study will examine whether a selective serotonin medication alters smoking-related behaviors and responses to cigarette smoking under controlled conditions, informing its potential utility for smoking cessation.

Key facts

Study ID

NCT04396834

Run by

The Mind Research Network

People needed

3

Starts

2019-12-04

Expected to finish

2020-02-26

Last updated by the study team

2023-03-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Mind Research Network — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.