Mechanisms of Lorcaserin for Smoking Cessation
Condition: Tobacco Use Disorder; Smoking Cessation
MeSH terms: Tobacco Use Disorder
Intervention: Lorcaserin Oral Tablet; Placebo oral tablet
Intervention description: Lorcasering 10mg Oral Tablet (BID); Placebo Oral Tablet (BID)
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

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 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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. age 18-65

          2. smoking 5+ cigarettes per day (average) over the past year, with no period of
             abstinence > 90 days

          3. biochemical verification of smoking status

          4. at least low to moderate nicotine dependence

          5. reporting long-term motivation to quit smoking

          6. willingness to take study pills and complete study procedures

          7. willingness to complete lab sessions involving cigarette smoking

        Exclusion Criteria:

          1. meeting DSM-5 criteria for substance use disorder aside from tobacco use disorder and
             mild cannabis use disorder

          2. recent (30 day) illicit drug use (except marijuana), based on self-report and urine
             drug screen

          3. past 30-day use of tobacco cessation aids or nicotine/tobacco products other than
             cigarettes

          4. past 30-day use of SSRIs, other psychiatric medications, or weight control medications

          5. lifetime diagnosis of severe mental illness (e.g., psychotic or bipolar I disorder)

          6. significant medical or neurological illness, including severe hepatic impairment or
             cirrhosis, or insulin dependent diabetes

          7. actively engaged in smoking cessation treatments or a smoking cessation attempt (or
             intent to start an attempt in the next 90 days)

          8. interested in quitting smoking immediately (i.e., in the next two months)

          9. Medications contraindicated for use with lorcaserin or which have a significant
             interaction with lorcaserin

         10. body mass index (BMI) under normal range (BMI < 18 kg/m2)

         11. history of significant cardiovascular conditions including history of arrhythmias or
             heart block, heart failure, valvular heart disease, heart attack, stroke, unstable
             angina

         12. abnormal electrocardiogram (ECG) results

         13. nursing, pregnant, or anticipating pregnancy

         14. history of suicide attempt or recent suicidal thoughts (intent or plan) in the last
             month

         15. Plans to travel outside of the local area during the study period, or inability to
             commit to entire duration of study