Laboratory Screening of Lorcaserin for Alcohol Use Disorder
Condition: Alcohol Use Disorder; Tobacco Smoking
MeSH terms: Alcoholism; Alcohol Drinking
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: 5.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Heavy-drinking smokers, including those with alcohol use disorder (AUD), are at increased
      risk for numerous negative health outcomes relative to those who use alcohol or cigarettes
      only. Although heavy-drinking smokers are recognized as an important subgroup for clinical
      and public health interventions, there are presently no approved medications for the joint
      indication of alcohol reduction and smoking cessation. Based on evidence that the serotonin
      system plays a role in alcohol and nicotine consumption and relapse, this study aims to
      examine whether a serotonin medication alters alcohol and nicotine responses in smokers with
      AUD, informing its potential utility as a candidate therapy for this clinical subgroup.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 21-65

          2. Meeting DSM-5 criteria for current (past year) AUD, as well as current at-risk
             drinking (i.e., ≥14/21 drinks per week for women/men, on average), with at least four
             episodes of 4+/5+ drinks in the past 30 days

          3. Daily smoker, defined as reporting smoking 1+ cigarettes per day, on average, over the
             past 12 months

          4. Willingness to take study pills and complete study procedures

          5. Willingness to complete lab sessions involving alcohol administration

        Exclusion Criteria:

          1. Recent (30 day) illicit drug use (with the exception of cannabis) based on self-report
             or toxicology screen

          2. Meeting DSM-5 criteria for a past-year substance use disorder other than alcohol use
             disorder, tobacco use disorder, or mild cannabis use disorder

          3. Significant alcohol withdrawal, based on a Clinical Institute Withdrawal Assessment
             for Alcohol-revised (CIWA-Ar) score of 8+ at baseline medical visit, or any reported
             history of severe withdrawal symptoms (e.g., seizures)

          4. Past 30-day use of nicotine replacement

          5. Past 30-day use of SSRIs, other psychiatric medications, or weight control medications

          6. Lifetime diagnosis of severe mental illness (e.g., psychotic or bipolar I disorder)

          7. Significant medical or neurological illness based on medical staff (i.e., physician or
             nurse practitioner) evaluation including severe hepatic impairment or cirrhosis,
             insulin dependent diabetes

          8. Current alcohol or smoking cessation treatment or efforts to cut down on
             drinking/smoking

          9. Medications contraindicated for use with lorcaserin or which have a significant
             interaction with lorcaserin

         10. Body mass index (BMI) under normal range (<18kg/m2)

         11. History of significant cardiovascular conditions including history of arrhythmias or
             heart block, heart failure, valvular heart disease, heat attack, stroke, unstable
             angina

         12. Abnormal electrocardiogram (ECG) results

         13. Currently nursing, pregnant, or anticipating pregnancy

         14. history of suicide attempt or recent suicidal ideation (i.e., 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