Laboratory Screening of Lorcaserin for Alcohol Use Disorder

• Status: Terminated
• Trial end date: 2020-02-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Mind Research Network

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