Laboratory Screening of Lorcaserin for Alcohol Use Disorder

NCT04396847 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 04719
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Use Disorder; Tobacco Smoking

Outcome Measures

Primary Outcomes (1)

• Laboratory Alcohol Consumption

  Number of drinks consumed during a 2-hour alcohol self-administration session

  Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills.

Secondary Outcomes (5)

• Subjective Responses to Alcohol

  Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills

• Motivation to Consume Alcohol

  Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills.

• Motivation to Smoke Cigarettes

  Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills.

• Daily Alcohol Consumption

  During 7 days of medication or during 7 days of placebo pills.

• Cigarette Consumption

  During 7 days of medication or during 7 days of placebo pills.

Study Arms (2)

Lorcaserin first, then placebo

EXPERIMENTAL

Participants first receive lorcaserin (10 mg BID) for 7 days. After a washout period of 7 days, they then receive placebo tablets (BID) for 7 days.

Drug: Lorcaserin Oral Tablet

Placebo first, then lorcaserin

PLACEBO COMPARATOR

Participants first receive placebo (BID) for 7 days. After a washout period of 7 days, they then receive lorcaserin (10 mg BID) for 7 days.

Drug: Placebo oral tablet

Interventions

Lorcaserin Oral Tablet DRUG

Lorcasering 10mg Oral Tablet (BID)

Also known as: Belviq

Lorcaserin first, then placebo

Placebo oral tablet DRUG

Placebo Oral Tablet (BID)

Also known as: Placebo pill

Placebo first, then lorcaserin

Eligibility Criteria

• Age: 21 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-65
• 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
• Daily smoker, defined as reporting smoking 1+ cigarettes per day, on average, over the past 12 months
• Willingness to take study pills and complete study procedures
• Willingness to complete lab sessions involving alcohol administration

You may not qualify if:

• Recent (30 day) illicit drug use (with the exception of cannabis) based on self-report or toxicology screen
• Meeting DSM-5 criteria for a past-year substance use disorder other than alcohol use disorder, tobacco use disorder, or mild cannabis use disorder
• 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)
• Past 30-day use of nicotine replacement
• 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 based on medical staff (i.e., physician or nurse practitioner) evaluation including severe hepatic impairment or cirrhosis, insulin dependent diabetes
• Current alcohol or smoking cessation treatment or efforts to cut down on drinking/smoking
• Medications contraindicated for use with lorcaserin or which have a significant interaction with lorcaserin
• Body mass index (BMI) under normal range (\<18kg/m2)
• History of significant cardiovascular conditions including history of arrhythmias or heart block, heart failure, valvular heart disease, heat attack, stroke, unstable angina
• Abnormal electrocardiogram (ECG) results
• Currently nursing, pregnant, or anticipating pregnancy
• history of suicide attempt or recent suicidal ideation (i.e., 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

Sponsors & Collaborators

• The Mind Research Network: lead

Study Sites (1)

The Mind Research Network

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Alcoholism; Tobacco Smoking

Interventions

lorcaserin

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Smoking; Behavior; Tobacco Use

Results Point of Contact

• Title: Christian Hendershot
• Organization: UNC-Chapel Hill

christian_hendershot@med.unc.edu

(919) 962-5565

Study Officials

• Christian Hendershot, Ph.D.

  The Mind Research Network

  PRINCIPAL INVESTIGATOR

• Eric Claus, Ph.D.

  The Mind Research Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: May 21, 2020
• Study Start: October 25, 2019
• Primary Completion: February 26, 2020
• Study Completion: February 26, 2020
• Last Updated: September 7, 2022
• Results First Posted: September 7, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)