Laboratory Screening of Lorcaserin for Alcohol Use Disorder

NCT ID: NCT04396847

Last Updated: 2022-09-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-25
• Study Completion Date: 2020-02-26

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.

Detailed Description

Pharmacotherapy development remains a critical objective for reducing health and societal burdens associated with alcohol use disorder (AUD). Developing targeted treatments for specific AUD subgroups is a key objective. Among those with AUD, cigarette smokers comprise a sizable and critical subgroup with disproportionally high long-term health risks, making it a key priority to advance therapies for concurrent AUD and cigarette smoking. The serotonin (5-hydroxtytryptamine; 5-HT) system is broadly implicated in addictive behaviors, in part reflecting the role of 5-HT in modulating dopamine function. Preclinical studies of 5-HT receptor drugs have shown that targeted modulation of the 5-HT2C receptor (implicated in 5-HT-related inhibition of DA function) alters the consumption and reinstatement of addictive drugs, including alcohol and nicotine. Of the selective 5-HT2C receptor agonists, lorcaserin has superior near-term potential for repurposing as an AUD therapy, having been approved by the Food and Drug Administration for weight management. Human laboratory medication trials offer a time- and cost-effective option for validating preclinical findings prior to larger randomized controlled trials, and for testing candidate treatment mechanisms. This Phase II human laboratory screening trial will evaluate lorcaserin as a novel candidate therapy for smokers with AUD. Effects of lorcaserin vs. placebo will be evaluated in a double-blind, within-subjects, crossover study with human laboratory endpoints. This study will provide early human data on the effects of a 5-HT2C receptor agonist in relation to alcohol-related outcomes, informing its potential for further evaluation as a candidate treatment for AUD.

Conditions

Alcohol Use Disorder; Tobacco Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Lorcaserin first, then placebo

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.

Group Type: EXPERIMENTAL

Lorcaserin Oral Tablet

Intervention Type: DRUG

Lorcasering 10mg Oral Tablet (BID)

Placebo first, then lorcaserin

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.

Group Type: PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type: DRUG

Placebo Oral Tablet (BID)

Interventions

Lorcaserin Oral Tablet

Lorcasering 10mg Oral Tablet (BID)

Intervention Type: DRUG

Placebo oral tablet

Placebo Oral Tablet (BID)

Intervention Type: DRUG

Other Intervention Names

Belviq; Placebo pill

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Mind Research Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Hendershot, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Mind Research Network

Eric Claus, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Mind Research Network

Locations

The Mind Research Network

Albuquerque, New Mexico, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

04719

Identifier Type: -

Identifier Source: org_study_id