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Laboratory Screening of Lorcaserin for Alcohol Use Disorder

Primary Purpose

Alcohol Use Disorder, Tobacco Smoking

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lorcaserin Oral Tablet
Placebo oral tablet
Sponsored by
The Mind Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcohol Use Disorder

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Mind Research Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lorcaserin first, then placebo

Placebo first, then lorcaserin

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Subjective Responses to Alcohol
Maximum self-reported stimulation during alcohol self-administration, as measured by the Brief Biphasic Alcohol Effects Scale. The final reported score is the sum of each item in the stimulation scale divided by the total number of items (3). The range of scores is 0-10, with higher numbers indicating higher subjective stimulation from alcohol.
Motivation to Consume Alcohol
Self-reported alcohol demand, as measured by elasticity in the Alcohol Purchase Task. Elasticity was computed according to Jacobs & Bickel (1999), using the estimated parameters a and b from the equation ln C = ln L + b(ln P) - aP, where C is number of drinks that would be consumed at price P, and L is a constant that represents the number of drinks consumed at P = 1. Overall elasticity is determined by computing elasticity (a-b(P)) for each price/consumption pair and taking the mean. Greater values of elasticity (i.e., less negative in this case) indicate increased willingness to consume the same number of drinks even as the price increases.
Motivation to Smoke Cigarettes
Self-reported cigarette demand, as measured by elasticity in the Cigarette Purchase Task. Elasticity was computed according to Jacobs & Bickel (1999), using the estimated parameters a and b from the equation ln C = ln L + b(ln P) - aP, where C is number of cigarettes that would be purchased at price P, and L is a constant that represents the number of cigarettes purchased at P = 1. Overall elasticity is determined by computing elasticity (a-b(P)) for each price/consumption pair and taking the mean. Greater values of elasticity (i.e., less negative in this case) indicate increased willingness to purchase the same number of cigarettes even as the price increases.
Daily Alcohol Consumption
Self-reported drinks per drinking day
Cigarette Consumption
Number of cigarettes smoked per day

Full Information

First Posted
February 3, 2020
Last Updated
August 16, 2022
Sponsor
The Mind Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT04396847
Brief Title
Laboratory Screening of Lorcaserin for Alcohol Use Disorder
Official Title
Human Laboratory Screening of Lorcaserin in Smokers With Alcohol Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Medication removed from the U.S. market by the The Food and Drug Administration
Study Start Date
October 25, 2019 (Actual)
Primary Completion Date
February 26, 2020 (Actual)
Study Completion Date
February 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Mind Research Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Tobacco Smoking

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lorcaserin first, then placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo first, then lorcaserin
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lorcaserin Oral Tablet
Other Intervention Name(s)
Belviq
Intervention Description
Lorcasering 10mg Oral Tablet (BID)
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Other Intervention Name(s)
Placebo pill
Intervention Description
Placebo Oral Tablet (BID)
Primary Outcome Measure Information:
Title
Laboratory Alcohol Consumption
Description
Number of drinks consumed during a 2-hour alcohol self-administration session
Time Frame
Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills.
Secondary Outcome Measure Information:
Title
Subjective Responses to Alcohol
Description
Maximum self-reported stimulation during alcohol self-administration, as measured by the Brief Biphasic Alcohol Effects Scale. The final reported score is the sum of each item in the stimulation scale divided by the total number of items (3). The range of scores is 0-10, with higher numbers indicating higher subjective stimulation from alcohol.
Time Frame
Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills
Title
Motivation to Consume Alcohol
Description
Self-reported alcohol demand, as measured by elasticity in the Alcohol Purchase Task. Elasticity was computed according to Jacobs & Bickel (1999), using the estimated parameters a and b from the equation ln C = ln L + b(ln P) - aP, where C is number of drinks that would be consumed at price P, and L is a constant that represents the number of drinks consumed at P = 1. Overall elasticity is determined by computing elasticity (a-b(P)) for each price/consumption pair and taking the mean. Greater values of elasticity (i.e., less negative in this case) indicate increased willingness to consume the same number of drinks even as the price increases.
Time Frame
Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills.
Title
Motivation to Smoke Cigarettes
Description
Self-reported cigarette demand, as measured by elasticity in the Cigarette Purchase Task. Elasticity was computed according to Jacobs & Bickel (1999), using the estimated parameters a and b from the equation ln C = ln L + b(ln P) - aP, where C is number of cigarettes that would be purchased at price P, and L is a constant that represents the number of cigarettes purchased at P = 1. Overall elasticity is determined by computing elasticity (a-b(P)) for each price/consumption pair and taking the mean. Greater values of elasticity (i.e., less negative in this case) indicate increased willingness to purchase the same number of cigarettes even as the price increases.
Time Frame
Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills.
Title
Daily Alcohol Consumption
Description
Self-reported drinks per drinking day
Time Frame
During 7 days of medication or during 7 days of placebo pills.
Title
Cigarette Consumption
Description
Number of cigarettes smoked per day
Time Frame
During 7 days of medication or during 7 days of placebo pills.

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Hendershot, Ph.D.
Organizational Affiliation
The Mind Research Network
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Claus, Ph.D.
Organizational Affiliation
The Mind Research Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Mind Research Network
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Laboratory Screening of Lorcaserin for Alcohol Use Disorder

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