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Laboratory Screening of Lorcaserin for Alcohol Use Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04396847
Recruitment Status : Terminated (Medication removed from the U.S. market by the The Food and Drug Administration)
First Posted : May 21, 2020
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
The Mind Research Network

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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Tobacco Smoking Drug: Lorcaserin Oral Tablet Drug: Placebo oral tablet Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Human Laboratory Screening of Lorcaserin in Smokers With Alcohol Use Disorder
Actual Study Start Date : October 25, 2019
Actual Primary Completion Date : February 26, 2020
Actual Study Completion Date : February 26, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol
Drug Information available for: Lorcaserin

Arm Intervention/treatment
Experimental: Lorcaserin
Lorcaserin (10mg BID)
Drug: Lorcaserin Oral Tablet
Lorcasering 10mg Oral Tablet (BID)
Other Name: Belviq

Placebo Comparator: Placebo
Placebo pill (BID)
Drug: Placebo oral tablet
Placebo Oral Tablet (BID)
Other Name: Placebo pill




Primary Outcome Measures :
  1. Laboratory alcohol consumption [ Time Frame: Laboratory session following 7 days of medication vs. laboratory session following 7 days of placebo pills (difference score between sessions). ]
    Number of drinks consumed during a 2-hour alcohol self-administration session


Secondary Outcome Measures :
  1. Subjective responses to alcohol [ Time Frame: Laboratory session following 7 days of medication vs. laboratory session following 7 days of placebo pills (difference score between sessions). ]
    Self-reported stimulation and self-reported sedation during alcohol self-administration, as measured by the Biphasic Alcohol Effects Scale Scores for stimulation and sedation range from 0 to 10.

  2. Motivation to consume alcohol [ Time Frame: Laboratory session following 7 days of medication vs. laboratory session following 7 days of placebo pills (difference score between sessions). ]
    Self-reported alcohol demand, as measured by the Alcohol Purchase Task

  3. Motivation to smoke cigarettes [ Time Frame: Laboratory session following 7 days of medication vs. laboratory session following 7 days of placebo pills (difference score between sessions). ]
    Self-reported cigarette demand, as measured by the Cigarette Purchase Task

  4. Daily alcohol consumption [ Time Frame: During 7 days of medication vs. during 7 days of placebo pills (difference score between weeks). ]
    Self-reported drinks per drinking day

  5. Cigarette consumption [ Time Frame: During 7 days of medication vs. during 7 days of placebo pills (difference score between weeks). ]
    Number of cigarettes smoked per day



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04396847


Locations
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United States, New Mexico
The Mind Research Network
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
The Mind Research Network
Investigators
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Principal Investigator: Christian Hendershot, Ph.D. The Mind Research Network
Principal Investigator: Eric Claus, Ph.D. The Mind Research Network
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Responsible Party: The Mind Research Network
ClinicalTrials.gov Identifier: NCT04396847    
Other Study ID Numbers: 04719
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders