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Mechanisms of Lorcaserin for Smoking Cessation

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: NCT04396834
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:
Identifying new medication options is critical for curbing the health burdens of cigarette smoking. Currently approved smoking cessation medications act on nicotinic receptors, and additional work is needed to identify medications with alternate pharmacological targets. Based on evidence that the serotonin system plays a role in nicotine consumption and relapse, this study will examine whether a selective serotonin medication alters smoking-related behaviors and responses to cigarette smoking under controlled conditions, informing its potential utility for smoking cessation.

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

Detailed Description:

Tobacco use remains the foremost cause of preventable deaths in the U.S. and worldwide. Advancing new smoking cessation therapies, including those with novel pharmacological targets, is a critical public health priority. The serotonin (5-hydroxtytryptamine; 5-HT) system is broadly implicated in the regulation of reward- related behavior, including drug seeking, in part reflecting its modulatory role in dopamine (DA) function. Recent studies show that targeted manipulation of the serotonin 5-HT2C receptor alters drug-related behavior; in particular, 5-HT2C receptor agonists are shown to reduce nicotine intake and reinstatement. Of the selective 5-HT2C receptor agonists, lorcaserin has the best near-term potential for repurposing as a smoking cessation therapy, having been approved by the U.S. Food and Drug Administration for weight management.

Preclinical findings implicate several potential behavioral mechanisms by which 5-HT2C receptor agonists might reduce drug intake, including drug-specific processes (e.g., incentive salience of drug cues, self-administration, reinstatement) and drug-nonspecific behaviors (e.g., reductions in impulsivity). To date, potential mechanisms of 5-HT2C receptor agonists have not been characterized in human studies. Given emerging interest in lorcaserin as a novel smoking cessation therapy, further studies are needed to evaluate its efficacy profile, including studies to evaluate candidate treatment mechanisms. This human laboratory investigation will examine the effects of lorcaserin vs. placebo on relapse-related outcomes using a double-blind, within-subjects, crossover design. Impulsivity subdomains will also be examined as candidate mechanisms for medication effects. By evaluating an approved 5-HT2C agonist with emergent efficacy for smoking cessation, this project has near-term potential to inform clinical applications of 5-HT2C agonists for addiction.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Behavioral Mechanisms of Lorcaserin Treatment for Smoking Cessation
Actual Study Start Date : December 4, 2019
Actual Primary Completion Date : February 26, 2020
Actual Study Completion Date : February 26, 2020

Resource links provided by the National Library of Medicine

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. Smoking lapse [ Time Frame: Laboratory session following 7 days of medication vs. laboratory session following 7 days of placebo pills (difference score between sessions). ]
    Duration (in minutes) until lapsing to smoking during a 50-minute period

  2. Laboratory cigarette smoking [ Time Frame: Laboratory session following 7 days of medication vs. laboratory session following 7 days of placebo pills (difference score between sessions). ]
    Number of cigarettes consumed during a 60-minute period


Secondary Outcome Measures :
  1. Impulsivity [ Time Frame: Laboratory session following 7 days of medication vs. laboratory session following 7 days of placebo pills (difference score between sessions). ]
    Performance on a behavioral measure of impulsivity

  2. Cigarette craving [ 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 craving when presented with a cigarette, as measured by the Tiffany Questionnaire of Smoking Urges

  3. Subjective cigarette effects [ Time Frame: Laboratory session following 7 days of medication vs. laboratory session following 7 days of placebo pills (difference score between sessions). ]
    Subjective responses to laboratory cigarette smoking, as measured by the Drug Effects Questionnaire.

  4. Reward sensitivity [ Time Frame: Laboratory session following 7 days of medication vs. laboratory session following 7 days of placebo pills (difference score between sessions). ]
    Performance on a behavioral measure of reward sensitivity (signal detection task)

  5. Daily cigarette smoking [ Time Frame: During 7 days of medication vs. during 7 days of placebo pills (difference score between weeks). ]
    Cigarettes smoked per day



Information from the National Library of Medicine

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Ages Eligible for Study:   18 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 18-65
  2. smoking 5+ cigarettes per day (average) over the past year, with no period of abstinence > 90 days
  3. biochemical verification of smoking status
  4. at least low to moderate nicotine dependence
  5. reporting long-term motivation to quit smoking
  6. willingness to take study pills and complete study procedures
  7. willingness to complete lab sessions involving cigarette smoking

Exclusion Criteria:

  1. meeting DSM-5 criteria for substance use disorder aside from tobacco use disorder and mild cannabis use disorder
  2. recent (30 day) illicit drug use (except marijuana), based on self-report and urine drug screen
  3. past 30-day use of tobacco cessation aids or nicotine/tobacco products other than cigarettes
  4. past 30-day use of SSRIs, other psychiatric medications, or weight control medications
  5. lifetime diagnosis of severe mental illness (e.g., psychotic or bipolar I disorder)
  6. significant medical or neurological illness, including severe hepatic impairment or cirrhosis, or insulin dependent diabetes
  7. actively engaged in smoking cessation treatments or a smoking cessation attempt (or intent to start an attempt in the next 90 days)
  8. interested in quitting smoking immediately (i.e., in the next two months)
  9. Medications contraindicated for use with lorcaserin or which have a significant interaction with lorcaserin
  10. body mass index (BMI) under normal range (BMI < 18 kg/m2)
  11. history of significant cardiovascular conditions including history of arrhythmias or heart block, heart failure, valvular heart disease, heart attack, stroke, unstable angina
  12. abnormal electrocardiogram (ECG) results
  13. nursing, pregnant, or anticipating pregnancy
  14. history of suicide attempt or recent 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): NCT04396834


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: NCT04396834    
Other Study ID Numbers: 04619
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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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders