Mechanisms of Lorcaserin for Smoking Cessation

NCT04396834 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 04619
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorder; Smoking Cessation

Outcome Measures

Primary Outcomes (2)

• Smoking Lapse

  Duration (in minutes) until lapsing to smoking during a 50-minute period

  Laboratory session following 7 days of medication or placebo pills

• Laboratory Cigarette Smoking

  Number of cigarettes consumed during a 60-minute period

  Laboratory session following 7 days of medication or placebo pills

Secondary Outcomes (3)

• Impulsivity

  Laboratory session following 7 days of medication or placebo pills.

• Reward Sensitivity

  Laboratory session following 7 days of medication or placebo pills.

• Daily Cigarette Smoking

  During 7 days of medication or during 7 days of placebo pills (difference score between weeks).

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

EXPERIMENTAL

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

You may qualify if:

• age 18-65
• smoking 5+ cigarettes per day (average) over the past year, with no period of abstinence \> 90 days
• biochemical verification of smoking status
• at least low to moderate nicotine dependence
• reporting long-term motivation to quit smoking
• willingness to take study pills and complete study procedures
• willingness to complete lab sessions involving cigarette smoking

You may not qualify if:

• meeting DSM-5 criteria for substance use disorder aside from tobacco use disorder and mild cannabis use disorder
• recent (30 day) illicit drug use (except marijuana), based on self-report and urine drug screen
• past 30-day use of tobacco cessation aids or nicotine/tobacco products other than cigarettes
• 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, including severe hepatic impairment or cirrhosis, or insulin dependent diabetes
• actively engaged in smoking cessation treatments or a smoking cessation attempt (or intent to start an attempt in the next 90 days)
• interested in quitting smoking immediately (i.e., in the next two months)
• Medications contraindicated for use with lorcaserin or which have a significant interaction with lorcaserin
• body mass index (BMI) under normal range (BMI \< 18 kg/m2)
• history of significant cardiovascular conditions including history of arrhythmias or heart block, heart failure, valvular heart disease, heart attack, stroke, unstable angina
• abnormal electrocardiogram (ECG) results
• nursing, pregnant, or anticipating pregnancy
• history of suicide attempt or recent 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

Tobacco Use Disorder; Smoking Cessation

Interventions

lorcaserin

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

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: December 4, 2019
• Primary Completion: February 26, 2020
• Study Completion: February 26, 2020
• Last Updated: March 20, 2023
• Results First Posted: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)