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A Study to Evaluate the Effect of Lorcaserin Hydrochloride on Smoking Cessation

Phase 2
Completed
Conditions
Smoking Cessation
Interventions
Drug: APD356-lorcaserin hydrochloride
Drug: Placebo
Registration Number
NCT02044874
Lead Sponsor
Arena Pharmaceuticals
Brief Summary

In smokers who are motivated to stop smoking, treatment with lorcaserin compared with placebo will provide greater abstinence as measured by the last 4 weeks of treatment (Weeks 9-12). The target quit date was Day 15.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
603
Inclusion Criteria
  1. Males or females aged 18-65 years, inclusive

  2. ≥10 cigarettes per day with no period of abstinence longer than 3 months in the past year and who are motivated to quit smoking

  3. Able to give signed informed consent

  4. Eligible female patients will be:

    1. non-pregnant
    2. non-lactating
    3. agree to use an acceptable method of effective contraception during the study
  5. Eligible male patients agree to use contraception when sexually active with a female partner who is not using an acceptable method of birth control

  6. Body weight of ≥50 kg (110 pounds), inclusive

  7. Considered to be in stable health in the opinion of the investigator

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from the study.

  1. Prior or current use of lorcaserin HCl
  2. Prior participation in any study of a nicotine vaccination
  3. Use of other therapies for smoking cessation is not allowed within 3 months of screening through study exit
  4. Use of tobacco products other than cigarettes
  5. Prior use of fenfluramine or dexfenfluramine
  6. Serious or unstable medical condition or clinically significant new illness within the 6 months prior to screening
  7. Previous participation in any clinical study within 6 weeks prior to the screening visit
  8. History of severe allergies, severe drug or excipient allergy or hypersensitivity
  9. History of significant cardiovascular condition
  10. History of other significant medical conditions
  11. Significant risk of suicide
  12. Anticipated use of any agents that are associated with valvulopathy and/or pulmonary hypertension
  13. Positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  14. Recent history of alcohol or drug/solvent abuse
  15. Concurrent participation in the study by more than one member of the same household
  16. Not suitable to participate in the study in the opinion of the investigator

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
APD356 10 mg b.i.d.APD356-lorcaserin hydrochlorideAPD356 - lorcaserin hydrochloride 10 mg tablet administered twice daily for 12 weeks
Placebo 10 mg b.i.dPlaceboPlacebo tablet matching the APD356-lorcaserin hydrochloride 10 mg tablet administered twice daily for 12 weeks
APD356 10 mg q.d.APD356-lorcaserin hydrochlorideAPD356 - lorcaserin hydrochloride 10 mg tablet administered once daily and one matching placebo tablet administered once daily for 12 weeks
Primary Outcome Measures
NameTimeMethod
Percentage of Participants With Abstinence for the Last 4 Weeks of Treatment From Weeks 9-12Week 9 - Week 12

Primary efficacy was assessed as the CO (carbon monoxide)-confirmed continuous abstinence rate for the last 4 weeks of treatment (Month 3: Weeks 9 through 12), defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels \<= 10 ppm.

Secondary Outcome Measures
NameTimeMethod
Abstinence During Weeks 3-12Week 3 to Week 12

The CO (carbon monoxide)-confirmed continuous abstinence rate for Weeks 3 through 12, defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels \<= 10 ppm

The 7 Day Point Prevalence or Weekly Abstinence at Week 8Week 8

The CO (carbon monoxide)-confirmed continuous abstinence rate at for the 7-day period preceding the Week 8 visit, defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels \<= 10 ppm

The 7 Day Point Prevalence or Weekly Abstinence at Week 12Week 12

The CO (carbon monoxide)-confirmed continuous abstinence rate at for the 7-day period preceding the Week 12 visit, defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels \<= 10 ppm

Body WeightBaseline to Week 12

Change in body weight from Week 1 (baseline) to Week 12

Trial Locations

Locations (23)

Pharmacology Research Institute

🇺🇸

Newport Beach, California, United States

Synergy Escondido

🇺🇸

Escondido, California, United States

Desert Valley Research

🇺🇸

Rancho Mirage, California, United States

Avail Clinical Research

🇺🇸

DeLand, Florida, United States

Clinical Neuroscience Solutions, Inc.

🇺🇸

Memphis, Tennessee, United States

Meridien Research

🇺🇸

Tampa, Florida, United States

Compass Research East

🇺🇸

Oviedo, Florida, United States

Compass Research

🇺🇸

Orlando, Florida, United States

iResearch Atlanta

🇺🇸

Decatur, Georgia, United States

Center for Pharmaceutical Research

🇺🇸

Kansas City, Missouri, United States

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Pharmacology Research Institute
🇺🇸Newport Beach, California, United States

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