A Study to Evaluate the Effect of Lorcaserin Hydrochloride on Smoking Cessation
- Conditions
- Smoking Cessation
- Interventions
- Drug: APD356-lorcaserin hydrochlorideDrug: 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
-
Males or females aged 18-65 years, inclusive
-
≥10 cigarettes per day with no period of abstinence longer than 3 months in the past year and who are motivated to quit smoking
-
Able to give signed informed consent
-
Eligible female patients will be:
- non-pregnant
- non-lactating
- agree to use an acceptable method of effective contraception during the study
-
Eligible male patients agree to use contraception when sexually active with a female partner who is not using an acceptable method of birth control
-
Body weight of ≥50 kg (110 pounds), inclusive
-
Considered to be in stable health in the opinion of the investigator
Patients who meet any of the following criteria will be excluded from the study.
- Prior or current use of lorcaserin HCl
- Prior participation in any study of a nicotine vaccination
- Use of other therapies for smoking cessation is not allowed within 3 months of screening through study exit
- Use of tobacco products other than cigarettes
- Prior use of fenfluramine or dexfenfluramine
- Serious or unstable medical condition or clinically significant new illness within the 6 months prior to screening
- Previous participation in any clinical study within 6 weeks prior to the screening visit
- History of severe allergies, severe drug or excipient allergy or hypersensitivity
- History of significant cardiovascular condition
- History of other significant medical conditions
- Significant risk of suicide
- Anticipated use of any agents that are associated with valvulopathy and/or pulmonary hypertension
- Positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Recent history of alcohol or drug/solvent abuse
- Concurrent participation in the study by more than one member of the same household
- Not suitable to participate in the study in the opinion of the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description APD356 10 mg b.i.d. APD356-lorcaserin hydrochloride APD356 - lorcaserin hydrochloride 10 mg tablet administered twice daily for 12 weeks Placebo 10 mg b.i.d Placebo Placebo tablet matching the APD356-lorcaserin hydrochloride 10 mg tablet administered twice daily for 12 weeks APD356 10 mg q.d. APD356-lorcaserin hydrochloride APD356 - lorcaserin hydrochloride 10 mg tablet administered once daily and one matching placebo tablet administered once daily for 12 weeks
- Primary Outcome Measures
Name Time Method Percentage of Participants With Abstinence for the Last 4 Weeks of Treatment From Weeks 9-12 Week 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
Name Time Method Abstinence During Weeks 3-12 Week 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 8 Week 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 12 Week 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 Weight Baseline to Week 12 Change in body weight from Week 1 (baseline) to Week 12
Related Research Topics
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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
Scroll for more (13 remaining)Pharmacology Research Institute🇺🇸Newport Beach, California, United States