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

Study Timeline

• Study First Submitted: 2014-01-21
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-24
• Study Start: 2014-03
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Results First Submitted: 2016-04-14
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-27
• Last Update Submitted: 2019-03-27
• Results First Posted: 2019-04-16
• Last Update Posted: 2019-04-16

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

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

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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