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

Smoking Cessation Clinical Trial

Official title:

A 12-Week, Multicenter, Double-blind, Randomized, Placebo-controlled Parallel-group Phase 2 Dose Selection Study of Lorcaserin Hydrochloride, an Oral 5-HT2C Receptor Agonist for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02044874
• Other study ID #: APD356-035
• Status: Completed
• Phase: Phase 2
• Start date: March 2014
• Est. completion date: November 2014

Study information

• Verified date: March 2019
• Source: Arena Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 603
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• APD356-lorcaserin hydrochloride

• Placebo

Locations

Country	Name	City	State
United States	Benchmark Research	Austin	Texas
United States	Integrative Clinical Trials	Brooklyn	New York
United States	Neurobehavioral Clinical Research	Canton	Ohio
United States	KRK Medical Research	Dallas	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	iResearch Atlanta	Decatur	Georgia
United States	Avail Clinical Research	DeLand	Florida
United States	Duke University	Durham	North Carolina
United States	Pharmacology Research Institute	Encino	California
United States	Synergy Escondido	Escondido	California
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Clinical Trial Center	Jenkintown	Pennsylvania
United States	Center for Pharmaceutical Research	Kansas City	Missouri
United States	Meridien Research	Lakeland	Florida
United States	Clinical Research Center of Nevada	Las Vegas	Nevada
United States	Compass Research East	Leesburg	Florida
United States	Lincoln Research	Lincoln	Rhode Island
United States	Pharmacology Research Institute	Los Alamitos	California
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Clinical Research Associates, Inc.	Nashville	Tennessee
United States	Pharmacology Research Institute	Newport Beach	California
United States	Quality Clinical Research Inc.	Omaha	Nebraska
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Compass Research	Orlando	Florida
United States	Compass Research East	Oviedo	Florida
United States	PMG Research Inc.	Raleigh	North Carolina
United States	Desert Valley Research	Rancho Mirage	California
United States	Meridien Research	Tampa	Florida
United States	PMG Research Inc.	Wilmington	North Carolina
United States	PMG Research Inc.	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Arena Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Abstinence for the Last 4 Weeks of Treatment From Weeks 9-12	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.	Week 9 - Week 12
Secondary	Abstinence During Weeks 3-12	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	Week 3 to Week 12
Secondary	The 7 Day Point Prevalence or Weekly Abstinence at 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	Week 8
Secondary	The 7 Day Point Prevalence or Weekly Abstinence at 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	Week 12
Secondary	Body Weight	Change in body weight from Week 1 (baseline) to Week 12	Baseline to Week 12