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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02044874
Recruitment Status : Completed
First Posted : January 24, 2014
Results First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: APD356-lorcaserin hydrochloride Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 603 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : March 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: APD356 10 mg b.i.d.
APD356 - lorcaserin hydrochloride 10 mg tablet administered twice daily for 12 weeks
Drug: APD356-lorcaserin hydrochloride
Other Name: Belviq

Experimental: APD356 10 mg q.d.
APD356 - lorcaserin hydrochloride 10 mg tablet administered once daily and one matching placebo tablet administered once daily for 12 weeks
Drug: APD356-lorcaserin hydrochloride
Other Name: Belviq

Placebo Comparator: Placebo 10 mg b.i.d
Placebo tablet matching the APD356-lorcaserin hydrochloride 10 mg tablet administered twice daily for 12 weeks
Drug: Placebo



Primary Outcome Measures :
  1. Percentage of Participants With Abstinence for the Last 4 Weeks of Treatment From Weeks 9-12 [ Time Frame: 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 :
  1. Abstinence During Weeks 3-12 [ Time Frame: 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

  2. The 7 Day Point Prevalence or Weekly Abstinence at Week 8 [ Time Frame: 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

  3. The 7 Day Point Prevalence or Weekly Abstinence at Week 12 [ Time Frame: 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

  4. Body Weight [ Time Frame: Baseline to Week 12 ]
    Change in body weight from Week 1 (baseline) to Week 12



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044874


Locations
Show Show 31 study locations
Sponsors and Collaborators
Arena Pharmaceuticals
Investigators
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Principal Investigator: Donald Anderson, M.D. Desert Valley Research; Rancho Mirage, California

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Arena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02044874    
Other Study ID Numbers: APD356-035
First Posted: January 24, 2014    Key Record Dates
Results First Posted: April 16, 2019
Last Update Posted: April 16, 2019
Last Verified: March 2019