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Smoking CessationPhase 2NCT02044874

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

A Phase 2 study testing APD356-lorcaserin hydrochloride in people with Smoking Cessation, run by Arena Pharmaceuticals at 31 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Smoking Cessation
What is being tested?
APD356-lorcaserin hydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
603 participants
Where
31 sitesUnited States
Study dates
Mar 2014to Nov 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

United States31 sites

  • Benchmark Research

    Austin, Texas, 78705

  • Integrative Clinical Trials

    Brooklyn, New York, 11229

  • Neurobehavioral Clinical Research

    Canton, Ohio, 44718

  • KRK Medical Research

    Dallas, Texas, 75230

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417

  • iResearch Atlanta

    Decatur, Georgia, 30030

  • Avail Clinical Research

    DeLand, Florida, 32720

  • Duke University

    Durham, North Carolina, 27705

  • Pharmacology Research Institute

    Encino, California, 91316

  • Synergy Escondido

    Escondido, California, 92025

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32256

  • Clinical Trial Center

    Jenkintown, Pennsylvania, 19046

  • Center for Pharmaceutical Research

    Kansas City, Missouri, 64114

  • Meridien Research

    Lakeland, Florida, 33805

  • Clinical Research Center of Nevada

    Las Vegas, Nevada, 89104

  • Compass Research East

    Leesburg, Florida, 34748

  • Lincoln Research

    Lincoln, Rhode Island, 02865

  • Pharmacology Research Institute

    Los Alamitos, California, 90720

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee, 38119

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Clinical Research Associates, Inc.

    Nashville, Tennessee, 37203

  • Pharmacology Research Institute

    Newport Beach, California, 92660

  • Quality Clinical Research Inc.

    Omaha, Nebraska, 68114

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32806

  • Compass Research

    Orlando, Florida, 32806

  • Compass Research East

    Oviedo, Florida, 32765

  • PMG Research Inc.

    Raleigh, North Carolina, 27609

  • Desert Valley Research

    Rancho Mirage, California, 92270

  • Meridien Research

    Tampa, Florida, 33606

  • PMG Research Inc.

    Wilmington, North Carolina, 28401

  • PMG Research Inc.

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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

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.

Being tested
APD356-lorcaserin hydrochloride, Placebo
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • APD356-lorcaserin hydrochlorideDrug

    Also called Belviq

  • PlaceboDrug

Study groups in NCT02044874
Study groupRoleWhat they receive
APD356 10 mg b.i.d.ExperimentalAPD356 - lorcaserin hydrochloride 10 mg tablet administered twice daily for 12 weeks
Receives: Drug: APD356-lorcaserin hydrochloride
APD356 10 mg q.d.ExperimentalAPD356 - lorcaserin hydrochloride 10 mg tablet administered once daily and one matching placebo tablet administered once daily for 12 weeks
Receives: Drug: APD356-lorcaserin hydrochloride
Placebo 10 mg b.i.dPlacebo comparatorPlacebo tablet matching the APD356-lorcaserin hydrochloride 10 mg tablet administered twice daily for 12 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 9 - Week 12

Secondary outcomes (4)

  1. 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

    Measured: Week 3 to Week 12

  2. 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

    Measured: Week 8

  3. 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

    Measured: Week 12

  4. Body Weight

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

    Measured: Baseline to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
603 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02044874
Sponsor's protocol ID
APD356-035
Status last verified
Mar 2019
First submitted
21 Jan 2014
Last updated
16 Apr 2019
Data monitoring committee
No

Publications

  • Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.

    PubMed 34611902

  • Shanahan WR, Rose JE, Glicklich A, Stubbe S, Sanchez-Kam M. Lorcaserin for Smoking Cessation and Associated Weight Gain: A Randomized 12-Week Clinical Trial. Nicotine Tob Res. 2017 Aug 1;19(8):944-951. doi: 10.1093/ntr/ntw301.

    PubMed 27815511

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing APD356-lorcaserin hydrochloride in people with Smoking Cessation, run by Arena Pharmaceuticals at 31 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Abstinence for the Last 4 Weeks of Treatment From Weeks 9-12 (time frame: Week 9 - Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02044874, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.

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