Clinical trial NCT02044874: A Study to Evaluate the Effect of Lorcaserin Hydrochloride on Smoking Cessation
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Cessation
Lead sponsor: Arena Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-01-24
Enrollment: 603
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Abstinence for the Last 4 Weeks of Treatment From Weeks 9-12
timeFrame: Week 9 - Week 12
Secondary outcomes:
measure: Abstinence During Weeks 3-12
timeFrame: Week 3 to Week 12
measure: The 7 Day Point Prevalence or Weekly Abstinence at Week 8
timeFrame: Week 8
measure: The 7 Day Point Prevalence or Weekly Abstinence at Week 12
timeFrame: Week 12
measure: Body Weight
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Encino
country: United States
facility: Pharmacology Research Institute
state: California
city: Escondido
country: United States
facility: Synergy Escondido
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: Rancho Mirage
country: United States
facility: Desert Valley Research
state: California
city: DeLand
country: United States
facility: Avail Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Lakeland
country: United States
facility: Meridien Research
state: Florida
city: Leesburg
country: United States
facility: Compass Research East
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: Compass Research
state: Florida
city: Oviedo
country: United States
facility: Compass Research East
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Decatur
country: United States
facility: iResearch Atlanta
state: Georgia
city: Kansas City
country: United States
facility: Center for Pharmaceutical Research
state: Missouri
city: Omaha
country: United States
facility: Quality Clinical Research Inc.
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Brooklyn
country: United States
facility: Integrative Clinical Trials
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Raleigh
country: United States
facility: PMG Research Inc.
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research Inc.
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research Inc.
state: North Carolina
city: Canton
country: United States
facility: Neurobehavioral Clinical Research
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Jenkintown
country: United States
facility: Clinical Trial Center
state: Pennsylvania
city: Lincoln
country: United States
facility: Lincoln Research
state: Rhode Island
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Dallas
country: United States
facility: KRK Medical Research
state: Texas
Study officials:
affiliation: Desert Valley Research; Rancho Mirage, California
name: Donald Anderson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.