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ObesityPhase 2/3NCT02412631

Addressing Post Cessation Weight Gain

A Phase 2/3 study testing lorcaserin and Varenicline in people with Obesity and Smoking Cessation, run by Mayo Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Some individuals smoke with the perception that smoking helps control body weight. Smokers gain an average of as much as 10 pounds in the months following smoking abstinence, with heavier and more-dependent smokers gaining more weight. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Smoking Cessation
What is being tested?
lorcaserin and Varenicline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
1 siteUnited States
Study dates
15 Jun 2016to 17 Apr 2020
Phase
Phase 2/3
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects will be considered for inclusion if they meet all of the following
  • ≥18 years and ≤65 years of age;
  • smoked ≥10 cigarettes/day for the past 6 months;
  • Body Mass Index of 27-39.9 kg/m2;
  • motivated to stop smoking;
  • weight concerned as shown with the Weight Concern Scale;
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  • able to participate fully in all aspects of the study;
  • understand and signed the study informed consent.
  • Subject is in good health as determined by the clinical investigators.

Who cannot join

  • Subjects will be ineligible for participation if they have any of the following:
  • current nonspecific suicidal thoughts or a lifetime history of a suicidal attempt (defined by the Columbia-Suicide Severity Rating Scale as a "potentially self-injurious act committed with at least some wish to die, as a result of act.");
  • current moderate or severe depression as assessed by a score of ≥16 on the Center for Epidemiology Studies-Depression;
  • a lifetime history of psychosis, bipolar disorder or schizophrenia;
  • use of anti-psychotic medication within the past 30 days;
  • use of weight-loss medications within the past 30 days or current participation in a program specifically designed to help with weight loss;
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  • weight fluctuations of 20 pounds or more in the past 6 months (self-report);
  • use of any treatments for tobacco dependence within the past 30 days;
  • use of an investigational drug within the past 30 days;
  • recent history (past 3 months) of abuse of or dependence on a substance other than tobacco. Including: heavy alcohol consumption (If male, drinking > 4 alcoholic beverages per day for past month and if female, drinking > 3 alcoholic beverages per day for past month); use of cocaine, heroin, club drugs (i.e., methylenedioxymethamphetamine(MDMA)/"ecstasy"), methamphetamine, or hallucinogens (e.g., LSD) at any time during the past 3 months; and use of marijuana on a weekly basis for the past 3 months
  • current use of triptans, monoamine oxidase inhibitors, selective serotonin reuptake inhibitors (SSRI), selective serotonin-norepinephrine re-uptake inhibitors (SNRI), dextromethorphan, tricyclic antidepressants (TCA), bupropion, lithium, tramadol, tryptophan, and St. John's Wort, or any other medication known to involve the serotonergic neurotransmitter system (see human subjects section);
  • uncontrolled hypertension (systolic >160 mm Hg and/or diastolic >100 mm Hg) documented on 2 separate occasions;
  • current use of medications known to interact with varenicline or lorcaserin. These can include benzodiazepines, narcotics, anti-epileptics;
  • another household member or relative participating in the study;
  • known diabetes;
  • a known allergy to varenicline or lorcaserin.
  • Women who are pregnant or lactating, or who are of childbearing potential and are likely to become pregnant during the medication phase but are not willing to use a reliable form of contraception, will also be excluded. Reliable forms of contraception include oral contraception, diaphragm or condom (with spermicide), injections, intrauterine device, surgical sterilization, and abstinence.
  • Has an unstable medical condition as determined by the physician investigator
  • Subject describes having a medical history of: a) unstable angina; b) myocardial infarction within the past 3 months; c) coronary angioplasty or d) an untreated cardiac dysrhythmia.
  • Subject currently has cancer [excluding non-melanoma skin cancer] not in remission
  • Known history of seizures

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Varenicline and Lorcaserin for Smoking Cessation and Weight Gain Prevention

Some individuals smoke with the perception that smoking helps control body weight. Smokers gain an average of as much as 10 pounds in the months following smoking abstinence, with heavier and more-dependent smokers gaining more weight. T The Mayo Clinic Nicotine Research Program will randomize 100 nondiabetic, overweight or obese adult smokers to active lorcaserin or placebo for 24 weeks; all of the subjects will receive open-label varenicline for 12 weeks. The purpose of this study is to assess the efficacy of a 24-week course of lorcaserin for decreasing weight gain after stopping smoking.

Read the detailed description

This will be a randomized, placebo-controlled, parallel-group clinical trial. Nondiabetic, overweight and obese adult smokers will be randomized to one of three arms:

  • lorcaserin for 24 weeks in combination with varenicline for 12 weeks;
  • placebo for 24 weeks in combination with varenicline for 12 weeks;

We will assess the following:

  • changes in weight and Weight Concern
  • 7-day point-prevalence smoking abstinence weekly through week 24 and prolonged smoking abstinence at 24 and 52 weeks. Subjects will have a target quit date 8 days after starting medication.
Being tested
lorcaserin, Varenicline, Placebo
Medical subject headings
Obesity, Smoking Cessation

What participants receive

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

  • lorcaserinDrug

    Also called Belviq

    lorcaserin is an FDA-approved weight loss medication for overweight and obese patients

  • VareniclineDrug

    Also called Chantix

    Chantix is an FDA approved medication for smoking cessation

  • PlaceboDrug

    Placebo for lorcaserin

Study groups in NCT02412631
Study groupRoleWhat they receive
Varenicline plus placeboPlacebo comparatorSubjects will receive open label varenicline (12 weeks) plus a placebo for lorcaserin (24 weeks)
Receives: Drug: Varenicline; Drug: Placebo
Varenicline plus lorcaserinExperimentalSubjects will receive open label varenicline (12 weeks) plus lorcaserin (24 weeks)
Receives: Drug: lorcaserin; Drug: Varenicline

What is being measured

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

  1. Post Cessation Weight Gain (kg)

    weight (kg) change from baseline to week 24 among subjects who meet criteria for prolonged smoking abstinence at week 24

    Measured: 24 weeks

Secondary outcomes (4)

  1. BMI

    BMI change from baseline to week 24

    Measured: 24 weeks

  2. Smoking Abstinence

    Lorcaserin combined with open label varenicline will be evaluated for improved smoking abstinence compared to placebo

    Measured: 24 weeks

  3. Waist Circumference

    Waist Circumference change from baseline to week 24

    Measured: 24 weeks

  4. Fat Mass

    Body Fat difference from baseline to week 24.

    Measured: 24 weeks

Timeline

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

  1. First posted9 Apr 2015 (estimated)
  2. Study start15 Jun 2016
  3. Primary completion17 Apr 2020
  4. Study completion17 Apr 2020

Why it stopped: Lorcaserin removed from market

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02412631
Sponsor's protocol ID
15-005230
Other IDs
1K23DA037299-01A1, 14-005682
Status last verified
May 2021
First submitted
12 Mar 2015
Last updated
10 Jun 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hurt RT, Croghan IT, Schroeder DR, Choi DS, Fischer K, Fokken S, Ebbert JO. Varenicline and Lorcaserin for Smoking Cessation and Weight Gain Prevention: A Randomized Clinical Trial. Mayo Clin Proc Innov Qual Outcomes. 2022 Sep 21;6(5):465-474. doi: 10.1016/j.mayocpiqo.2022.01.004. eCollection 2022 Oct.

    PubMed 36160639

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing lorcaserin and Varenicline in people with Obesity and Smoking Cessation, run by Mayo Clinic at 1 site 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 9 inclusion and 21 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: stopped early, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 10 Jun 2021). 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?

Post Cessation Weight Gain (kg) (time frame: 24 weeks). 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 NCT02412631, which also lists 1 linked publication.

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 10 Jun 2021; AzTrials last refreshed its copy on 27 Oct 2026.

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