Addressing Post Cessation Weight Gain

May 17, 2021 updated by: Ryan T. Hurt, M.D., Ph.D., Mayo Clinic

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects will be considered for inclusion if they meet all of the following

  1. ≥18 years and ≤65 years of age;
  2. smoked ≥10 cigarettes/day for the past 6 months;
  3. Body Mass Index of 27-39.9 kg/m2;
  4. motivated to stop smoking;
  5. weight concerned as shown with the Weight Concern Scale;
  6. able to participate fully in all aspects of the study;
  7. understand and signed the study informed consent.
  8. Subject is in good health as determined by the clinical investigators.

Exclusion Criteria:

Subjects will be ineligible for participation if they have any of the following:

  1. 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.");
  2. current moderate or severe depression as assessed by a score of ≥16 on the Center for Epidemiology Studies-Depression;
  3. a lifetime history of psychosis, bipolar disorder or schizophrenia;
  4. use of anti-psychotic medication within the past 30 days;
  5. use of weight-loss medications within the past 30 days or current participation in a program specifically designed to help with weight loss;
  6. weight fluctuations of 20 pounds or more in the past 6 months (self-report);
  7. use of any treatments for tobacco dependence within the past 30 days;
  8. use of an investigational drug within the past 30 days;
  9. 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
  10. 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);
  11. uncontrolled hypertension (systolic >160 mm Hg and/or diastolic >100 mm Hg) documented on 2 separate occasions;
  12. current use of medications known to interact with varenicline or lorcaserin. These can include benzodiazepines, narcotics, anti-epileptics;
  13. another household member or relative participating in the study;
  14. known diabetes;
  15. a known allergy to varenicline or lorcaserin.
  16. 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.
  17. Has an unstable medical condition as determined by the physician investigator
  18. 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.
  19. Subject currently has cancer [excluding non-melanoma skin cancer] not in remission
  20. Known history of seizures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Varenicline plus placebo
Subjects will receive open label varenicline (12 weeks) plus a placebo for lorcaserin (24 weeks)
Chantix is an FDA approved medication for smoking cessation
Other Names:
  • Chantix
Placebo for lorcaserin
Experimental: Varenicline plus lorcaserin
Subjects will receive open label varenicline (12 weeks) plus lorcaserin (24 weeks)
Chantix is an FDA approved medication for smoking cessation
Other Names:
  • Chantix
lorcaserin is an FDA-approved weight loss medication for overweight and obese patients
Other Names:
  • Belviq

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Cessation Weight Gain (kg)
Time Frame: 24 weeks
weight (kg) change from baseline to week 24 among subjects who meet criteria for prolonged smoking abstinence at week 24
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: 24 weeks
BMI change from baseline to week 24
24 weeks
Smoking Abstinence
Time Frame: 24 weeks
Lorcaserin combined with open label varenicline will be evaluated for improved smoking abstinence compared to placebo
24 weeks
Waist Circumference
Time Frame: 24 weeks
Waist Circumference change from baseline to week 24
24 weeks
Fat Mass
Time Frame: 24 weeks
Body Fat difference from baseline to week 24.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2016

Primary Completion (Actual)

April 17, 2020

Study Completion (Actual)

April 17, 2020

Study Registration Dates

First Submitted

March 12, 2015

First Submitted That Met QC Criteria

April 6, 2015

First Posted (Estimate)

April 9, 2015

Study Record Updates

Last Update Posted (Actual)

June 10, 2021

Last Update Submitted That Met QC Criteria

May 17, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 15-005230
  • 1K23DA037299-01A1 (U.S. NIH Grant/Contract)
  • 14-005682 (Other Identifier: Mayo Clinic)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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