Lorcaserin for Preventing Weight Gain Among Smokers

Lorcaserin for Preventing Weight Gain Among Smokers Receiving Varenicline: A Pilot Study

This will be an open label clinical trial with all subjects receiving both lorcaserin and varenicline with a primary aim of reducing post cessation weight gain.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder; Weight Gain
• Intervention / Treatment: Drug: Varenicline; Drug: Lorcaserin

Detailed Description

This will be an open label clinical trial with all subjects receiving both lorcaserin and varenicline. The investigators will obtain preliminary data on the efficacy of lorcaserin (10 mg twice daily) for 12 weeks in 20 adult weight-concerned cigarette smokers with a BMI of 27 to 40 simultaneously receiving 12 weeks of open-label varenicline and a behavioral intervention to assist with stopping smoking. Secondary aims will be weight, waist circumference, and smoking cessation.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

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:

1. ≥18 years and ≤65 years of age;
2. smoked ≥10 cigarettes/day for the past 6 months;
3. BMI of 27-40 kg/m2;
4. resides within the Olmsted County area;
5. motivated to stop smoking;
6. weight concerned as shown with the Weight Concern Scale;
7. able to participate fully in all aspects of the study;
8. understood and signed the study informed consent.

Exclusion Criteria:

1. current nonspecific suicidal thoughts or a lifetime history of a suicidal attempt (defined by the Columbia-Suicide Severity Rating Scale [C-SSRS] 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 Epidemiologic Studies-Depression (CES-D);
3. a lifetime history of 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;
10. current use of benzodiazepines, narcotics, anti-epileptics, or other medications known to interact with lorcaserin (see human subjects section);
11. current use of triptans, monoamine oxidase inhibitors, selective serotonin reuptake inhibitors (SSRIs), selective serotonin-norepinephrine reuptake inhibitors (SNRIs), dextromethorphan, tricyclic antidepressants (TCAs), bupropion, lithium, tramadol, tryptophan, and St. John's Wort, or any other medication known to involve the serotonergic neurotransmitter system (see human subjects section);
12. uncontrolled hypertension (systolic >160 mm Hg and/or diastolic >100 mm Hg) documented on 2 separate occasions;
13. clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, respiratory, or metabolic disease;
14. current use of medications known to interact with varenicline or lorcaserin;
15. another household member or relative participating in the study;
16. Known Diabetes;
17. a known allergy to varenicline or lorcaserin;
18. have taken antibiotics within the past 3 months.
19. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Varenicline + Lorcaserin; Open label all subjects receive both Varenicline and Lorcaserin	Drug: Varenicline; All subjects receive Varenicline; Other Names: Chantix; Drug: Lorcaserin; All subjects receive Lorcaserin; Other Names: Belviq

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Cessation Weight Change	change in weight from baseline to week 12	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist Circumference	Change in waist circumference from baseline to week 12	12 Weeks
Smoking Abstinence Rates	prolonged smoking abstinence at week 12	12 weeks
BMI	Change in BMI from baseline to week 12	12 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Ryan Hurt, MD, PhD, Mayo Clinic

Publications and helpful links

General Publications

• Hurt RT, Croghan IT, Schroeder DR, Hays JT, Choi DS, Ebbert JO. Combination Varenicline and Lorcaserin for Tobacco Dependence Treatment and Weight Gain Prevention in Overweight and Obese Smokers: A Pilot Study. Nicotine Tob Res. 2017 Aug 1;19(8):994-998. doi: 10.1093/ntr/ntw304.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 13, 2015
• First Submitted That Met QC Criteria: March 18, 2015
• First Posted (Estimate): March 19, 2015

Study Record Updates

• Last Update Posted (Actual): June 6, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: obesity
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Body Weight Changes; Tobacco Use Disorder; Body Weight; Weight Gain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: 13-007240