Lorcaserin for Preventing Weight Gain Among Smokers

Tobacco Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02393547
• Other study ID #: 13-007240
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 13, 2015
• Last updated: January 5, 2016
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Use Disorder
• Weight Gain

Intervention

Drug:
• Varenicline
All subjects receive Varenicline
• Lorcaserin
All subjects receive Lorcaserin

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post cessation weight gain		12 weeks	No
Secondary	Waist Circumference		12 Weeks	No
Secondary	Smoking abstinence rates		12 weeks	No
Secondary	BMI		12 weeks	No