Lorcaserin for Preventing Weight Gain Among Smokers

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT02393547
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 27
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Use Disorder; Weight Gain	Drug: Varenicline; Drug: Lorcaserin	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Lorcaserin for Preventing Weight Gain Among Smokers Receiving Varenicline: A Pilot Study
• Actual Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Post Cessation Weight Change [12 weeks]

   change in weight from baseline to week 12

Secondary Outcome Measures

1. Waist Circumference [12 Weeks]

   Change in waist circumference from baseline to week 12

2. Smoking Abstinence Rates [12 weeks]

   prolonged smoking abstinence at week 12

3. BMI [12 weeks]

   Change in BMI from baseline to week 12

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ryan T. Hurt, M.D., Ph.D., Associate Professor, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02393547
• Other Study ID Numbers: 13-007240
• First Posted: Mar 19, 2015
• Last Update Posted: Jun 6, 2017
• Last Verified: May 1, 2017

• Keywords provided by Ryan T. Hurt, M.D., Ph.D., Associate Professor, Mayo Clinic: obesity
• Additional relevant MeSH terms: Body Weight; Weight Gain; Tobacco Use Disorder; Varenicline

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from the community surrounding Mayo Clinic (Rochester, MN) between September 2013 and July 2014. Overweight or obese daily smokers who were interested in stopping cigarette use were recruited through the news media and local advertisements in Rochester, MN.
Pre-assignment Detail	The current study included an initial telephone screen.After the initial screen, eligible subjects were invited to come for potential enrollment. Visits prior accrual (drug dispensing) included an information meeting (screening, physician physical exam, and informed consent) and baseline visit (screening, baseline measures and drug dispensing).

Arm/Group Title	Varenicline + Lorcaserin
Arm/Group Description	Open label all subjects receive both Varenicline and Lorcaserin Varenicline: All subjects receive Varenicline Lorcaserin: All subjects receive Lorcaserin
Period Title: Overall Study
STARTED	20
COMPLETED	14
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Varenicline + Lorcaserin
Arm/Group Description	Open label all subjects receive both Varenicline and Lorcaserin Varenicline: All subjects receive Varenicline Lorcaserin: All subjects receive Lorcaserin
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	20 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.7 (11.4)
Sex: Female, Male (Count of Participants)
Female	12 60%
Male	8 40%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 5%
Not Hispanic or Latino	19 95%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	20 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	90.3 (26.2)
Body Mass Index (units on a scale -- kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale -- kg/m^2]	30.4 (4.5)
Waist Circumference (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	102.1 (16.0)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

subjects (n=10) who met criteria for prolonged smoking abstinence at week 12

Arm/Group Title	Varenicline + Lorcaserin
Arm/Group Description	Open label all subjects receive both Varenicline and Lorcaserin Varenicline: All subjects receive Varenicline Lorcaserin: All subjects receive Lorcaserin
Measure Participants	10
Mean (Standard Deviation) [kg]	1.1 (3.9)

2. Secondary Outcome

Title	Waist Circumference
Description	Change in waist circumference from baseline to week 12
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

subjects (n=10) who met criteria for prolonged smoking abstinence at week 12

Arm/Group Title	Varenicline + Lorcaserin
Arm/Group Description	Open label all subjects receive both Varenicline and Lorcaserin Varenicline: All subjects receive Varenicline Lorcaserin: All subjects receive Lorcaserin
Measure Participants	10
Mean (Standard Deviation) [cm]	0.2 (6.0)

3. Secondary Outcome

Title	Smoking Abstinence Rates
Description	prolonged smoking abstinence at week 12
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Varenicline + Lorcaserin
Arm/Group Description	Open label all subjects receive both Varenicline and Lorcaserin Varenicline: All subjects receive Varenicline Lorcaserin: All subjects receive Lorcaserin
Measure Participants	20
Count of Participants [Participants]	10 50%

4. Secondary Outcome

Title	BMI
Description	Change in BMI from baseline to week 12
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

subjects (N=10) who met criteria for prolonged smoking abstinence at week 12

Arm/Group Title	Varenicline + Lorcaserin
Arm/Group Description	Open label all subjects receive both Varenicline and Lorcaserin Varenicline: All subjects receive Varenicline Lorcaserin: All subjects receive Lorcaserin
Measure Participants	10
Mean (Standard Deviation) [kg/m^2]	0.3 (1.3)

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Varenicline + Lorcaserin
Arm/Group Description	Open label all subjects receive both Varenicline and Lorcaserin Varenicline: All subjects receive Varenicline Lorcaserin: All subjects receive Lorcaserin
All Cause Mortality
	Varenicline + Lorcaserin
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	Varenicline + Lorcaserin
	Affected / at Risk (%)	# Events
Total	1/20 (5%)
Psychiatric disorders
Suicidal Ideation	1/20 (5%)	1
Other (Not Including Serious) Adverse Events
	Varenicline + Lorcaserin
	Affected / at Risk (%)	# Events
Total	7/20 (35%)
Gastrointestinal disorders
constipation	2/20 (10%)	3
heart burn	1/20 (5%)	1
General disorders
sleep disturbance	4/20 (20%)	5
nausea	3/20 (15%)	3
dry mouth	1/20 (5%)	1
Nervous system disorders
headaches	1/20 (5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.