Tobacco Use Disorder, Weight Gain
Conditions
Keywords
obesity
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.
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.
Interventions
DRUGVarenicline
All subjects receive Varenicline
DRUGLorcaserin
All subjects receive Lorcaserin
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Cessation Weight Change | 12 weeks | change in weight from baseline to week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Waist Circumference | 12 Weeks | Change in waist circumference from baseline to week 12 |
| Smoking Abstinence Rates | 12 weeks | prolonged smoking abstinence at week 12 |
| BMI | 12 weeks | Change in BMI from baseline to week 12 |
Countries
United States
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 details
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).
Participants by arm
| Arm | Count |
|---|---|
| Varenicline + Lorcaserin Open label all subjects receive both Varenicline and Lorcaserin
Varenicline: All subjects receive Varenicline
Lorcaserin: All subjects receive Lorcaserin | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Varenicline + Lorcaserin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 41.7 years STANDARD_DEVIATION 11.4 |
| Body Mass Index | 30.4 units on a scale -- kg/m^2 STANDARD_DEVIATION 4.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 8 Participants |
| Waist Circumference | 102.1 cm STANDARD_DEVIATION 16 |
| Weight | 90.3 kg STANDARD_DEVIATION 26.2 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 7 / 20 |
| serious Total, serious adverse events | 1 / 20 |
Outcome results
Primary
Post Cessation Weight Change
change in weight from baseline to week 12
Time frame: 12 weeks
Population: subjects (n=10) who met criteria for prolonged smoking abstinence at week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Varenicline + Lorcaserin | Post Cessation Weight Change | 1.1 kg | Standard Deviation 3.9 |
Secondary
BMI
Change in BMI from baseline to week 12
Time frame: 12 weeks
Population: subjects (N=10) who met criteria for prolonged smoking abstinence at week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Varenicline + Lorcaserin | BMI | 0.3 kg/m^2 | Standard Deviation 1.3 |
Secondary
Smoking Abstinence Rates
prolonged smoking abstinence at week 12
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Varenicline + Lorcaserin | Smoking Abstinence Rates | 10 Participants |
Secondary
Waist Circumference
Change in waist circumference from baseline to week 12
Time frame: 12 Weeks
Population: subjects (n=10) who met criteria for prolonged smoking abstinence at week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Varenicline + Lorcaserin | Waist Circumference | 0.2 cm | Standard Deviation 6 |