Addressing Post Cessation Weight Gain
Varenicline and Lorcaserin for Smoking Cessation and Weight Gain Prevention
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Subjects will be considered for inclusion if they meet all of the following
- ≥18 years and ≤65 years of age;
- smoked ≥10 cigarettes/day for the past 6 months;
- Body Mass Index of 27-39.9 kg/m2;
- motivated to stop smoking;
- weight concerned as shown with the Weight Concern Scale;
- able to participate fully in all aspects of the study;
- understand and signed the study informed consent.
- 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:
- 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.");
- current moderate or severe depression as assessed by a score of ≥16 on the Center for Epidemiology Studies-Depression;
- a lifetime history of psychosis, bipolar disorder or schizophrenia;
- use of anti-psychotic medication within the past 30 days;
- use of weight-loss medications within the past 30 days or current participation in a program specifically designed to help with weight loss;
- weight fluctuations of 20 pounds or more in the past 6 months (self-report);
- use of any treatments for tobacco dependence within the past 30 days;
- use of an investigational drug within the past 30 days;
- 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
- 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);
- uncontrolled hypertension (systolic >160 mm Hg and/or diastolic >100 mm Hg) documented on 2 separate occasions;
- current use of medications known to interact with varenicline or lorcaserin. These can include benzodiazepines, narcotics, anti-epileptics;
- another household member or relative participating in the study;
- known diabetes;
- a known allergy to varenicline or lorcaserin.
- 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.
- Has an unstable medical condition as determined by the physician investigator
- 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.
- Subject currently has cancer [excluding non-melanoma skin cancer] not in remission
- Known history of seizures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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:
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:
lorcaserin is an FDA-approved weight loss medication for overweight and obese patients
Other Names:
|
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Sponsor
Collaborators
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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