Tobacco Use DisorderPhase 1/2NCT02393547
Lorcaserin for Preventing Weight Gain Among Smokers
A Phase 1/2 study testing Varenicline and Lorcaserin in people with Tobacco Use Disorder and Weight Gain, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder, Weight Gain
- What is being tested?
- Varenicline and Lorcaserin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Dec 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years and ≤65 years of age;
- smoked ≥10 cigarettes/day for the past 6 months;
- BMI of 27-40 kg/m2;
- resides within the Olmsted County area;
- motivated to stop smoking;
- weight concerned as shown with the Weight Concern Scale;
- able to participate fully in all aspects of the study;
- understood and signed the study informed consent.
Who cannot join
- 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.");
- current moderate or severe depression as assessed by a score of ≥16 on the Center for Epidemiologic Studies-Depression (CES-D);
- a lifetime history of 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);
Show all 19Show fewer
- 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;
- current use of benzodiazepines, narcotics, anti-epileptics, or other medications known to interact with lorcaserin (see human subjects section);
- 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);
- uncontrolled hypertension (systolic >160 mm Hg and/or diastolic >100 mm Hg) documented on 2 separate occasions;
- clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, respiratory, or metabolic disease;
- current use of medications known to interact with varenicline or lorcaserin;
- another household member or relative participating in the study;
- Known Diabetes;
- a known allergy to varenicline or lorcaserin;
- have taken antibiotics within the past 3 months.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
Read the 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.
- Conditions
- Tobacco Use Disorder, Weight Gain
- Being tested
- Varenicline, Lorcaserin
- Keywords
- obesity
- Medical subject headings
- Tobacco Use Disorder, Weight Gain, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Chantix
All subjects receive Varenicline
LorcaserinDrug
Also called Belviq
All subjects receive Lorcaserin
| Study group | Role | What they receive |
|---|---|---|
| Varenicline + Lorcaserin | Experimental | Open label all subjects receive both Varenicline and Lorcaserin Receives: Drug: Varenicline; Drug: Lorcaserin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Cessation Weight Change
change in weight from baseline to week 12
Measured: 12 weeks
Secondary outcomes (3)
Waist Circumference
Change in waist circumference from baseline to week 12
Measured: 12 Weeks
Smoking Abstinence Rates
prolonged smoking abstinence at week 12
Measured: 12 weeks
BMI
Change in BMI from baseline to week 12
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startSep 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan T. Hurt, M.D., Ph.D., Mayo Clinic
- Investigators
- Ryan Hurt, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393547
- Sponsor's protocol ID
- 13-007240
- Status last verified
- May 2017
- First submitted
- 13 Mar 2015
- Last updated
- 6 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 27852796
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lorcaserin for Preventing Weight Gain Among Smokers Receiving Varenicline: A Pilot Study
- ClinicalTrials.gov ID
- NCT02393547
- Acronym / sponsor ID
- 13-007240
- Conditions
- Tobacco Use Disorder, Weight Gain
- Keywords
- obesity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Posted 6 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Varenicline + Lorcaserin | Experimental | Drug: Varenicline, Drug: LorcaserinOpen label all subjects receive both Varenicline and Lorcaserin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥18 years and ≤65 years of age;
- smoked ≥10 cigarettes/day for the past 6 months;
- BMI of 27-40 kg/m2;
- resides within the Olmsted County area;
- motivated to stop smoking;
Key exclusion criteria (19 listed)
- 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.");
- current moderate or severe depression as assessed by a score of ≥16 on the Center for Epidemiologic Studies-Depression (CES-D);
- a lifetime history of 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VareniclineAlso: ChantixAll subjects receive Varenicline | Drug | Varenicline + Lorcaserin |
| LorcaserinAlso: BelviqAll subjects receive Lorcaserin | Drug | Varenicline + Lorcaserin |
Primary outcome
Post Cessation Weight Change
Time frame: 12 weeks
change in weight from baseline to week 12
3 secondary outcomes
Waist Circumference
Time frame: 12 Weeks
Smoking Abstinence Rates
Time frame: 12 weeks
BMI
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27852796Hurt 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.
Related trials for Tobacco Use Disorder
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
Not yet recruitingObservational study
Neurostructural and Biochemical Signatures of Tobacco Smoking in Mood Disorders
Major Depressive Disorder, Bipolar Disorder
Recruiting
EFFECTIVENESS OF VOLITIONAL HELP SHEETS AS AN ADJUNCT TO TREATMENT TO PROMOTE BEHAVIOR CHANGE: A PILOT STUDY ON SMOKING
Tobacco Dependence
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Hurt, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Varenicline and Lorcaserin in people with Tobacco Use Disorder and Weight Gain, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Cessation Weight Change (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02393547, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.