Lorcaserin for Preventing Weight Gain Among Smokers

NCT02393547 | Completed Phase 1 Results DMC

• 1 other identifier: 13-007240
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorder; Weight Gain

Keywords

obesity

Outcome Measures

Primary Outcomes (1)

• Post Cessation Weight Change

  change in weight from baseline to week 12

  12 weeks

Secondary Outcomes (3)

• Waist Circumference

  12 Weeks

• Smoking Abstinence Rates

  12 weeks

• BMI

  12 weeks

Study Arms (1)

Varenicline + Lorcaserin

EXPERIMENTAL

Open label all subjects receive both Varenicline and Lorcaserin

Drug: Varenicline; Drug: Lorcaserin

Interventions

Varenicline DRUG

All subjects receive Varenicline

Also known as: Chantix

Varenicline + Lorcaserin

Lorcaserin DRUG

All subjects receive Lorcaserin

Also known as: Belviq

Varenicline + Lorcaserin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 27852796 RESULT

MeSH Terms

Conditions

Tobacco Use Disorder; Weight Gain; Obesity

Interventions

Varenicline; lorcaserin

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Ryan T. Hurt, MD
• Organization: Mayo Clinic

nicotineresearch@mayo.edu

507-266-1944

Study Officials

• Ryan Hurt, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 13, 2015
• First Posted: March 19, 2015
• Study Start: September 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 6, 2017
• Results First Posted: June 6, 2017

Record last verified: 2017-05

Locations

US (1)