Addressing Post Cessation Weight Gain

NCT02412631 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: 15-0052301K23DA037299-01A114-005682
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Some individuals smoke with the perception that smoking helps control body weight. Smokers gain an average of as much as 10 pounds in the months following smoking abstinence, with heavier and more-dependent smokers gaining more weight. T The Mayo Clinic Nicotine Research Program will randomize 100 nondiabetic, overweight or obese adult smokers to active lorcaserin or placebo for 24 weeks; all of the subjects will receive open-label varenicline for 12 weeks. The purpose of this study is to assess the efficacy of a 24-week course of lorcaserin for decreasing weight gain after stopping smoking.

Conditions

Obesity; Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Post Cessation Weight Gain (kg)

  weight (kg) change from baseline to week 24 among subjects who meet criteria for prolonged smoking abstinence at week 24

  24 weeks

Secondary Outcomes (4)

• BMI

  24 weeks

• Smoking Abstinence

  24 weeks

• Waist Circumference

  24 weeks

• Fat Mass

  24 weeks

Study Arms (2)

Varenicline plus placebo

PLACEBO COMPARATOR

Subjects will receive open label varenicline (12 weeks) plus a placebo for lorcaserin (24 weeks)

Drug: Varenicline; Drug: Placebo

Varenicline plus lorcaserin

EXPERIMENTAL

Subjects will receive open label varenicline (12 weeks) plus lorcaserin (24 weeks)

Drug: lorcaserin; Drug: Varenicline

Interventions

lorcaserin DRUG

lorcaserin is an FDA-approved weight loss medication for overweight and obese patients

Also known as: Belviq

Varenicline plus lorcaserin

Varenicline DRUG

Chantix is an FDA approved medication for smoking cessation

Also known as: Chantix

Varenicline plus lorcaserin; Varenicline plus placebo

Placebo DRUG

Placebo for lorcaserin

Varenicline plus placebo

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;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Hurt RT, Croghan IT, Schroeder DR, Choi DS, Fischer K, Fokken S, Ebbert JO. Varenicline and Lorcaserin for Smoking Cessation and Weight Gain Prevention: A Randomized Clinical Trial. Mayo Clin Proc Innov Qual Outcomes. 2022 Sep 21;6(5):465-474. doi: 10.1016/j.mayocpiqo.2022.01.004. eCollection 2022 Oct.

  PMID: 36160639 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Obesity; Smoking Cessation

Interventions

lorcaserin; Varenicline

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Ryan Hurt
• Organization: Mayo Clinic

gimresearchstudies@mayo.edu

(507) 284-2511

Study Officials

• Ryan T Hurt, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: April 9, 2015
• Study Start: June 15, 2016
• Primary Completion: April 17, 2020
• Study Completion: April 17, 2020
• Last Updated: June 10, 2021
• Results First Posted: June 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)