Addressing Post Cessation Weight Gain

NCT ID: NCT02412631

Last Updated: 2021-06-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-15
• Study Completion Date: 2020-04-17

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.

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.

Conditions

Obesity; Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Varenicline plus placebo

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

Group Type: PLACEBO_COMPARATOR

Varenicline

Intervention Type: DRUG

Chantix is an FDA approved medication for smoking cessation

Placebo

Intervention Type: DRUG

Placebo for lorcaserin

Varenicline plus lorcaserin

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

Group Type: EXPERIMENTAL

lorcaserin

Intervention Type: DRUG

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

Varenicline

Intervention Type: DRUG

Chantix is an FDA approved medication for smoking cessation

Interventions

lorcaserin

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

Intervention Type: DRUG

Varenicline

Chantix is an FDA approved medication for smoking cessation

Intervention Type: DRUG

Placebo

Placebo for lorcaserin

Intervention Type: DRUG

Other Intervention Names

Belviq; Chantix

Eligibility Criteria

Inclusion Criteria

Subjects will be considered for inclusion if they meet all of the following

1. ≥18 years and ≤65 years of age;

2. smoked ≥10 cigarettes/day for the past 6 months;

3. Body Mass Index of 27-39.9 kg/m2;

4. motivated to stop smoking;

5. weight concerned as shown with the Weight Concern Scale;

6. able to participate fully in all aspects of the study;

7. understand and signed the study informed consent.

8. 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:

1. 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.");

2. current moderate or severe depression as assessed by a score of ≥16 on the Center for Epidemiology Studies-Depression;

3. a lifetime history of psychosis, 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. 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

10. 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);

11. uncontrolled hypertension (systolic >160 mm Hg and/or diastolic >100 mm Hg) documented on 2 separate occasions;

12. current use of medications known to interact with varenicline or lorcaserin. These can include benzodiazepines, narcotics, anti-epileptics;

13. another household member or relative participating in the study;

14. known diabetes;

15. a known allergy to varenicline or lorcaserin.

16. 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.

17. Has an unstable medical condition as determined by the physician investigator

18. 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.

19. Subject currently has cancer [excluding non-melanoma skin cancer] not in remission

20. Known history of seizures

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Ryan T. Hurt, M.D., Ph.D.

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryan T Hurt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36160639 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

1K23DA037299-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14-005682

Identifier Type: OTHER

Identifier Source: secondary_id

15-005230

Identifier Type: -

Identifier Source: org_study_id