Trial · NCT02412631

Addressing Post Cessation Weight Gain

NCT02412631, Phase 2, Phase 3, Terminated, Mayo Clinic; results first posted 2021-06-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Addressing Post Cessation Weight Gain. Trials, record NCT02412631. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02412631

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Addressing Post Cessation Weight Gain
NCT number: NCT02412631
Status: Terminated
Phases: Phase 2, Phase 3
Enrollment: 84 participants, actual
Lead sponsor: Mayo Clinic
Conditions: Obesity, Smoking Cessation
Interventions: lorcaserin, Varenicline, Placebo
First posted: 2015-04-09
Last updated: 2021-06-10
Results first posted: 2021-06-10

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Post Cessation Weight Gain (kg)	24 weeks	weight (kg) change from baseline to week 24 among subjects who meet criteria for prolonged smoking abstinence at week 24
Secondary	BMI	24 weeks	BMI change from baseline to week 24
Secondary	Smoking Abstinence	24 weeks	Lorcaserin combined with open label varenicline will be evaluated for improved smoking abstinence compared to placebo
Secondary	Waist Circumference	24 weeks	Waist Circumference change from baseline to week 24
Secondary	Fat Mass	24 weeks	Body Fat difference from baseline to week 24.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Post Cessation Weight Gain (kg)	24 weeks	Restricted to those who met criteria for prolonged abstinence at week 24.	kg	MEAN
SECONDARY	BMI	24 weeks	Restricted to those who met criteria for prolonged abstinence at week 24.	kg/m^2	MEAN
SECONDARY	Smoking Abstinence	24 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Waist Circumference	24 weeks	Restricted to those who met criteria for prolonged abstinence at week 24.	cm	MEAN
SECONDARY	Fat Mass	24 weeks	Restricted to those who met criteria for prolonged abstinence at week 24.	kg	MEAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Post Cessation Weight Gain (kg)	Varenicline Plus Placebo	0.7	Standard Deviation 8.38	kg
Post Cessation Weight Gain (kg)	Varenicline Plus Lorcaserin	2.2	Standard Deviation 2.07	kg
BMI	Varenicline Plus Placebo	0.5	Standard Deviation 2.91	kg/m^2
BMI	Varenicline Plus Lorcaserin	0.8	Standard Deviation 0.72	kg/m^2
Smoking Abstinence	Varenicline Plus Placebo	13		Participants
Smoking Abstinence	Varenicline Plus Lorcaserin	8		Participants
Waist Circumference	Varenicline Plus Placebo	0.8	Standard Deviation 7.60	cm
Waist Circumference	Varenicline Plus Lorcaserin	-0.1	Standard Deviation 2.97	cm
Fat Mass	Varenicline Plus Placebo	0.4	Standard Deviation 7.12	kg
Fat Mass	Varenicline Plus Lorcaserin	2.2	Standard Deviation 2.74	kg

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Varenicline Plus Placebo	44
Overall Study	STARTED	Varenicline Plus Lorcaserin	40
Overall Study	COMPLETED	Varenicline Plus Placebo	18
Overall Study	COMPLETED	Varenicline Plus Lorcaserin	16
Overall Study	NOT COMPLETED	Varenicline Plus Placebo	26
Overall Study	NOT COMPLETED	Varenicline Plus Lorcaserin	24

Source ClinicalTrials.gov

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Headache	Nervous system disorders	Varenicline Plus Placebo	4	44
other	Headache	Nervous system disorders	Varenicline Plus Lorcaserin	2	40
other	Constipation	Gastrointestinal disorders	Varenicline Plus Placebo	3	44
other	Constipation	Gastrointestinal disorders	Varenicline Plus Lorcaserin	5	40
other	Fatigue	General disorders	Varenicline Plus Placebo	2	44
other	Fatigue	General disorders	Varenicline Plus Lorcaserin	5	40
other	GI	Gastrointestinal disorders	Varenicline Plus Placebo	5	44
other	GI	Gastrointestinal disorders	Varenicline Plus Lorcaserin	4	40
other	Nausea	Gastrointestinal disorders	Varenicline Plus Placebo	8	44
other	Nausea	Gastrointestinal disorders	Varenicline Plus Lorcaserin	5	40

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Varenicline Plus Placebo	0	44
Total, all-cause mortality	Varenicline Plus Lorcaserin	0	40
Total, other adverse events	Varenicline Plus Placebo	21	44
Total, other adverse events	Varenicline Plus Lorcaserin	18	40
Total, serious adverse events	Varenicline Plus Placebo	0	44
Total, serious adverse events	Varenicline Plus Lorcaserin	0	40

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36160639	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
K23DA037299	Varenicline and lorcaserin for smoking cessation and weight gain prevention	HURT, RYAN THOMAS	MAYO CLINIC ROCHESTER	NATIONAL INSTITUTE ON DRUG ABUSE	2015 to 2019

Source NIH RePORTER

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Varenicline Plus Placebo vs Varenicline Plus Lorcaserin: Smoking Abstinence	Trial comparisons
Varenicline Plus Placebo vs Varenicline Plus Lorcaserin: deaths from any cause	Trial comparisons
Varenicline Plus Placebo vs Varenicline Plus Lorcaserin: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02412631

GET https://conductscience.org/api/trials/v1/NCT02412631/registered

API reference For AI assistants