Trial Outcomes & Findings for Addressing Post Cessation Weight Gain (NCT NCT02412631)

NCT ID: NCT02412631

Last Updated: 2021-06-10

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 84 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2021-06-10

Participant Flow

Recruitment took place between June 16th, 2016 to January 22nd, 2020. Recruitment was in three phases: initial phone pre-screen, followed by a consent visit and study screen, and finally a randomization visit. All visits took place at a medical clinic.

Participant milestones

Measure	Varenicline Plus Placebo Subjects will receive open label varenicline (12 weeks) plus a placebo for lorcaserin (24 weeks) Varenicline: Chantix is an FDA approved medication for smoking cessation Placebo: Placebo for lorcaserin	Varenicline Plus Lorcaserin Subjects will receive open label varenicline (12 weeks) plus lorcaserin (24 weeks) lorcaserin: lorcaserin is an FDA-approved weight loss medication for overweight and obese patients Varenicline: Chantix is an FDA approved medication for smoking cessation
Overall Study STARTED	44	40
Overall Study COMPLETED	18	16
Overall Study NOT COMPLETED	26	24

Reasons for withdrawal

Measure	Varenicline Plus Placebo Subjects will receive open label varenicline (12 weeks) plus a placebo for lorcaserin (24 weeks) Varenicline: Chantix is an FDA approved medication for smoking cessation Placebo: Placebo for lorcaserin	Varenicline Plus Lorcaserin Subjects will receive open label varenicline (12 weeks) plus lorcaserin (24 weeks) lorcaserin: lorcaserin is an FDA-approved weight loss medication for overweight and obese patients Varenicline: Chantix is an FDA approved medication for smoking cessation
Overall Study Adverse Event	1	2
Overall Study Lost to Follow-up	5	9
Overall Study Withdrawal by Subject	9	3
Overall Study Early stop by FDA	5	2
Overall Study Unspecified reason	6	8

Baseline Characteristics

Addressing Post Cessation Weight Gain

Baseline characteristics by cohort

Measure	Varenicline Plus Placebo n=44 Participants Subjects will receive open label varenicline (12 weeks) plus a placebo for lorcaserin (24 weeks) Varenicline: Chantix is an FDA approved medication for smoking cessation Placebo: Placebo for lorcaserin	Varenicline Plus Lorcaserin n=40 Participants Subjects will receive open label varenicline (12 weeks) plus lorcaserin (24 weeks) lorcaserin: lorcaserin is an FDA-approved weight loss medication for overweight and obese patients Varenicline: Chantix is an FDA approved medication for smoking cessation	Total n=84 Participants Total of all reporting groups
Age, Continuous	41.3 years STANDARD_DEVIATION 9.05 • n=5 Participants	43.4 years STANDARD_DEVIATION 10.98 • n=7 Participants	42.3 years STANDARD_DEVIATION 10.01 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	25 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=5 Participants	40 Participants n=7 Participants	82 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	41 Participants n=5 Participants	37 Participants n=7 Participants	78 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Cigarettes per day	17.2 cigarettes per day STANDARD_DEVIATION 5.59 • n=5 Participants	17.9 cigarettes per day STANDARD_DEVIATION 5.96 • n=7 Participants	17.5 cigarettes per day STANDARD_DEVIATION 5.75 • n=5 Participants
Baseline Weight	91.8 kg STANDARD_DEVIATION 15.46 • n=5 Participants	93.4 kg STANDARD_DEVIATION 14.7 • n=7 Participants	92.6 kg STANDARD_DEVIATION 15.03 • n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Restricted to those who met criteria for prolonged abstinence at week 24.

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

Outcome measures

Measure	Varenicline Plus Placebo n=13 Participants Subjects will receive open label varenicline (12 weeks) plus a placebo for lorcaserin (24 weeks) Varenicline: Chantix is an FDA approved medication for smoking cessation Placebo: Placebo for lorcaserin	Varenicline Plus Lorcaserin n=8 Participants Subjects will receive open label varenicline (12 weeks) plus lorcaserin (24 weeks) lorcaserin: lorcaserin is an FDA-approved weight loss medication for overweight and obese patients Varenicline: Chantix is an FDA approved medication for smoking cessation
Post Cessation Weight Gain (kg)	0.7 kg Standard Deviation 8.38	2.2 kg Standard Deviation 2.07

SECONDARY outcome

Timeframe: 24 weeks

Population: Restricted to those who met criteria for prolonged abstinence at week 24.

BMI change from baseline to week 24

Outcome measures

Measure	Varenicline Plus Placebo n=13 Participants Subjects will receive open label varenicline (12 weeks) plus a placebo for lorcaserin (24 weeks) Varenicline: Chantix is an FDA approved medication for smoking cessation Placebo: Placebo for lorcaserin	Varenicline Plus Lorcaserin n=8 Participants Subjects will receive open label varenicline (12 weeks) plus lorcaserin (24 weeks) lorcaserin: lorcaserin is an FDA-approved weight loss medication for overweight and obese patients Varenicline: Chantix is an FDA approved medication for smoking cessation
BMI	0.5 kg/m^2 Standard Deviation 2.91	0.8 kg/m^2 Standard Deviation 0.72

SECONDARY outcome

Timeframe: 24 weeks

Lorcaserin combined with open label varenicline will be evaluated for improved smoking abstinence compared to placebo

Outcome measures

Measure	Varenicline Plus Placebo n=44 Participants Subjects will receive open label varenicline (12 weeks) plus a placebo for lorcaserin (24 weeks) Varenicline: Chantix is an FDA approved medication for smoking cessation Placebo: Placebo for lorcaserin	Varenicline Plus Lorcaserin n=40 Participants Subjects will receive open label varenicline (12 weeks) plus lorcaserin (24 weeks) lorcaserin: lorcaserin is an FDA-approved weight loss medication for overweight and obese patients Varenicline: Chantix is an FDA approved medication for smoking cessation
Smoking Abstinence	13 Participants	8 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Restricted to those who met criteria for prolonged abstinence at week 24.

Waist Circumference change from baseline to week 24

Outcome measures

Measure	Varenicline Plus Placebo n=13 Participants Subjects will receive open label varenicline (12 weeks) plus a placebo for lorcaserin (24 weeks) Varenicline: Chantix is an FDA approved medication for smoking cessation Placebo: Placebo for lorcaserin	Varenicline Plus Lorcaserin n=8 Participants Subjects will receive open label varenicline (12 weeks) plus lorcaserin (24 weeks) lorcaserin: lorcaserin is an FDA-approved weight loss medication for overweight and obese patients Varenicline: Chantix is an FDA approved medication for smoking cessation
Waist Circumference	0.8 cm Standard Deviation 7.60	-0.1 cm Standard Deviation 2.97

SECONDARY outcome

Timeframe: 24 weeks

Population: Restricted to those who met criteria for prolonged abstinence at week 24.

Body Fat difference from baseline to week 24.

Outcome measures

Measure	Varenicline Plus Placebo n=13 Participants Subjects will receive open label varenicline (12 weeks) plus a placebo for lorcaserin (24 weeks) Varenicline: Chantix is an FDA approved medication for smoking cessation Placebo: Placebo for lorcaserin	Varenicline Plus Lorcaserin n=8 Participants Subjects will receive open label varenicline (12 weeks) plus lorcaserin (24 weeks) lorcaserin: lorcaserin is an FDA-approved weight loss medication for overweight and obese patients Varenicline: Chantix is an FDA approved medication for smoking cessation
Fat Mass	0.4 kg Standard Deviation 7.12	2.2 kg Standard Deviation 2.74

Adverse Events

Varenicline Plus Placebo

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Varenicline Plus Lorcaserin

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Varenicline Plus Placebo n=44 participants at risk Subjects will receive open label varenicline (12 weeks) plus a placebo for lorcaserin (24 weeks) Varenicline: Chantix is an FDA approved medication for smoking cessation Placebo: Placebo for lorcaserin	Varenicline Plus Lorcaserin n=40 participants at risk Subjects will receive open label varenicline (12 weeks) plus lorcaserin (24 weeks) lorcaserin: lorcaserin is an FDA-approved weight loss medication for overweight and obese patients Varenicline: Chantix is an FDA approved medication for smoking cessation
Nervous system disorders Headache	9.1% 4/44 • Adverse events (AE) were collected throughout the 24 week study period. Reported AEs were included in this section.	5.0% 2/40 • Adverse events (AE) were collected throughout the 24 week study period. Reported AEs were included in this section.
Gastrointestinal disorders Constipation	6.8% 3/44 • Adverse events (AE) were collected throughout the 24 week study period. Reported AEs were included in this section.	12.5% 5/40 • Adverse events (AE) were collected throughout the 24 week study period. Reported AEs were included in this section.
General disorders Fatigue	4.5% 2/44 • Adverse events (AE) were collected throughout the 24 week study period. Reported AEs were included in this section.	12.5% 5/40 • Adverse events (AE) were collected throughout the 24 week study period. Reported AEs were included in this section.
Gastrointestinal disorders GI	11.4% 5/44 • Adverse events (AE) were collected throughout the 24 week study period. Reported AEs were included in this section.	10.0% 4/40 • Adverse events (AE) were collected throughout the 24 week study period. Reported AEs were included in this section.
Gastrointestinal disorders Nausea	18.2% 8/44 • Adverse events (AE) were collected throughout the 24 week study period. Reported AEs were included in this section.	12.5% 5/40 • Adverse events (AE) were collected throughout the 24 week study period. Reported AEs were included in this section.
General disorders Sleep disorders	20.5% 9/44 • Adverse events (AE) were collected throughout the 24 week study period. Reported AEs were included in this section.	17.5% 7/40 • Adverse events (AE) were collected throughout the 24 week study period. Reported AEs were included in this section.
Nervous system disorders Mood	0.00% 0/44 • Adverse events (AE) were collected throughout the 24 week study period. Reported AEs were included in this section.	7.5% 3/40 • Adverse events (AE) were collected throughout the 24 week study period. Reported AEs were included in this section.
General disorders Dry Mouth	0.00% 0/44 • Adverse events (AE) were collected throughout the 24 week study period. Reported AEs were included in this section.	2.5% 1/40 • Adverse events (AE) were collected throughout the 24 week study period. Reported AEs were included in this section.

Additional Information

Dr. Ryan Hurt

Mayo Clinic

Phone: (507) 284-2511

Email: gimresearchstudies@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place