Trial Outcomes & Findings for Naltrexone and Varenicline: Weight Gain and Tolerability in Cigarette Smokers (NCT NCT00502216)

NCT ID: NCT00502216

Last Updated: 2018-01-17

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 40 participants
• Primary outcome timeframe: baseline and 12 weeks
• Results posted on: 2018-01-17

Participant Flow

Participant milestones

Measure	Varenicline + Naltrexone Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day	Varenicline + Placebo Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
Overall Study STARTED	21	19
Overall Study COMPLETED	21	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Naltrexone and Varenicline: Weight Gain and Tolerability in Cigarette Smokers

Baseline characteristics by cohort

Measure	Varenicline + Naltrexone n=21 Participants Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day	Varenicline + Placebo n=19 Participants Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day	Total n=40 Participants Total of all reporting groups
Age, Continuous	50.29 years STANDARD_DEVIATION 11.08 • n=93 Participants	42.42 years STANDARD_DEVIATION 9.57 • n=4 Participants	46.55 years STANDARD_DEVIATION 11.00 • n=27 Participants
Sex: Female, Male Female	15 Participants n=93 Participants	12 Participants n=4 Participants	27 Participants n=27 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	7 Participants n=4 Participants	13 Participants n=27 Participants
Region of Enrollment United States	21 participants n=93 Participants	19 participants n=4 Participants	40 participants n=27 Participants

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: Subpopulation of participants who reported quitting smoking

Outcome measures

Measure	Varenicline + Naltrexone n=17 Participants Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day	Varenicline + Placebo n=11 Participants Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
Weight Gain in Treatment Completers	3.35 Pounds Standard Deviation 6.61	4.14 Pounds Standard Deviation 5.15

SECONDARY outcome

Timeframe: 4 weeks

Population: Analyzed are those that remained abstinent for last 4 weeks of treatment

Outcome measures

Measure	Varenicline + Naltrexone n=3 Participants Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day	Varenicline + Placebo n=3 Participants Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
Weight Gain in Participants Who Are Continuously Abstinent for the Last 4 Weeks of Treatment	0 pounds Standard Deviation 4.36	7.67 pounds Standard Deviation 2.31

SECONDARY outcome

Timeframe: 11 weeks

Tolerability was measured by tracking adverse events. These data are reported in detail in the adverse events section. Presented are an unduplicated count of participants that experienced at least 1 adverse event.

Outcome measures

Measure	Varenicline + Naltrexone n=21 Participants Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day	Varenicline + Placebo n=19 Participants Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
Tolerability of the Combination of 25 mg Naltrexone and 2 mg Varenicline	10 Participants	4 Participants

Adverse Events

Varenicline + Naltrexone

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Varenicline + Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Varenicline + Naltrexone n=21 participants at risk Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day	Varenicline + Placebo n=19 participants at risk Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
General disorders Nausea	28.6% 6/21	— 0/0
Psychiatric disorders Anxiety	14.3% 3/21	5.3% 1/19
Gastrointestinal disorders Constipation	14.3% 3/21	5.3% 1/19
General disorders Fatigue	19.0% 4/21	0.00% 0/19
Psychiatric disorders Depression	14.3% 3/21	0.00% 0/19
Gastrointestinal disorders Flatulence	9.5% 2/21	5.3% 1/19
Psychiatric disorders Insomnia	14.3% 3/21	0.00% 0/19
General disorders Joint pain	9.5% 2/21	5.3% 1/19
Psychiatric disorders Sleepiness	9.5% 2/21	0.00% 0/19
Psychiatric disorders Vivid dreams	9.5% 2/21	0.00% 0/19
Gastrointestinal disorders Acid reflux	0.00% 0/21	5.3% 1/19
General disorders Other	9.5% 2/21	5.3% 1/19
Metabolism and nutrition disorders Decreased Appetite	4.8% 1/21	0.00% 0/19
Nervous system disorders Dizzyness	4.8% 1/21	0.00% 0/19
General disorders Drowsiness	4.8% 1/21	0.00% 0/19
General disorders Dry Mouth	4.8% 1/21	0.00% 0/19
General disorders Headache	4.8% 1/21	0.00% 0/19
Metabolism and nutrition disorders Increased Appetite	4.8% 1/21	0.00% 0/19
General disorders Nightmares	4.8% 1/21	0.00% 0/19
General disorders Sweating	4.8% 1/21	0.00% 0/19
Gastrointestinal disorders Vomiting	4.8% 1/21	0.00% 0/19

Additional Information

Benjamin Toll, Ph.D.

Yale University School of Medicine

Phone: 203-974-5767

Email: benjamin.toll@yale.edu

Results disclosure agreements

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