Trial Outcomes & Findings for Varenicline for Smoking Cessation in Heavy Drinking Smokers (NCT NCT00860028)

Last Updated: 2021-08-13

Results Overview

Compares the number of participants who reported no smoking, not even a puff, from the quit date through until the end of treatment (i.e., last 4 weeks of treatment) in the varenicline versus placebo pretreatment conditions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Last 4 weeks of treatment

Results posted on

2021-08-13

Participant Flow

Outpatient research clinic

Prior to randomization, inclusion and exclusion criteria were assessed. Reasons for exclusion included health problems, not meeting drinking/smoking criteria, other drug use, and depression requiring treatment.

Participant milestones

Participant milestones
Measure	Extended Varenicline Pretreatment Arm 1 (Experimental) = 3 weeks varenicline (Chantix) 1 mg oral tablet twice per day pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment.	Short-term Varenicline Pretreatment Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date.
Placebo Controlled Pretreatment Period STARTED	15	15
Placebo Controlled Pretreatment Period COMPLETED	13	14
Placebo Controlled Pretreatment Period NOT COMPLETED	2	1
Smoking Cessation Phase STARTED	13	14
Smoking Cessation Phase COMPLETED	13	12
Smoking Cessation Phase NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Extended Varenicline Pretreatment Arm 1 (Experimental) = 3 weeks varenicline (Chantix) 1 mg oral tablet twice per day pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment.	Short-term Varenicline Pretreatment Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date.
Placebo Controlled Pretreatment Period No longer interested in treatment	2	1

Baseline Characteristics

Varenicline for Smoking Cessation in Heavy Drinking Smokers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Extended Varenicline Pretreatment n=15 Participants Arm 1 (Experimental) = 3 weeks varenicline (Chantix) 1 mg oral tablet twice per day pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment	Short Varenicline Pretreatment (Placebo) n=15 Participants Arm 2 (Experimental) = 3 weeks placebo pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	42.87 years STANDARD_DEVIATION 8.52 • n=5 Participants	43.47 years STANDARD_DEVIATION 7.99 • n=7 Participants	43.17 years STANDARD_DEVIATION 8.12 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Last 4 weeks of treatment

Population: All participants were included in the analysis, assuming an intention to treat method.

Outcome measures

Outcome measures
Measure	Extended Varenicline Pretreatment n=15 Participants Arm 1 (Experimental) = 4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day pretreatment + 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment following the smoking quit date	Short-term Varenicline Pretreatment n=15 Participants Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date.
Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions.	4 Participants	2 Participants

PRIMARY outcome

Timeframe: First 3 weeks (pretreatment)

Population: All participants were included in the analysis, assuming an intention to treat method.

Compares the mean percentage of heavy drinking days over the 3-week placebo-controlled pretreatment phase comparing participants in the extended varenicline pretreatment versus the short-term varenicline pretreatment conditions. Heavy drinking defined as consuming 4 or more drinks per occasion for women and 5 or more drinks per occasion for men. Drinking in the final week of pretreatment prior to the quit-date is not included because both groups were receiving active varenicline during this period.

Outcome measures

Outcome measures
Measure	Extended Varenicline Pretreatment n=15 Participants Arm 1 (Experimental) = 4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day pretreatment + 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment following the smoking quit date	Short-term Varenicline Pretreatment n=15 Participants Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date.
Mean Percentage of Heavy Drinking Days Comparing Participants in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions	22.7 percentage of heavy drinking days Standard Deviation 17.5	38.0 percentage of heavy drinking days Standard Deviation 31.2

SECONDARY outcome

Timeframe: First 3 weeks (pretreatment)

Population: All participants were included in the analysis, assuming an intention to treat method.

Compares the number of participants who reported an adverse event in the extended varenicline pretreatment versus short-term varenicline pretreatment conditions during the 3-week placebo controlled pretreatment phase

Outcome measures

Outcome measures
Measure	Extended Varenicline Pretreatment n=15 Participants Arm 1 (Experimental) = 4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day pretreatment + 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment following the smoking quit date	Short-term Varenicline Pretreatment n=15 Participants Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date.
Number of Participants Who Reported an Adverse Event in the Varenicline Pretreatment Versus Placebo Pretreatment Conditions	10 Number of participants	3 Number of participants

Adverse Events

Extended Varenicline Pretreatment

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Short Varenicline Pretreatment (Placebo)

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Stephanie O'Malley

Yale School of Medicine

Phone: 203-974-7590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Extended Varenicline Pretreatment n=15 participants at risk Arm 1 (Experimental) = 3 weeks varenicline (Chantix) 1 mg oral tablet twice per day pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment	Short Varenicline Pretreatment (Placebo) n=15 participants at risk Arm 2 (Experimental) = 3 weeks placebo pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment
Gastrointestinal disorders Constipation	6.7% 1/15 • Number of events 1 • Adverse events also assessed post quitting smoking during the open label phase of the study.	26.7% 4/15 • Number of events 4 • Adverse events also assessed post quitting smoking during the open label phase of the study.
Gastrointestinal disorders Abdominal Pain	26.7% 4/15 • Number of events 4 • Adverse events also assessed post quitting smoking during the open label phase of the study.	46.7% 7/15 • Number of events 7 • Adverse events also assessed post quitting smoking during the open label phase of the study.
Gastrointestinal disorders Acid Reflux	26.7% 4/15 • Number of events 4 • Adverse events also assessed post quitting smoking during the open label phase of the study.	46.7% 7/15 • Number of events 7 • Adverse events also assessed post quitting smoking during the open label phase of the study.
Psychiatric disorders Anxiety	26.7% 4/15 • Number of events 4 • Adverse events also assessed post quitting smoking during the open label phase of the study.	26.7% 4/15 • Number of events 4 • Adverse events also assessed post quitting smoking during the open label phase of the study.
Eye disorders Blurred Vision	6.7% 1/15 • Number of events 1 • Adverse events also assessed post quitting smoking during the open label phase of the study.	6.7% 1/15 • Number of events 1 • Adverse events also assessed post quitting smoking during the open label phase of the study.
General disorders Decreased Appetite	6.7% 1/15 • Number of events 1 • Adverse events also assessed post quitting smoking during the open label phase of the study.	20.0% 3/15 • Number of events 3 • Adverse events also assessed post quitting smoking during the open label phase of the study.
Psychiatric disorders Depression	20.0% 3/15 • Number of events 3 • Adverse events also assessed post quitting smoking during the open label phase of the study.	20.0% 3/15 • Number of events 3 • Adverse events also assessed post quitting smoking during the open label phase of the study.
Gastrointestinal disorders Diarrhea	26.7% 4/15 • Number of events 4 • Adverse events also assessed post quitting smoking during the open label phase of the study.	26.7% 4/15 • Number of events 4 • Adverse events also assessed post quitting smoking during the open label phase of the study.
Nervous system disorders Dizziness	13.3% 2/15 • Number of events 2 • Adverse events also assessed post quitting smoking during the open label phase of the study.	26.7% 4/15 • Number of events 4 • Adverse events also assessed post quitting smoking during the open label phase of the study.
General disorders Dry Mouth	26.7% 4/15 • Number of events 4 • Adverse events also assessed post quitting smoking during the open label phase of the study.	26.7% 4/15 • Number of events 4 • Adverse events also assessed post quitting smoking during the open label phase of the study.
General disorders Dysgeusia	26.7% 4/15 • Number of events 4 • Adverse events also assessed post quitting smoking during the open label phase of the study.	46.7% 7/15 • Number of events 7 • Adverse events also assessed post quitting smoking during the open label phase of the study.
Vascular disorders Edema	0.00% 0/15 • Adverse events also assessed post quitting smoking during the open label phase of the study.	13.3% 2/15 • Number of events 2 • Adverse events also assessed post quitting smoking during the open label phase of the study.
General disorders Fatigue	53.3% 8/15 • Number of events 8 • Adverse events also assessed post quitting smoking during the open label phase of the study.	40.0% 6/15 • Number of events 6 • Adverse events also assessed post quitting smoking during the open label phase of the study.
Gastrointestinal disorders Flatulence	40.0% 6/15 • Number of events 6 • Adverse events also assessed post quitting smoking during the open label phase of the study.	40.0% 6/15 • Number of events 6 • Adverse events also assessed post quitting smoking during the open label phase of the study.
General disorders Headache	33.3% 5/15 • Number of events 5 • Adverse events also assessed post quitting smoking during the open label phase of the study.	53.3% 8/15 • Number of events 8 • Adverse events also assessed post quitting smoking during the open label phase of the study.
Metabolism and nutrition disorders Increased Appetite	66.7% 10/15 • Number of events 10 • Adverse events also assessed post quitting smoking during the open label phase of the study.	46.7% 7/15 • Number of events 7 • Adverse events also assessed post quitting smoking during the open label phase of the study.
Gastrointestinal disorders Increased Bowel	13.3% 2/15 • Number of events 2 • Adverse events also assessed post quitting smoking during the open label phase of the study.	33.3% 5/15 • Number of events 5 • Adverse events also assessed post quitting smoking during the open label phase of the study.
Gastrointestinal disorders Indigestion	40.0% 6/15 • Number of events 6 • Adverse events also assessed post quitting smoking during the open label phase of the study.	20.0% 3/15 • Number of events 3 • Adverse events also assessed post quitting smoking during the open label phase of the study.
General disorders Insomnia	46.7% 7/15 • Number of events 7 • Adverse events also assessed post quitting smoking during the open label phase of the study.	53.3% 8/15 • Number of events 8 • Adverse events also assessed post quitting smoking during the open label phase of the study.
Skin and subcutaneous tissue disorders Itching	26.7% 4/15 • Number of events 4 • Adverse events also assessed post quitting smoking during the open label phase of the study.	26.7% 4/15 • Number of events 4 • Adverse events also assessed post quitting smoking during the open label phase of the study.
Musculoskeletal and connective tissue disorders Joint Pain	13.3% 2/15 • Number of events 2 • Adverse events also assessed post quitting smoking during the open label phase of the study.	26.7% 4/15 • Number of events 4 • Adverse events also assessed post quitting smoking during the open label phase of the study.
Respiratory, thoracic and mediastinal disorders Labored Breathing	13.3% 2/15 • Number of events 2 • Adverse events also assessed post quitting smoking during the open label phase of the study.	13.3% 2/15 • Number of events 2 • Adverse events also assessed post quitting smoking during the open label phase of the study.
General disorders Lethargy	33.3% 5/15 • Number of events 5 • Adverse events also assessed post quitting smoking during the open label phase of the study.	33.3% 5/15 • Number of events 5 • Adverse events also assessed post quitting smoking during the open label phase of the study.
Reproductive system and breast disorders Missed Period	6.7% 1/15 • Number of events 1 • Adverse events also assessed post quitting smoking during the open label phase of the study.	6.7% 1/15 • Number of events 1 • Adverse events also assessed post quitting smoking during the open label phase of the study.
Gastrointestinal disorders Nausea	60.0% 9/15 • Number of events 9 • Adverse events also assessed post quitting smoking during the open label phase of the study.	46.7% 7/15 • Number of events 7 • Adverse events also assessed post quitting smoking during the open label phase of the study.
General disorders Nightmares	13.3% 2/15 • Number of events 2 • Adverse events also assessed post quitting smoking during the open label phase of the study.	6.7% 1/15 • Number of events 1 • Adverse events also assessed post quitting smoking during the open label phase of the study.
Respiratory, thoracic and mediastinal disorders Nose Mucus	20.0% 3/15 • Number of events 3 • Adverse events also assessed post quitting smoking during the open label phase of the study.	46.7% 7/15 • Number of events 7 • Adverse events also assessed post quitting smoking during the open label phase of the study.
Skin and subcutaneous tissue disorders Rash	13.3% 2/15 • Number of events 2 • Adverse events also assessed post quitting smoking during the open label phase of the study.	20.0% 3/15 • Number of events 3 • Adverse events also assessed post quitting smoking during the open label phase of the study.
General disorders Sleepiness	40.0% 6/15 • Number of events 6 • Adverse events also assessed post quitting smoking during the open label phase of the study.	20.0% 3/15 • Number of events 3 • Adverse events also assessed post quitting smoking during the open label phase of the study.
Endocrine disorders Sweating	26.7% 4/15 • Number of events 4 • Adverse events also assessed post quitting smoking during the open label phase of the study.	46.7% 7/15 • Number of events 7 • Adverse events also assessed post quitting smoking during the open label phase of the study.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Problem	33.3% 5/15 • Number of events 5 • Adverse events also assessed post quitting smoking during the open label phase of the study.	13.3% 2/15 • Number of events 2 • Adverse events also assessed post quitting smoking during the open label phase of the study.
General disorders Vivid Dreams	66.7% 10/15 • Number of events 10 • Adverse events also assessed post quitting smoking during the open label phase of the study.	80.0% 12/15 • Number of events 12 • Adverse events also assessed post quitting smoking during the open label phase of the study.
Gastrointestinal disorders Vomiting	13.3% 2/15 • Number of events 2 • Adverse events also assessed post quitting smoking during the open label phase of the study.	0.00% 0/15 • Adverse events also assessed post quitting smoking during the open label phase of the study.
General disorders Other	20.0% 3/15 • Number of events 3 • Adverse events also assessed post quitting smoking during the open label phase of the study.	33.3% 5/15 • Number of events 5 • Adverse events also assessed post quitting smoking during the open label phase of the study.