Trial Outcomes & Findings for Varenicline For Smokers In Recovery From Alcohol Dependence (NCT NCT01092702)

NCT ID: NCT01092702

Last Updated: 2023-09-25

Results Overview

The primary endpoint of this trial is biochemically confirmed 7-day point prevalence smoking abstinence at the end of the medication phase (week 12). Self-reported abstinence from smoking (not even a puff) over the last 7-days will be considered biochemically confirmed by an expired air CO of \<8 ppm. Subjects who discontinue the study or have a missed visit for any reason will be classified as smoking for that visit.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 32 participants
• Primary outcome timeframe: 12 weeks from start of medication
• Results posted on: 2023-09-25

Participant Flow

Recruitment began on 04/14/2008 and finished on 08/28/2008. Recruitment was in the general community of Rochester, Minnesota

All potential participants consenting to enrollment completed a series of screening questionnaires. The questionnaires included demographic information, alcohol and smoking history, the the Center for Epidemiological Studies-Depressed Mood Scale, DAST-20, medical history and physical exam.

Participant milestones

Measure	Varenicline Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
Overall Study STARTED	32
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	Varenicline Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
Overall Study Withdrawal by Subject	7
Overall Study Lost to Follow-up	2

Baseline Characteristics

Varenicline For Smokers In Recovery From Alcohol Dependence

Baseline characteristics by cohort

Measure	Varenicline n=32 Participants Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	42.9 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants
cigarettes per day	20.3 cigarettes per day STANDARD_DEVIATION 5.0 • n=5 Participants
Duration of alcohol recovery	29 months n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks from start of medication

The primary endpoint of this trial is biochemically confirmed 7-day point prevalence smoking abstinence at the end of the medication phase (week 12). Self-reported abstinence from smoking (not even a puff) over the last 7-days will be considered biochemically confirmed by an expired air CO of <8 ppm. Subjects who discontinue the study or have a missed visit for any reason will be classified as smoking for that visit.

Outcome measures

Measure	Varenicline n=32 Participants Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
Biochemically Confirmed Abstinence From Smoking	10 participants

Adverse Events

Varenicline

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 n=32 participants at risk Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
Gastrointestinal disorders Nausea	28.1% 9/32 • Adverse Events were collected for the 12 weeks of study medication phase.
General disorders Sleep Disturbance	18.8% 6/32 • Adverse Events were collected for the 12 weeks of study medication phase.
General disorders Abnormal Dreams	15.6% 5/32 • Adverse Events were collected for the 12 weeks of study medication phase.
Psychiatric disorders Depression/Anxiety	15.6% 5/32 • Adverse Events were collected for the 12 weeks of study medication phase.
Gastrointestinal disorders other gastrointestinal	9.4% 3/32 • Adverse Events were collected for the 12 weeks of study medication phase.
Psychiatric disorders behavior Change	6.2% 2/32 • Adverse Events were collected for the 12 weeks of study medication phase.
General disorders Headache	6.2% 2/32 • Adverse Events were collected for the 12 weeks of study medication phase.

Additional Information

J Taylor Hays. MD

Mayo Clinic

Phone: 507-266-1944

Email: nicotineresearch@mayo.edu

Results disclosure agreements

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