WithdrawnPhase 4

Effects of Varenicline in Heavy Drinking Smokers

Stopped: Investigator left institution prior to enrollment of study participants

United States0Started 2015-08

Plain-language summary

This laboratory study will examine if varenicline can reduce alcohol-induced smoking lapse in heavy drinking smokers.

Who can participate

Age range

21 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Be between the ages of 21 and 55 and provide informed consent;
. Smoke \> 10 cigarettes per day for \> 2 years and have a carbon monoxide (CO) \> 10 ppm;
. Report an interest in quitting smoking in the near future, but currently not in the process of quitting;
. Report current heavy drinking according to NIAAA guidelines (62): for men, \> 14 drinks per week or ≥ 5 drinks per occasion at least once per month over the past 12 months; for women, \> 7 drinks per week or ≥ 4 drinks per occasion at least once per month over the past 12 months;
. Not seeking or receiving treatment for alcohol use;
. No current (last 12 months) diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V);
. Negative urine toxicology screen for narcotics, amphetamines, and sedative hypnotics at screening;
. No lifetime history of psychotic disorders, bipolar disorders, or major depression with suicidal ideation;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The latency to initiate smoking during the delay period. Performance on the smoking lapse task

Timeframe: The task will begin five minutes after consumption of the alcohol or placebo beverage and last between 60 and 120 minutes based on performance

The number of cigarettes smoked during the self-administration period. Performance on the smoking lapse task

Timeframe: The task will begin five minutes after consumption of the alcohol or placebo beverage and last between 60 and 120 minutes based on performance

Trial details

NCT IDNCT02488889

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-07-17

View on ClinicalTrials.gov More Cigarette Smoking trials

Who can participate

Age range

21 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Be between the ages of 21 and 55 and provide informed consent;
. Smoke \> 10 cigarettes per day for \> 2 years and have a carbon monoxide (CO) \> 10 ppm;
. Report an interest in quitting smoking in the near future, but currently not in the process of quitting;
. Report current heavy drinking according to NIAAA guidelines (62): for men, \> 14 drinks per week or ≥ 5 drinks per occasion at least once per month over the past 12 months; for women, \> 7 drinks per week or ≥ 4 drinks per occasion at least once per month over the past 12 months;
. Not seeking or receiving treatment for alcohol use;
. No current (last 12 months) diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V);
. Negative urine toxicology screen for narcotics, amphetamines, and sedative hypnotics at screening;
. No lifetime history of psychotic disorders, bipolar disorders, or major depression with suicidal ideation;

What they're measuring

The latency to initiate smoking during the delay period. Performance on the smoking lapse task

Timeframe: The task will begin five minutes after consumption of the alcohol or placebo beverage and last between 60 and 120 minutes based on performance

The number of cigarettes smoked during the self-administration period. Performance on the smoking lapse task

Timeframe: The task will begin five minutes after consumption of the alcohol or placebo beverage and last between 60 and 120 minutes based on performance