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 range21 Years – 55 Years

SexALL

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

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 range21 Years – 55 Years

SexALL

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