Effects of Varenicline in Heavy Drinking Smokers

Withdrawn before enrolling · Phase 4 · Has a placebo group

Conditions studied: Cigarette Smoking, Alcohol Consumption

In brief

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

Key facts

Study ID

NCT02488889

Run by

University of California, Los Angeles

People needed

0

Starts

2015-08-01

Expected to finish

2016-07-17

Last updated by the study team

2018-06-01

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;
• No current symptoms of moderate depression or higher, indexed by a score ≥ 20 on the Beck Depression Inventory-II (BDI);
• No serious alcohol withdrawal symptoms as indicated by a score < 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised;
• Not pregnant, nursing, or planning on becoming pregnant in the next month (if female);
• Have no medical condition that may interfere with safe study participation (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes);
• Within normal limit aspartate transaminase (AST), alanine transaminase (ALT), or gamma-glutamyl transferase (GGT) levels;
• Not currently on prescription medication that contraindicates use of VAR.

Where it is running

• UCLA Addictions Laboratory — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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