Effects of Varenicline in Heavy Drinking Smokers

• Status: Withdrawn
• Trial end date: 2016-07-17
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Treatments: Ethanol; Varenicline

Criteria

Inclusion Criteria:

1. Be between the ages of 21 and 55 and provide informed consent;

2. Smoke > 10 cigarettes per day for > 2 years and have a carbon monoxide (CO) > 10 ppm;

3. Report an interest in quitting smoking in the near future, but currently not in the process of quitting;

4. 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;

5. Not seeking or receiving treatment for alcohol use;

6. 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);

7. Negative urine toxicology screen for narcotics, amphetamines, and sedative hypnotics at screening;

8. No lifetime history of psychotic disorders, bipolar disorders, or major depression with suicidal ideation;

9. No current symptoms of moderate depression or higher, indexed by a score ≥ 20 on the Beck Depression Inventory-II (BDI);

10. No serious alcohol withdrawal symptoms as indicated by a score < 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised;

11. Not pregnant, nursing, or planning on becoming pregnant in the next month (if female);

12. Have no medical condition that may interfere with safe study participation (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes);

13. Within normal limit aspartate transaminase (AST), alanine transaminase (ALT), or gamma-glutamyl transferase (GGT) levels;

14. Not currently on prescription medication that contraindicates use of VAR.