New Approaches to Smoking Cessation in Heavy Drinkers

The purpose of the proposed project is to develop and test a 12-week integrated
cognitive-behavioral therapy (CBT) intervention for smoking and alcohol (SA) + varenicline
(Chantix) among heavy drinking smokers (i.e., CBT for SA). The project involves two phases.
In Phase 1, an open-label pre-pilot study of CBT for SA will be conducted with 10 heavy
drinking smokers. The primary results of this phase will be used to refine the CBT for SA
protocol. In Phase 2, a randomized, controlled pilot study will be conducted with 40 heavy
drinking smokers comparing CBT for SA with standard smoking counseling (SC). All
participants in the randomized pilot study will also receive varenicline (Chantix).

Primary and Study Completion dates were changed 6/2016 to reflect an additional year added
year to the study.

Inclusion Criteria:

1. are at least 18 years of age;

2. report smoking 100 cigarettes over lifetime and currently smoke at least twice weekly
on average in the past 90 days and have a urinary cotinine level of >=30ng/mL by
semi-quantitative analysis, and/or >= 2 on a NicAlert dipstick

3. are interested in quitting smoking;

4. understand English;

5. exceed National Institute on Alcohol Abuse and Alcoholism heavy drinking criteria
(i.e., for men, >14 drinks/week or 5 drinks/day at least once per month over the past
12 months; for women, >7 drinks/week or >4 drinks/day at least once per month over
the past 12 months.

Exclusion Criteria:

1. meet criteria for alcohol dependence in the past 12 months that is clinically severe
defined by

- a history of seizures, delirium, or hallucinations during alcohol withdrawal;

- a Clinical Institute Withdrawal Assessment scale (Sullivan et al., 1989) score
of > 8;

- report drinking to avoid withdrawal symptoms, or d) have had prior treatment of
withdrawal;

- have required medical treatment of alcohol withdrawal within the past 6 months;

2. are currently enrolled in alcohol treatment;

3. meet criteria for drug dependence in the past 12 months; with the exception of
marijuana dependence

4. exhibit serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe
major depression, panic disorder, borderline personality disorder, organic mood or
mental disorders by history or psychological examination;

5. report current suicidality (past 12 months), or report suicide attempts within the
past 10 years, assessed with the Columbia Suicide Severity Rating Scale;

6. exhibit current, clinically significant physical disease or abnormality based on
medical history, physical examination, or routine laboratory evaluation including:

- any unexplained elevations in liver enzymes (i.e., transaminases, bilirubin);

- clinically significant, unstable cardiovascular disease/uncontrolled
hypertension;

- hepatic or renal impairment;

- severe obstructive pulmonary disease;

- diabetes mellitus requiring insulin or certain oral medications (i.e.,
sulfonylureas) and an A1C hemoglobin test score of > 7 for participants not
prescribed these medications;

- baseline systolic blood pressure higher than 150 mm Hg or diastolic blood
pressure higher than 95 mm Hg;

7. are cognitively impaired;

8. are unable to read/understand English;

9. are a female of childbearing potential who is pregnant, nursing, or not practicing
effective contraception (oral, injectable, or implantable contraceptives,
intrauterine device, or barrier method with spermicide);

10. report new onset of psychiatric disorders or new psychotropic medications within the
past 3 months, except individuals who are on a stable dose of a Selective Serotonin
Reuptake Inhibitor for at least two months or who report occasional use of
prescription sleep aids that they are willing to discontinue;

11. have used another investigational drug within 30 days or have used medications to
treat alcohol (e.g., naltrexone, topiramate, acamprosate, disulfiram) or nicotine use
(e.g., clonidine, varenicline, bupropion, nicotine replacement) in the past 3 months
or intend to use these medications; (prior use of nicotine replacement in situations
where smoking is not permitted (e.g., planes) without the intention to quit smoking
is not exclusionary at screening)

12. intend to donate blood or blood products during the treatment phase of the study;

13. have a history of cancer (except treated basal cell or squamous cell carcinoma of the
skin);

14. have a history of serious hypersensitivity reactions or skin reactions to
varenicline.