Alcohol Consumption, Cigarette Smoking, Heavy Drinking, Nicotine Dependence
Conditions
Keywords
Quit smoking, Quit drinking
Brief summary
The purpose of this study is to develop and test an integrated cognitive-behavioral intervention for smoking and alcohol among heavy drinking smokers. The current pre-pilot phase will be used to refine this protocol for the subsequent randomized, controlled pilot phase. The current study phase has two parts: 1) an intake session and brief physical; 2) a 12-week treatment phase in which participants receive varenicline (Chantix) and weekly, personalized counseling.
Detailed description
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.
Interventions
DRUGVarenicline
12-weeks of treatment. Dose will be titrated as follows: Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Smoking Abstinence at 6 Months | 6 months post treatment start | Number of participants with point prevalence smoking abstinence (i.e., no smoking, not even a puff over the last 7 days) 6 months after treatment completion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Log Transformed Percentage of Heavy Drinking Days | 6 months post treatment start | Log transformed percentage of heavy drinking days 6 months post treatment start. |
| Number of Participants Who Completed Treatment. | 12 weeks | To assess feasibility/acceptability, the number of participants who completed treatment will be assessed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Integrated Counseling for Tobacco and Alcohol (INT) Integrated counseling for smoking and alcohol entails weekly counseling for 12-weeks targeting both behaviors. Participants in this condition will also receive 12 weeks of varenicline (Chantix).
Varenicline: 12-weeks of treatment. Dose will be titrated as follows:
Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day | 13 |
| Standard Care for Primary Presenting Concern (SC) Standard care (SC) for primary presenting concern only. For those presenting with the primary concern of tobacco, standard care will involve weekly smoking counseling alone for 12-weeks. For those presenting with the primary concern of alcohol, standard care will involve weekly alcohol counseling alone. Participants in this condition will also receive 12 weeks of varenicline (Chantix).
Varenicline: 12-weeks of treatment. Dose will be titrated as follows:
Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day | 13 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 3 |
Baseline characteristics
| Characteristic | Integrated Counseling for Tobacco and Alcohol (INT) | Standard Care for Primary Presenting Concern (SC) | Total |
|---|---|---|---|
| Age, Continuous | 39.00 age STANDARD_DEVIATION 10.59 | 42.62 age STANDARD_DEVIATION 13.23 | 40.81 age STANDARD_DEVIATION 11.87 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 11 Participants | 10 Participants | 21 Participants |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
Primary
Number of Participants With Smoking Abstinence at 6 Months
Number of participants with point prevalence smoking abstinence (i.e., no smoking, not even a puff over the last 7 days) 6 months after treatment completion.
Time frame: 6 months post treatment start
Population: Number of participants with smoking abstinence at 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Integrated Counseling for Tobacco and Alcohol (INT) | Number of Participants With Smoking Abstinence at 6 Months | 6 Participants |
| Standard Care for Primary Presenting Concern (SC) | Number of Participants With Smoking Abstinence at 6 Months | 3 Participants |
Secondary
Log Transformed Percentage of Heavy Drinking Days
Log transformed percentage of heavy drinking days 6 months post treatment start.
Time frame: 6 months post treatment start
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integrated Counseling for Tobacco and Alcohol (INT) | Log Transformed Percentage of Heavy Drinking Days | 2.06 Mean log transformed percentage score | Standard Error 0.4 |
| Standard Care for Primary Presenting Concern (SC) | Log Transformed Percentage of Heavy Drinking Days | 1.45 Mean log transformed percentage score | Standard Error 0.38 |
Secondary
Number of Participants Who Completed Treatment.
To assess feasibility/acceptability, the number of participants who completed treatment will be assessed.
Time frame: 12 weeks
Population: Number of participants who completed treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Integrated Counseling for Tobacco and Alcohol (INT) | Number of Participants Who Completed Treatment. | 7 Participants |
| Standard Care for Primary Presenting Concern (SC) | Number of Participants Who Completed Treatment. | 10 Participants |