Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation
| Status: | Recruiting |
|---|---|
| Conditions: | Smoking Cessation, Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 5/4/2018 |
| Start Date: | March 29, 2018 |
| End Date: | November 2019 |
| Contact: | Patrick McNamara, B.S |
| Email: | pmcnamar@bsdad.uchicago.edu |
| Phone: | 7737025047 |
The purpose of this study is to learn if the combination of a study drug and patch is more
effective in helping heavy drinkers stop smoking than just the patch alone The study drug,
varenicline, has been approved by the Food and Drug Administration (FDA) to help people stop
smoking, but it is not known if the addition of varenicline to standard smoking cessation
treatment with nicotine patches will help people stop smoking who are regular, frequent
drinkers. This study is being done because cigarette smoking is the number one preventable
cause of death and disease in the United States.
effective in helping heavy drinkers stop smoking than just the patch alone The study drug,
varenicline, has been approved by the Food and Drug Administration (FDA) to help people stop
smoking, but it is not known if the addition of varenicline to standard smoking cessation
treatment with nicotine patches will help people stop smoking who are regular, frequent
drinkers. This study is being done because cigarette smoking is the number one preventable
cause of death and disease in the United States.
This study will conduct a real-world clinic-based smoking cessation trial examining the
augmentation strategy of Chantix (Varenicline Tartrate), nicotine patch, and behavioral
counseling versus standard treatment of patch plus behavioral counseling only in heavy
drinkers who smoke (HDS). While Chantix is approved for smoking cessation, it is not
routinely given in practice for HDS patients
In this study, there will be 4 total in-person study visits over the trial (pre-quit, quit
date, week 2 and week 12), ending 12 weeks after the quit date. Biochemical verification from
breath tests for CO, as well as vital signs and weight, will be measured at each visit along
with survey responses measuring smoking urge and withdrawal, negative affect, neurocognition,
and alcohol and smoking behaviors. These will also be used at a 26-week follow-up by
telephone with biochemical verification for CO in those reporting being smoke-free.
Screening and Randomization Participants will respond to advertisements and will undergo a
brief phone screening to determine initial eligibility requirements. Qualified candidates
will be invited into the lab to conduct a short screening and study information session at
the Clinical Addictions Research Laboratory at the University of Chicago. At screening,
participants will sign an informed consent document. Next, demographics, smoking, alcohol and
substance use patterns, health history, medications, vital signs, a urine test (for pregnancy
and/or drug toxicology) and a blood test will be obtained.
Eligible participants will be randomized into one of two treatment groups: Standard Treatment
will proceed with the study receiving nicotine patches and brief counseling sessions;
Augmented Treatment will proceed with the same nicotine patches and brief counseling
sessions, but will also receive standard dosing of Chantix (Varenicline tartrate).
Nicotine Patches Nicotine patches will be utilized starting at study quit date, and proceed
according to package insert directions (10+ cigs/day smokers will begin with 21mg patches for
six weeks, followed by 14mg patches for four weeks, and finally 7mg patches for two weeks.
Those smoking fewer than 10 cigarettes/day will follow the same process starting at the 14mg
patch level.
Chantix (Varenicline Tartrate) Those receiving Augmented Treatment will receive varenicline
in this effectiveness study. They will undergo an up-titration week prior to the quit date,
12 weeks of target dosing, and a down-titration week. As per Pfizer recommendations,
up-titration will be 0.5mg tablets once daily for 3 days followed by twice daily for four
days leading to the quit date on day 8. The sequence will reverse for a down-titration week
on week 13.
Smoking Cessation Behavioral Sessions:
Participants will attend one-on-one behavioral counseling sessions with a trained Masters or
PhD. Level therapist at each study visit. Behavioral sessions will involve teaching
behavioral skills to assist with smoking cessation, preventing relapse, and coping with
physical or emotional changes associated with cravings. At each study visit, subjective
measures (i.e. brief self-report surveys about
Follow-Up Interview (Week 26) At Study Week 26, participants will complete a follow-up
telephone interview, completing similar subjective measures as those completed during study
visits. Participants reporting being smoke-free during this interview will arrange for
biochemical verification of this status via expired CO testing either by arranging for a time
to stop into one of the study sites or by arranging for study staff to meet with them in
their home or workplace.
augmentation strategy of Chantix (Varenicline Tartrate), nicotine patch, and behavioral
counseling versus standard treatment of patch plus behavioral counseling only in heavy
drinkers who smoke (HDS). While Chantix is approved for smoking cessation, it is not
routinely given in practice for HDS patients
In this study, there will be 4 total in-person study visits over the trial (pre-quit, quit
date, week 2 and week 12), ending 12 weeks after the quit date. Biochemical verification from
breath tests for CO, as well as vital signs and weight, will be measured at each visit along
with survey responses measuring smoking urge and withdrawal, negative affect, neurocognition,
and alcohol and smoking behaviors. These will also be used at a 26-week follow-up by
telephone with biochemical verification for CO in those reporting being smoke-free.
Screening and Randomization Participants will respond to advertisements and will undergo a
brief phone screening to determine initial eligibility requirements. Qualified candidates
will be invited into the lab to conduct a short screening and study information session at
the Clinical Addictions Research Laboratory at the University of Chicago. At screening,
participants will sign an informed consent document. Next, demographics, smoking, alcohol and
substance use patterns, health history, medications, vital signs, a urine test (for pregnancy
and/or drug toxicology) and a blood test will be obtained.
Eligible participants will be randomized into one of two treatment groups: Standard Treatment
will proceed with the study receiving nicotine patches and brief counseling sessions;
Augmented Treatment will proceed with the same nicotine patches and brief counseling
sessions, but will also receive standard dosing of Chantix (Varenicline tartrate).
Nicotine Patches Nicotine patches will be utilized starting at study quit date, and proceed
according to package insert directions (10+ cigs/day smokers will begin with 21mg patches for
six weeks, followed by 14mg patches for four weeks, and finally 7mg patches for two weeks.
Those smoking fewer than 10 cigarettes/day will follow the same process starting at the 14mg
patch level.
Chantix (Varenicline Tartrate) Those receiving Augmented Treatment will receive varenicline
in this effectiveness study. They will undergo an up-titration week prior to the quit date,
12 weeks of target dosing, and a down-titration week. As per Pfizer recommendations,
up-titration will be 0.5mg tablets once daily for 3 days followed by twice daily for four
days leading to the quit date on day 8. The sequence will reverse for a down-titration week
on week 13.
Smoking Cessation Behavioral Sessions:
Participants will attend one-on-one behavioral counseling sessions with a trained Masters or
PhD. Level therapist at each study visit. Behavioral sessions will involve teaching
behavioral skills to assist with smoking cessation, preventing relapse, and coping with
physical or emotional changes associated with cravings. At each study visit, subjective
measures (i.e. brief self-report surveys about
Follow-Up Interview (Week 26) At Study Week 26, participants will complete a follow-up
telephone interview, completing similar subjective measures as those completed during study
visits. Participants reporting being smoke-free during this interview will arrange for
biochemical verification of this status via expired CO testing either by arranging for a time
to stop into one of the study sites or by arranging for study staff to meet with them in
their home or workplace.
Inclusion Criteria:
- Smoke 3-30 cigarettes/day
- Desire to quit smoking as indicated on a smoking stages ladder
- Consume >14 (men) or >7 (women) standard alcohol drinks per week (e.g., 1 drink = 12
oz beer, 5 oz wine, 1.5 oz liquor)
- Ability to understand, read, and write in English, at least 8th grade education
- Willing and able to sign an informed consent
- Stable residence and contact information.
Exclusion Criteria:
- Hepatic panel indices > 2 SD
- History of seizures or DTs during alcohol withdrawal
- Unstable medical (e.g., hepatitis, cirrhosis, seizure disorder, recent major
cardiovascular event, etc.) or psychiatric disorder (e.g., active hallucinations,
severe depression, obsessional thinking, self-injury risking significant blood loss,
etc.) deemed by the study physician to be at significant risk for adverse interactions
with study medications or measures.
- History of adverse reactions to varenicline (VAR) or nicotine patch
- Current suicidal ideation (past 6 months) and/or history of major suicide attempts.
- For women of child-bearing potential: currently pregnant, lactating, current plans to
become pregnant in next three months, or unable to agree to adequate birth control
during study participation.
We found this trial at
1
site
Chicago, Illinois 60637
Principal Investigator: Andrea C King, PhD
Phone: 773-702-5047
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