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Trial record 15 of 22 for:    counseling | Recruiting, Not yet recruiting, Available Studies | "Tobacco Use Disorder"

New Approaches to Smoking Cessation in Heavy Drinkers

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ClinicalTrials.gov Identifier: NCT02151591
Recruitment Status : Recruiting
First Posted : May 30, 2014
Last Update Posted : December 23, 2016
Sponsor:
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Cigarette Smoking Alcohol Consumption Heavy Drinking Drug: Varenicline Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: New Approaches to Smoking Cessation in Heavy Drinkers
Study Start Date : May 2014
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CBT for SA
Cognitive-behavioral therapy for smoking and alcohol (CBT for SA) entails weekly counseling for 12-weeks. Sessions are focused on providing personalized, health feedback to motivate participants to make changes in smoking and drinking and teaching skills that will help them sustain changes in both behaviors. Skills target heavy drinking smokers' social environments and negative affect (i.e., anger, stress, anxiety, boredom). Participants in this condition will also receive 12 weeks of varenicline (Chantix).
Drug: 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

Other Name: Chantix

Standard Smoking Counseling (SC)
Smoking counseling alone (SC) entails weekly counseling for 12-weeks. Sessions are focused on developing and implementing a smoking quit plan. Participants in this condition will also receive 12 weeks of varenicline (Chantix).
Drug: 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

Other Name: Chantix




Primary Outcome Measures :
  1. Evaluate feasibility and acceptability of cognitive-behavioral therapy (CBT) for smoking and alcohol (SA) [ Time Frame: 12 weeks ]
    Participants will complete a questionnaire after each session to indicate: (1) the helpfulness of the session content, (2) the importance/value of the session content, (3) how easy it was to understand the session content, and (4) how likely they are to change their smoking/drinking after learning the session content.


Secondary Outcome Measures :
  1. Smoking Abstinence [ Time Frame: 24 Weeks ]
    The primary smoking outcome will be point prevalence smoking abstinence (i.e., no smoking,not even a puff over the last 7 days) at the 24 week follow-up assessment after treatment completion.

  2. Reductions in drinking [ Time Frame: 24 weeks ]
    The primary drinking outcome will be the change in the number of heavy drinking days from the week before quitting smoking to the 24 week follow-up assessment after treatment completion.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02151591


Contacts
Contact: Lisa Fucito, PhD 203-974-5759 lisa.fucito@yale.edu

Locations
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Lisa Fucito, PhD Yale University

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02151591     History of Changes
Other Study ID Numbers: K23AA020000-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 2016

Keywords provided by Yale University:
Quit smoking
Quit drinking

Additional relevant MeSH terms:
Tobacco Use Disorder
Alcohol Drinking
Alcoholic Intoxication
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Drinking Behavior
Alcohol-Related Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs