Varenicline for Smoking Cessation in Heavy Drinking Smokers

NCT00860028 | Completed Phase 2 Results DMC

• 2 other identifiers: NIAAA-O'Malley-P50AA15632-2009P50AA015632
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether extended pretreatment with varenicline (Chantix) is more efficacious for smoking cessation than standard pretreatment, how well varenicline is tolerated in heavy drinking smokers, and whether varenicline reduces alcohol consumption.

Conditions

Nicotine Dependence; Smoking; Heavy Drinking

Keywords

Smoking cessation; Smoking; Tobacco; Varenicline; Alcohol

Outcome Measures

Primary Outcomes (2)

• Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions.

  Compares the number of participants who reported no smoking, not even a puff, from the quit date through until the end of treatment (i.e., last 4 weeks of treatment) in the varenicline versus placebo pretreatment conditions.

  Last 4 weeks of treatment

• Mean Percentage of Heavy Drinking Days Comparing Participants in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions

  Compares the mean percentage of heavy drinking days over the 3-week placebo-controlled pretreatment phase comparing participants in the extended varenicline pretreatment versus the short-term varenicline pretreatment conditions. Heavy drinking defined as consuming 4 or more drinks per occasion for women and 5 or more drinks per occasion for men. Drinking in the final week of pretreatment prior to the quit-date is not included because both groups were receiving active varenicline during this period.

  First 3 weeks (pretreatment)

Secondary Outcomes (1)

• Number of Participants Who Reported an Adverse Event in the Varenicline Pretreatment Versus Placebo Pretreatment Conditions

  First 3 weeks (pretreatment)

Study Arms (2)

Extended Varenicline Pretreatment

EXPERIMENTAL

Arm 1 (Experimental) = 4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day before the smoking quit date followed by 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment.

Drug: Extended Varenicline Pretreatment

Short-term Varenicline Pretreatment

EXPERIMENTAL

Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date.

Drug: Short-term Varenicline Pretreatment

Interventions

Extended Varenicline Pretreatment DRUG

4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day before the smoking quit date followed by 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment.

Also known as: chantix

Extended Varenicline Pretreatment

Short-term Varenicline Pretreatment DRUG

3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date.

Also known as: Placebo

Short-term Varenicline Pretreatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18 and 75.
• Smoking 5 or more cigarettes per occasion at least 3 times per week.
• Fewer than 3 months of smoking abstinence in the past year.
• Motivated to stop smoking.
• Report exceeding maximum weekly drinking limits every week in the past 4 weeks and exceeding maximum daily drinking limits on at least 1 occasion in the past 4 weeks. Weekly heavy drinking is defined as 8 or more drinks for women and 15 or more drinks for men. Daily heavy drinking is defined as 4 or more drinks for women and 5 or more drinks for men on an occasion.

You may not qualify if:

• Exhibit current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation
• Any unexplained elevations in liver enzymes (i.e., transaminases, bilirubin)
• Clinically significant cardiovascular disease
• Uncontrolled hypertension
• Hepatic or renal impairment
• Severe chronic obstructive pulmonary disease
• Diabetes mellitus requiring insulin or oral hypoglycemic medications.
• Baseline systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 95 mm Hg
• History of cancer (except treated basal cell or squamous cell carcinoma of the skin).
• History of clinically significant allergic reactions.
• Exhibit serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe major depression, panic disorder, borderline personality disorder, organic mood or mental disorders, or substantial suicide or violence risk) by history or psychological examination)
• Have a current diagnosis of DSM-IV drug dependence other than nicotine or alcohol.
• Have a current Diagnostic and Statistical Manual Diploma in Social Medicine IV (DSM-IV) diagnosis of alcohol dependence that is clinically severe defined by a) a history of seizures, delirium, or hallucinations during alcohol withdrawal, b) a Clinical Institute Withdrawal Assessment scale (Sullivan et al., 1989) score of \> 8, c) report drinking to avoid withdrawal symptoms, or d) have had prior treatment of withdrawal.
• Use of another investigational drug within 30 days.
• Intention to donate blood or blood products during the treatment phase of the study.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Related Publications (2)

• Fucito LM, Toll BA, Wu R, Romano DM, Tek E, O'Malley SS. A preliminary investigation of varenicline for heavy drinking smokers. Psychopharmacology (Berl). 2011 Jun;215(4):655-63. doi: 10.1007/s00213-010-2160-9. Epub 2011 Jan 11.

  PMID: 21221531 RESULT

• Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

  PMID: 37142273 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking; Smoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Dr. Stephanie O'Malley
• Organization: Yale School of Medicine

stephanie.omalley@yale.edu

203-974-7590

Study Officials

• Stephanie S O'Malley, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2009
• First Posted: March 11, 2009
• Study Start: October 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 13, 2021
• Results First Posted: March 7, 2013

Record last verified: 2021-08