Extended Varenicline Treatment for Smoking Among Cancer Patients

NCT01756885 | Completed Phase 3 Results DMC

• 1 other identifier: R01CA165001
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 2

Brief Summary

Upwards of 33-50% of cancer patients who smoked prior to diagnosis continue to smoke following diagnosis and treatment. With medical advances in cancer care yielding a growing constituency of cancer survivors, addressing nicotine dependence in this population is a priority. While PHS guidelines recommend acute treatment durations with approved medications for tobacco use, extending the duration of treatment beyond the standard treatment duration significantly increases quit rates, reduces the risk for a relapse, and promotes recovery to abstinence following a lapse. Varenicline may be particularly effective for cancer patients given the drug's beneficial effects on affect and cognition. In this trial, 374 cancer patients will be randomized to standard varenicline treatment (12 weeks active + 12 weeks placebo) or extended varenicline treatment (24 weeks active). The investigators hypothesize that 1) Extended varenicline therapy will increase 24- and 52-week biochemically-confirmed abstinence versus standard varenicline treatment, 2) Quality of life will be rated higher in the extended therapy group versus the standard therapy group, and there will be no significant differences between groups in terms of severe side effects, and 3) Improved affect and reduced cognitive impairment will mediate the effect of extended therapy on quit rates.

Conditions

Nicotine Dependence

Keywords

Smoking cessation; Nicotine dependence; Varenicline; Chantix; Cancer

Outcome Measures

Primary Outcomes (1)

• 7-day CO-verified Tobacco Abstinence

  Number of Participants with Verified 7 Day Tobacco Abstinence.

  Weeks 24 & 52

Secondary Outcomes (1)

• Quality of Life at Week 24 and 52

  Weeks 24 & 52

Other Outcomes (1)

• Number of Participants With Continuous Abstinence

  Weeks 12, 24, and 52

Study Arms (2)

Standard Varenicline Treatment

ACTIVE COMPARATOR

12 weeks of active varenicline + 12 weeks of placebo + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally Days 85-168: Placebo - 1.0mg twice daily orally

Drug: Varenicline; Drug: Placebo; Behavioral: Smoking Cessation Counseling

Extended Varenicline Treatment

EXPERIMENTAL

24 weeks of active varenicline + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-168: 1.0mg twice daily orally

Drug: Varenicline; Behavioral: Smoking Cessation Counseling

Interventions

Varenicline DRUG

Varenicline was used in accordance with FDA approved labeling: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).

Also known as: Chantix

Extended Varenicline Treatment; Standard Varenicline Treatment

Placebo DRUG

On Day 85, participants randomized to standard therapy will be given placebo pills (resembling the 1.0mg pills),

Standard Varenicline Treatment

Smoking Cessation Counseling BEHAVIORAL

Behavioral Counseling (from Week 0 - Week 18) The counseling protocol was based on PHS guidelines for smoking cessation treatment (Fiore et al., 2008), used in our past studies with cancer patients (Schnoll et al., 2010a) and in our ongoing cessation trial at NU (R01 DA025078). Counseling is included given its efficacy at helping smokers quit (Fiore et al., 2008) and to increase study retention. Counseling is provided to both treatment arms through Week 18 to equate for time and attention across arms and since this method was used in varenicline clinical trials (Gonzales et al., 2006) and in our extended therapy trial (Schnoll et al., 2010b). In-person counseling was selected for most sessions to ensure adequate monitoring of participant safety and adherence throughout the trial.

Extended Varenicline Treatment; Standard Varenicline Treatment

Eligibility Criteria

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

You may qualify if:

• years of age or older who self-report smoking at least 5 cigarettes (menthol and non-menthol) per day, on average, for the last 6 months.
• Current cancer diagnosis (all sites) or diagnosis within the past 5 years.
• Karnofsky Score of \>50 or ECOG Performance Status score of \<2 within 6 months of enrollment.
• Able to use varenicline safely, based on a medical evaluation including medical history and physical examination, and psychiatric evaluation.
• Residing in the geographic area for at least 12 months.
• Women of childbearing potential (based on medical history and physical exam) must consent to use a medically accepted method of birth control (e.g., condoms and spermicide, oral contraceptive, Depo-Provera injection, contraceptive patch, tubal ligation) or abstain from sexual intercourse during the time they are taking study medication and for at least one month after the medication period ends.
• Able to communicate fluently in English.
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent/HIPAA form.

You may not qualify if:

• Smoking Behavior
• Current enrollment or plans to enroll in another smoking cessation program in the next 12 months.
• Regular (daily) use of chewing tobacco, snuff, snus, cigars, cigarillos, or pipes.
• Current use or plans to use nicotine substitutes (gum, patch, lozenge, e-cigarette) or smoking cessation treatments in the next 12 months.
• Note: Once participants are found eligible for the study, they are told they should refrain from using any nicotine replacement therapy (NRT) for the duration of the study. If a subject reports an isolated (non-daily) instance of NRT use during the study, they may be permitted to continue.
• Diagnosis of substance abuse or dependence that has been unstable in the past year.
• Positive urine drug screen (for cocaine, opioids, or methamphetamines) at the Intake Session (unless taking opiate for pain management).
• Breath Alcohol Concentration (BrAC) assessment greater than or equal to 0.01 at the Intake Session.
• Current alcohol consumption that exceeds 25 standard alcoholic drinks/week.
• Current use or recent discontinuation (within last 14 days) of the following medications:
• Other smoking cessation medications (e.g. Zyban, Wellbutrin, Wellbutrin SR, Chantix)
• a. Note: Once participants are found eligible for the study, they are instructed to only use the smoking cessation medication provided to them by the study staff. If a subject reports an isolated (non-daily) instance of using a non-study smoking cessation medication, the study physician and PI will evaluate the situation and determine if it is safe for the subject to continue participation.
• Anti-psychotic medications.
• Bipolar Disorder medications.
• Women who are pregnant, planning a pregnancy within the next 12 months, or lactating.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation; Neoplasms

Interventions

Varenicline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Robert Schnoll
• Organization: University of Pennsylvania

schnoll@pennmedicine.upenn.edu

215-746-7143

Study Officials

• Robert A Schnoll, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: December 28, 2012
• Study Start: January 1, 2013
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: July 30, 2019
• Results First Posted: June 4, 2019

Record last verified: 2019-07

Locations

US (2)