Novel Treatments to Enhance Smoking Cessation Before Cancer Surgery: Effects on Smoking and Surgical Outcomes

NCT01479998 | Terminated Phase 1 DMC

• 2 other identifiers: 1104008332P50DA009241
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

Eligible participants will be randomized to either: 1) standard care (i.e., 4 counseling sessions and nicotine replacement therapy (NRT)) or 2) standard care + contingency management (i.e., 4 counseling sessions and NRT + 3x/week meetings with positive reinforcers)

Conditions

Smoking Cessation

Keywords

smoking cessation; NRT nicotine replacement therapy; CBT cognitive behavioral therapy; contingency management

Outcome Measures

Primary Outcomes (1)

• smoking cessation

  up to 3 months

Study Arms (2)

Standard care and nicotine replacement therapy

ACTIVE COMPARATOR

standard care is 4 counseling sessions and nicotine replacement therapy

Other: standard care

standard care plus NRT plus contingency management

EXPERIMENTAL

standard care is 4 counseling sessions and nicotine replacement therapy plus 3 weekly meetings with positive reinforcers

Other: standard care plus contingency management

Interventions

standard care OTHER

standard care plus nicotine replacement therapy

Standard care and nicotine replacement therapy

standard care plus contingency management OTHER

standard care is 4 counseling sessions and nicotine replacement therapy plus 3 weekly meetings with positive reinforcers

standard care plus NRT plus contingency management

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older,
• smoking 5 or more cigarettes per day, and
• diagnosed with any type of head, neck, or thoracic cancer,
• agreement on a 3-week pre-surgical tobacco intervention by both patient and surgeon.

You may not qualify if:

• Unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia,
• history of allergic reactions to adhesives,
• females of childbearing potential who are pregnant, nursing, or not practicing effective contraception.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06615, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Benjamin Toll, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2011
• First Posted: November 28, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 9, 2020

Record last verified: 2020-03

Locations

US (2)