Telephone Counseling and the Distribution of Nicotine Patches to Smokers

NCT00851357 | Completed Phase 3 Results

• 1 other identifier: CDPH 05-45834
• Study Type: interventional
• Target: 4,200
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to determine the effects of distributing free nicotine replacement therapy (NRT) to tobacco quitline callers directly. Specifically, this study aims to:

1. 1.Test if sending active nicotine patches directly will lead to a higher quit rate, compared to a condition where the quitline assists the smokers to obtain patches by other means (e.g. via their health plans).
2. 2.Test if sending placebo patches directly will also lead to a higher quit rate.
3. 3.Test if quitline counseling increases the quit rate when the smokers already receive the nicotine patches.

Conditions

Smoking Cessation

Keywords

Nicotine Replacement Therapy; Nicotine Patch; Smoking cessation; Telephone; Tobacco cessation; Counseling; Nicotine; Self-Help; Smoking abstinence; Tobacco Use Disorder

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Six-month Continuous Abstinence From Cigarettes

  7 months post enrollment

Secondary Outcomes (1)

• Number of Participants Quit for 30-days at 2-months Post Enrollment

  2-months post enrollment

Study Arms (6)

Active patches and telephone counseling

EXPERIMENTAL

Proactive Telephone Counseling and 8-weeks of nicotine patches

Drug: Nicotine Patch; Behavioral: Telephone Counseling

Placebo patches and telephone counseling

PLACEBO COMPARATOR

Proactive Telephone Counseling and 8-weeks of placebo patches

Behavioral: Telephone Counseling; Drug: Placebo

Telephone counseling

ACTIVE COMPARATOR

Proactive Telephone Counseling

Behavioral: Telephone Counseling

Active patches and materials

ACTIVE COMPARATOR

8-weeks of nicotine patches and materials

Drug: Nicotine Patch; Other: Self-Help Materials

Placebo patches and materials

ACTIVE COMPARATOR

8-weeks placebo patches and materials

Drug: Placebo; Other: Self-Help Materials

Materials

ACTIVE COMPARATOR

Self-help materials

Other: Self-Help Materials

Interventions

Nicotine Patch DRUG

Subjects are randomized into 1 of 3 conditions: active, placebo or usual care. Usual care subjects are not mailed patches; however, we facilitate their use by providing a certificate that can be used by the State Medicaid program and some insurance companies to obtain free patches. For those mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. Placebo patches will have no nicotine, but will be packaged to mimic the active patches.

Also known as: Habitrol

Active patches and materials; Active patches and telephone counseling

Telephone Counseling BEHAVIORAL

Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group. Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Telephone counseling includes a comprehensive pre-quit session (to include motivation, planning, and setting of a quit date and discussion of nicotine patch use) plus up to 5 proactive follow-up calls. Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling.

Active patches and telephone counseling; Placebo patches and telephone counseling; Telephone counseling

Placebo DRUG

Placebo nicotine patch

Also known as: Non-nicotine patch

Placebo patches and materials; Placebo patches and telephone counseling

Self-Help Materials OTHER

Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group. Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Reading materials and written consent will be mailed to all study subjects the next business day.

Active patches and materials; Materials; Placebo patches and materials

Eligibility Criteria

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

You may qualify if:

• \>= 18 years old
• Daily smoker
• \>=6 cigarettes per day
• Ready to quit within one month
• First time quitline caller
• Valid phone number
• Valid address (no P.O. boxes)
• California resident
• Agree to participate in study and evaluation
• English or Spanish speaking

You may not qualify if:

• Uses other form of tobacco
• Use of Zyban or Chantix
• One of the following conditions: Severe allergy to adhesive tape, Arrhythmia, Angina, Heart attack within last year, Stroke within last year, Uncontrolled high blood pressure, Insulin-dependent diabetes, Pregnancy

Sponsors & Collaborators

• University of California, San Diego: lead
• California Department of Health Services: collaborator

Study Sites (1)

University of Californian, San Diego: California Smokers' Helpline

San Diego, California, 92111, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Cessation; Tobacco Use Disorder

Interventions

Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Principal Investigator
• Organization: UCSD

szhu@ucsd.edu

858-300-1056

Study Officials

• Shu-Hong Zhu, Ph.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 24, 2009
• First Posted: February 25, 2009
• Study Start: February 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2011
• Last Updated: February 13, 2020
• Results First Posted: February 10, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)