Providing Free Nicotine Patches to Quitline Smokers

NCT01736085 | Completed Phase 3 Results

• 1 other identifier: P121218
• Study Type: interventional
• Target: 3,706
• Locations: 1 country
• Sites: 1

Brief Summary

The California Smokers' Helpline will conduct a 3 X 2 (nicotine patch by counseling condition) randomized trial to test the provision of nicotine patches to help smokers calling a telephone quitline. The study assesses one factor related to nicotine patches with 3 levels: sending patches directly from the Helpline, providing vouchers that can be redeemed for patches, and usual care. A second factor is counseling plus materials versus materials only. This proposed study has the following specific aims:

1. 1.To demonstrate that a voucher for free nicotine patches will increase the quit rate for smokers who do not have access to free nicotine replacement therapy (NRT)
2. 2.To demonstrate that sending patches directly from a quitline would outperform sending vouchers for free NRT, since the vouchers impose an additional barrier to those who want to quit
3. 3.To determine the effect of telephone counseling in the context of nicotine patch distribution and if any interaction effects exist between counseling and patch conditions

Conditions

Smoking Cessation

Keywords

tobacco cessation; smoking cessation; nicotine; telephone counseling; self-help; smoking abstinence; tobacco use disorder; nicotine replacement therapy; voucher

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Six Months Prolonged Abstinence

  At seven months post enrollment we will conduct a brief telephone survey to assess smoking status. The information obtained will allow us to determine six month prolonged abstinence rates.

  Seven months post enrollment

Secondary Outcomes (1)

• Percentage of Smokers Making a 24-hour Quit Attempt

  Two months post enrollment

Study Arms (6)

Material Group

NO INTERVENTION

Subjects will receive self-help materials

Materials plus Voucher

ACTIVE COMPARATOR

Subjects will receive self-help materials and a voucher for 2 week's worth of nicotine patches

Behavioral: Voucher

Materials plus Patches

ACTIVE COMPARATOR

Subjects will receive self-help materials and a 2 week's worth of nicotine patches

Drug: Nicotine patches

Counseling

ACTIVE COMPARATOR

Subjects will receive up to 5 sessions of telephone counseling

Behavioral: Telephone counseling

Counseling plus Voucher

ACTIVE COMPARATOR

Subjects will receive up to 5 sessions of telephone counseling plus a voucher for 2 week's worth of nicotine patches.

Behavioral: Telephone counseling; Behavioral: Voucher

Counseling plus Patches

ACTIVE COMPARATOR

Subjects will receive up to 5 sessions of telephone counseling plus 2 week's worth of nicotine patches.

Behavioral: Telephone counseling; Drug: Nicotine patches

Interventions

Telephone counseling BEHAVIORAL

Telephone counseling is conducted in the appropriate language (English and Spanish) by veteran counselors at the California Smokers' Helpline. Subjects will receive free proactive telephone counseling to help them set up quit smoking plans. The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. It includes a 30-minute comprehensive pre-quit session (motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four 10-minute proactive follow-up calls. The counseling protocol has several distinguishing features: proactive follow-up counseling calls, a manualized (i.e., semi-structured) protocol and relapse-sensitive scheduling

Counseling; Counseling plus Patches; Counseling plus Voucher

Voucher BEHAVIORAL

Subjects will receive a voucher for nicotine patches. Subjects randomized into the voucher condition will receive a voucher that can be exchanged for two weeks' worth of free starter kit nicotine patches by calling a dedicated phone number (Quit Boost). The voucher will be mailed the day after the screening intake. Subjects who smoke 11 or more cigarettes per day will receive 21 mg patches; smoke 10 or less per day will receive 14 mg patches. Subjects will be encouraged to start using these patches on their quit date.

Also known as: Voucher for nicotine patch

Counseling plus Voucher; Materials plus Voucher

Nicotine patches DRUG

Subjects will receive nicotine patches directly sent to their home. Subjects randomized into the patch condition will receive two weeks' worth of free starter kit nicotine patches directly. The patches will be mailed directly to their home the day after screening intake. Subjects who smoke 11 or more cigarettes per day will receive 21 mg patches; smoke 10 or less per day will receive 14 mg patches. Subjects will be encouraged to start using these patches on their quit date.

Also known as: Nicotine patches sent directly

Counseling plus Patches; Materials plus Patches

Eligibility Criteria

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

You may qualify if:

• years or older
• Current smoker
• First time quitline caller
• Not eligible for nicotine patches through other programs such as MediCal or Los Angeles County which provides free nicotine patches
• English and/or Spanish speaking
• Valid phone number
• Valid address
• CA resident
• Gave consent to participate in study and evaluation

You may not qualify if:

• Contraindication(s) to nicotine patches
• Uses a form of tobacco other than cigarettes
• Plans to use Chantix

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego; California Smokers' Helpline

San Diego, California, 92111, United States

Location

Related Publications (3)

• Zhu SH, Anderson CM, Tedeschi GJ, Rosbrook B, Johnson CE, Byrd M, Gutierrez-Terrell E. Evidence of real-world effectiveness of a telephone quitline for smokers. N Engl J Med. 2002 Oct 3;347(14):1087-93. doi: 10.1056/NEJMsa020660.

  PMID: 12362011 BACKGROUND

• Anderson CM, Zhu SH. Tobacco quitlines: looking back and looking ahead. Tob Control. 2007 Dec;16 Suppl 1(Suppl 1):i81-6. doi: 10.1136/tc.2007.020701.

  PMID: 18048638 BACKGROUND

• Cummings KM, Fix BV, Celestino P, Hyland A, Mahoney M, Ossip DJ, Bauer U. Does the number of free nicotine patches given to smokers calling a quitline influence quit rates: results from a quasi-experimental study. BMC Public Health. 2010 Apr 7;10:181. doi: 10.1186/1471-2458-10-181.

  PMID: 20374628 BACKGROUND

Related Links

• California Smokers' Helpline, University of California, San Diego

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Cessation; Tobacco Use Disorder

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Principal Investigator
• Organization: UCSD

szhu@ucsd.edu

8583001056

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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: November 29, 2012
• Study Start: April 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: February 19, 2020
• Results First Posted: February 19, 2020

Record last verified: 2020-02

Locations

US (1)