Smoking Cessation With the Nicotine Patch: A Pilot Study of Patch Messaging

NCT01287377 | Completed Phase 3 Results

• 1 other identifier: 100683
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to test the feasibility of sending pre-cessation nicotine patches and to examine the effects associated with the pre-cessation treatment phase. Specifically, this study aims to:

1. 1.See if subjects will use pre-cessation nicotine patches.
2. 2.See if subjects in the pre-cessation nicotine patches go on to get more nicotine patches.
3. 3.See if pre-cessation treatment with nicotine patches leads to a decrease in number of cigarettes smoked per day.
4. 4.See if sending 2-weeks' worth of patches is helpful to the quitting process.

Conditions

Smoking Cessation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Have Not Used Tobacco in the Past 30 Days

  At a given point in time (in this case, 2 months after program registration), quitline participants are asked whether they have used cigarettes or other forms of tobacco in the past 30 days. Those who reply that they have not used tobacco in the past 30 days are considered to have quit.

  2-months post enrollment

Secondary Outcomes (1)

• Number of Participants With Serious Quit Attempts

  2-months post enrollment

Study Arms (3)

Pre-Patch and Telephone Counseling

EXPERIMENTAL

Nicotine patches (2 weeks' worth) are mailed directly to the subject. Clients will be encouraged to start using these patches PRIOR to their quit date. Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.

Behavioral: Telephone Counseling; Drug: Nicotine Patches

Post-Patch and Telephone Counseling

ACTIVE COMPARATOR

Nicotine patches (2 weeks' worth) are mailed directly to the subject. Clients are encouraged to start using their patches ON their quit date. Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.

Behavioral: Telephone Counseling; Drug: Nicotine Patches

Telephone Counseling and no patches sent

ACTIVE COMPARATOR

Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.

Behavioral: Telephone Counseling

Interventions

Telephone Counseling BEHAVIORAL

Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.

Post-Patch and Telephone Counseling; Pre-Patch and Telephone Counseling; Telephone Counseling and no patches sent

Nicotine Patches DRUG

Subjects are randomized into one of these pharmacotherapy interventions: direct mailing of active patches with a message to start using it on their quit date, direct mailing of active patches with a message to start using it right away, or usual care patches in which no patches are sent directly (although clients may still get them through their usual channels). For those in the usual care condition, patches will not be mailed directly to them; however, we will facilitate their use by providing a certificate that can be used by the State Medicaid program and some other insurance companies to obtain free patches. For those in the active condition, we will mail 2 weeks of patches directly to their home. All subjects will receive a 2 week starter kit with fourteen 21mg patches.

Also known as: Habitrol

Post-Patch and Telephone Counseling; Pre-Patch and Telephone Counseling

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
• \>=10 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 speaking

You may not qualify if:

• Uses other form of tobacco
• Plan to use quitting aids other than nicotine patch
• Has any of the following conditions:
• Severe allergy to adhesive tape
• Arrhythmia
• Angina
• Heart attack within last 6 months
• Stroke within last 6 months
• Uncontrolled high blood pressure
• Insulin-dependent diabetes
• Pregnancy

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

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: Dr. Shu-Hong Zhu
• Organization: UCSD

szhu@ucsd.edu

8583001056

Study Officials

• Shu-Hong Zhu, Ph.D.

  UCSD

  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: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 28, 2011
• First Posted: February 1, 2011
• Study Start: November 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 13, 2020
• Results First Posted: October 1, 2019

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)