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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shu-Hong Zhu, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01287377
First received: January 28, 2011
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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

Condition Intervention Phase
Smoking Cessation
Behavioral: Telephone Counseling
Drug: Nicotine Patches
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Smoking Cessation With the Nicotine Patch: A Pilot Study of Patch Messaging

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Continuous abstinence from cigarettes [ Time Frame: 2-months post enrollment ] [ Designated as safety issue: No ]
    All participants will receive one Assessment Interviews at 2-months after their initial contact with the Helpline. The interview will cover, as appropriate, tobacco use, use of quitting aids, pattern of quitting (including slips and relapse situations), and satisfaction with the services. The interview will be conducted over the telephone. Participants will receive a pre-contact letter 1 week before the evaluation interview with a non-contingent $2 bill incentive.


Secondary Outcome Measures:
  • Rate of serious quit attempts [ Time Frame: 2-months post enrollment ] [ Designated as safety issue: No ]
  • 30-day point prevalence [ Time Frame: 2-months post enrollment ] [ Designated as safety issue: No ]

Enrollment: 243
Study Start Date: November 2010
Study Completion Date: November 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pre-Patch and Telephone Counseling

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
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.
Drug: Nicotine Patches

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.

Other Name: Habitrol
Active Comparator: Post-Patch and Telephone Counseling

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
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.
Drug: Nicotine Patches

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.

Other Name: Habitrol
Active Comparator: Telephone Counseling and no patches sent
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
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.

Detailed Description:

Quitlines have become central to state tobacco control efforts in the U.S. In addition to offering telephone counseling, many quitlines have begun providing quitting aids (e.g., nicotine patch) to eligible smokers. The nicotine patch has been shown repeatedly to double the rate of quitting success compared to a placebo control. Recently a number of studies have examined the use of patches prior to quitting. A meta-analysis indicates that such pre-cessation treatment with nicotine patches doubles the odds of quitting, compared to starting patch treatment on the quit day, as is traditionally done.

The proposed study would look at both pre-cessation treatment with nicotine patches as well as looking to see if sending clients nicotine patches is helpful in their quitting process. The rationale for pre-cessation treatment with patches is that using patches in this manner would make it easier to quit smoking because it may: reduce the reinforcing effects of cigarette smoking, thus helping to overcome conditioned behavior; reduce the need for inhaled nicotine as smokers naturally decrease their cigarette consumption to titrate the level of nicotine in their system; and/or increase compliance with patch use in the quitting phase.

The rationale for sending nicotine patches is that when callers must go and get the patches on their own it creates a barrier to their quitting so that sending nicotine patches directly to a callers' home would make it easier for them to stay on task and quit. This pilot will allow us to test the feasibility of sending pre-treatment nicotine patches and to examine the effects associated with the pre-cessation treatment phase.

This pilot project has the following specific aims, to examine whether:

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

Results will add to the theoretical understanding of behavior change from which new, effective interventions can spring.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >= 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)
  • CA resident
  • Agree to participate in study and evaluation
  • English speaking

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01287377

Locations
United States, California
University of California San Diego
San Diego, California, United States, 92111
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Shu-Hong Zhu, Ph.D. UCSD
  More Information

No publications provided

Responsible Party: Shu-Hong Zhu, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01287377     History of Changes
Other Study ID Numbers: 100683
Study First Received: January 28, 2011
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
tobacco cessation
smoking cessation
nicotine
counseling
telephone
self-help
smoking abstinence
tobacco use disorder
nicotine replacement therapy

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014