Smoking Cessation With the Nicotine Patch: A Pilot Study of Patch Messaging
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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:
- See if subjects will use pre-cessation nicotine patches.
- See if subjects in the pre-cessation nicotine patches go on to get more nicotine patches.
- See if pre-cessation treatment with nicotine patches leads to a decrease in number of cigarettes smoked per day.
- 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 |
- 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.
- 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: Active Pre-Patches and Telephone Counseling |
Behavioral: Telephone Counseling
Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomized into the study. Reading materials and written consent will be mailed to all study subjects the following business day. All subjects receive telephone counseling. Telephone counseling includes a comprehensive pre-quit session (to include motivation, planning, and setting of a quit date and the discussion of nicotine patch use) plus up to 4 proactive follow-up calls. Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. 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. |
| Active Comparator: Active Post-Patches and Telephone Counseling |
Behavioral: Telephone Counseling
Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomized into the study. Reading materials and written consent will be mailed to all study subjects the following business day. All subjects receive telephone counseling. Telephone counseling includes a comprehensive pre-quit session (to include motivation, planning, and setting of a quit date and the discussion of nicotine patch use) plus up to 4 proactive follow-up calls. Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. 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. |
| Active Comparator: Usual care - no patches sent and Telephone Counseling |
Behavioral: Telephone Counseling
Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomized into the study. Reading materials and written consent will be mailed to all study subjects the following business day. All subjects receive telephone counseling. Telephone counseling includes a comprehensive pre-quit session (to include motivation, planning, and setting of a quit date and the discussion of nicotine patch use) plus up to 4 proactive follow-up calls. Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. |
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:
- Subjects will use pre-cessation nicotine patches.
- Subjects in the pre-cessation nicotine patches go on to get more nicotine patches.
- Pre-cessation treatment with nicotine patches leads to a decrease in number of cigarettes smoked per day.
- 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 |
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| United States, California | |
| University of California San Diego | |
| San Diego, California, United States, 92111 | |
| 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: | June 27, 2012 |
| 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:
|
Smoking Habits Nicotine Nicotine polacrilex 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 Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013