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Message Priming and Enrollment in, and Response to, a Smoking Cessation Program: A Pilot Study

This study has been completed.
Sponsor:
Collaborators:
Pennsylvania Department of Health
Pfizer
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00596882
First received: January 8, 2008
Last updated: December 1, 2009
Last verified: December 2009
History of Changes
  Purpose

The proposed study has been designed to examine the effect of a message that primes genetic susceptibility on actual enrollment in a smoking cessation program, actual response to smoking cessation treatment, and potential moderators and mediators of this effect.


Condition Intervention Phase
Smoking Cessation
 Other: Message Prime
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Message Priming and Enrollment in, and Response to, a Smoking Cessation Program: A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • The primary outcome variables are:(1)Attendance to the intake evaluation & enrollment in the smoking cessation program; (2)7-day point prevalence abstinence(3)Self-reported cigarette consumption [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Threat only message. Participants hear information about the negative health consequences of smoking
 Other: Message Prime
Participants will be randomized to genetic prime messages or threat only message at the time of the intial telephone screen. Following phone screen, all eligibleparticipants will receive 13 weeks of Chantix with smoking cessation counseling.
Other: Message Prime
Particpants will be randomized into 1 of 2 groups. 1 group will recieve a message detailing the negative helaht consequenes of smoking and the other group will receive this information along with information about the genetic incluences on smoking behavior.
2
Genetic threat + threat. Participants will bear infomration about genetic influences of smoking in additon to the negative health consequences of smoking.
 Other: Message Prime
Participants will be randomized to genetic prime messages or threat only message at the time of the intial telephone screen. Following phone screen, all eligibleparticipants will receive 13 weeks of Chantix with smoking cessation counseling.
Other: Message Prime
Particpants will be randomized into 1 of 2 groups. 1 group will recieve a message detailing the negative helaht consequenes of smoking and the other group will receive this information along with information about the genetic incluences on smoking behavior.

Detailed Description:

Despite available behavioral and pharmacological interventions to treat nicotine dependence, most smokers do not utilize these interventions. As such, the vast majority of smokers do not capitalize on potentially effective nicotine dependence treatments. The way in which health risk information is presented may influence interest in a smoking cessation program. In a series of preliminary studies, individuals provided with messages that primed the role of genetic variation in susceptibility to addiction to smoking exhibited positive consequences on intentions to quit (Cappella, Lerman, Romantan, & Baruh, 2005). The proposed study has been designed to examine the effect of a message that primes genetic susceptibility on actual enrollment in a smoking cessation program, actual response to smoking cessation treatment, and potential moderators and mediators of this effect. The results of this pilot study may provide preliminary data for a larger trial and have implications for designing interventions to promote utilization of effective treatments for nicotine dependence among smokers.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Eligible participants will be 100 male & female smokers aged 18-65, who smoke ≥ 10 cigarettes/day & who plan to live in the area for the next 6-months.

Key Exclusion Criteria Smoking Behavior

1.Use of chewing tobacco or snuff 2.Current enrollment or plans to enroll in another smoking cessation program in the next 6 months 3.Plan to use other nicotine substitutes or smoking cessation treatments in the next 6 months Alcohol/Drug Exclusion Criteria

  1. History of substance abuse and/or currently receiving treatment for substance abuse
  2. Current alcohol consumption that exceeds >25 standard drinks/week

Medication Exclusion Criteria

  1. Current use or recent discontinuation (within last 14-days) of the following medications:

    1. Any form of smoking cessation medication

    2. Any form of anti-psychotic medications that includes:

      •antipsychotics,

      •atypical antipsychotics,

      •mood-stabilizers,

      •anti-depressants (tricyclics, SSRI's, MAOI's),

      •anti-panic agents,

      •anti-obsessive agents,

      •anti-anxiety agents, and

      • stimulants (e.g., Provigil, Ritalin).
    3. Medication for chronic pain
    4. Anti-coagulants
    5. Any heart medications
    6. Daily medication for asthma

Medical Exclusion Criteria

  1. Women who are pregnant, planning a pregnancy, or lactating.
  2. History or current diagnosis of psychosis, major depression or bipolar disorder, schizophrenia, or any Axis 1 disorder.
  3. Serious/unstable disease within the past 6 months (e.g., cancer [but melanoma], heart disease, HIV).
  4. History of epilepsy or a seizure disorder.
  5. History or current diagnosis (last 6-months) of abnormal rhythms and/or tachycardia (>100 beats/minute); history or current diagnosis of COPD, cardiovascular disease (stroke, angina, coronary heart disease), heart attack in the last 6 months, uncontrolled hypertension (SBP>150 or DBP>90).
  6. History of kidney and/or liver failure (including transplant).

General Exclusion

  1. Any medical condition or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.
  2. Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00596882

Locations
United States, Pennsylvania
Transdisciplinary Tobacco Use Research Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Pennsylvania Department of Health
Pfizer
Investigators
Principal Investigator: Robert Schnoll, Ph.D. University of Pennsylvania
  More Information

No publications provided

Responsible Party: Robert Schnoll, Ph.D., University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00596882     History of Changes
Other Study ID Numbers: 806910
Study First Received: January 8, 2008
Last Updated: December 1, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
smoking cessation
nicotine dependence
message prime
recruitment

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 23, 2013