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A Novel Treatment to Boost Quit Attempts and Cessation Among Unmotivated Smokers

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ClinicalTrials.gov Identifier: NCT00706979
Recruitment Status : Completed
First Posted : June 30, 2008
Results First Posted : December 9, 2011
Last Update Posted : December 9, 2011
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:

A sample of smokers who have no current plans to quit will be recruited for this study and randomized to one of two intervention conditions:

  1. Practice Quit Attempt (PQA) aided by brief advice and self-help materials, or
  2. PQA aided by advice and self-help materials plus nicotine replacement therapy (NRT).

This study will test whether adding free nicotine replacement therapy to brief advice to undertake a practice quit attempt will motivate more smokers to make a serious attempt to stop smoking than brief advice without NRT. All treatments and assessments will be delivered via telephone and mailing. The primary outcome of interest is the incidence of a serious attempt to permanently stop smoking made over a six-month study period.

Our specific hypotheses are as follows:

Hypothesis 1: Helping smokers to make a practice quit attempt aided by NRT will result in a higher incidence of making a serious effort to quit smoking permanently, compared to an aided practice quit attempt without NRT. We also expect provision of NRT will increase point prevalence abstinence at 6 month follow-up.

Hypothesis 2: This relationship between NRT-aided practice quit attempts and quit behaviors will be mediated by a) increased smoking related self efficacy, b) increased belief in the efficacy of NRT, c) fewer concerns about adverse events of NRT, d) increased social support for not smoking, and e) less withdrawal distress and craving during the practice quit attempt.


Condition or disease Intervention/treatment Phase
Smoking Smoking Cessation Other: Practice Quit Attempt plus nicotine lozenge Behavioral: Practice Quit Attempt only Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 849 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Novel Treatment to Boost Quit Attempts and Cessation Among Unmotivated Smokers
Study Start Date : September 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: 1
Practice Quit Attempt plus Nicotine Replacement Therapy
Other: Practice Quit Attempt plus nicotine lozenge
nicotine lozenge, 2 mg or 4 mg
Other Names:
  • Nicotine lozenge
  • Nicotine Replacement Therapy (NRT)

Active Comparator: 2
Practice Quit Attempt only
Behavioral: Practice Quit Attempt only
Practice Quit Attempts (PQA) message aided by brief advice and self-help materials




Primary Outcome Measures :
  1. A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking [ Time Frame: From study enrollment through six month follow-up ]
    The primary outcome was an attempt to quit smoking for good. To distinguish from a PQA, we specifically asked participants if they tried to quit smoking with the intent of quitting for good. Quit attempts were defined as any self-defined attempt to quit for good.

  2. A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking [ Time Frame: From study enrollment through six month follow-up ]
    Serious quit attempt of >=24hrs, which fits the CDC's definition of a quit attempt.


Secondary Outcome Measures :
  1. Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days [ Time Frame: At any point during the study ]
  2. Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days [ Time Frame: At 6-month follow-up ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current cigarette smoker of at least 10 cigarettes per day
  • Interested in quitting at some time
  • Not currently interested in quitting smoking
  • Access to telephone (home or work) for 6 month study period

Exclusion Criteria:

  • Monthly cigar, pipe, or smokeless tobacco use
  • Current pregnancy or breastfeeding
  • Recent cardiovascular distress
  • Phenylketonuria (PKU)
  • Previous use of nicotine replacement therapy (gum, patch, lozenge, inhaler, or nasal spray)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00706979


Sponsors and Collaborators
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Matthew J Carpenter, Ph.D. Medical University of South Carolina

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00706979     History of Changes
Other Study ID Numbers: 1R01DA021619-01A1 ( U.S. NIH Grant/Contract )
1R01DA021619-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 30, 2008    Key Record Dates
Results First Posted: December 9, 2011
Last Update Posted: December 9, 2011
Last Verified: October 2010

Keywords provided by Medical University of South Carolina:
smoking
smoking cessation
nicotine replacement therapy

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