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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00706979
First received: June 26, 2008
Last updated: November 7, 2011
Last verified: October 2010
  Purpose

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 Intervention
Smoking
Smoking Cessation
Other: Practice Quit Attempt plus nicotine lozenge
Behavioral: Practice Quit Attempt only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Novel Treatment to Boost Quit Attempts and Cessation Among Unmotivated Smokers

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking [ Time Frame: From study enrollment through six month follow-up ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    Serious quit attempt of >=24hrs, which fits the CDC's definition of a quit attempt.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 849
Study Start Date: September 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00706979

Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Matthew J Carpenter, Ph.D. Medical University of South Carolina
  More Information

No publications provided by Medical University of South Carolina

Additional 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, 1R01DA021619-01A1
Study First Received: June 26, 2008
Results First Received: November 7, 2011
Last Updated: November 7, 2011
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Medical University of South Carolina:
smoking
smoking cessation
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 April 17, 2014