Skip to main content
OpenTrials
Completed

NCT Number: NCT00706979

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Practice Quit Attempt plus nicotine lozenge

Other

nicotine lozenge, 2 mg or 4 mg

Other names: Nicotine lozenge, Nicotine Replacement Therapy (NRT)

Practice Quit Attempt only

Behavioral

Practice Quit Attempts (PQA) message aided by brief advice and self-help materials

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 30, 2008
Registry last updated
Dec 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.