Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Study Primary Completion Date: March 2010

Intervention(s) in this Clinical Trial

• Other: Practice Quit Attempt plus nicotine lozenge
  • nicotine lozenge, 2 mg or 4 mg
• Behavioral: Practice Quit Attempt only
  • Practice Quit Attempts (PQA) message aided by brief advice and self-help materials

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Practice Quit Attempt plus Nicotine Replacement Therapy
• Active Comparator: 2
  • Practice Quit Attempt only

Primary Measures

• A serious quit attempt in which the participant intends to permanently stop smoking
  • Time Frame: From study enrollment through six month follow-up
    Safety Issue?: No

Secondary Measures

• 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
    Safety Issue?: No

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Matthew J Carpenter, Ph.D. Principal Investigator Medical University of South Carolina  

Overall Contact: Amy Boatright 800-375-0516 boatrigh@musc.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00706979

Study ID Number: 1R01DA021619-01A1

ClinicalTrials.gov Identifier: NCT00706979

Health Authority: United States: Institutional Review Board