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

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Smoking; Smoking Cessation

Treatments: Behavioral: Practice Quit Attempt only; Other: Practice Quit Attempt plus nicotine lozenge

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00706979

1R01DA021619-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 849 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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849 participants in 2 patient groups

1

Experimental group

Description:

Practice Quit Attempt plus Nicotine Replacement Therapy

Treatment:

Other: Practice Quit Attempt plus nicotine lozenge

2

Active Comparator group

Description:

Practice Quit Attempt only

Treatment:

Behavioral: Practice Quit Attempt only