Clinical trial NCT00706979: A Novel Treatment to Boost Quit Attempts and Cessation Among Unmotivated Smokers
Official title: A Novel Treatment to Boost Quit Attempts and Cessation Among Unmotivated Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Smoking Cessation
Keywords: smoking
smoking cessation
nicotine replacement therapy
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-06-30
Enrollment: 849
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking
timeFrame: From study enrollment through six month follow-up
measure: A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking
timeFrame: From study enrollment through six month follow-up
Secondary outcomes:
measure: Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days
timeFrame: At any point during the study
measure: Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days
timeFrame: At 6-month follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of South Carolina
name: Matthew J Carpenter, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carpenter MJ, Hughes JR, Gray KM, Wahlquist AE, Saladin ME, Alberg AJ. Nicotine therapy sampling to induce quit attempts among smokers unmotivated to quit: a randomized clinical trial. Arch Intern Med. 2011 Nov 28;171(21):1901-7. doi: 10.1001/archinternmed.2011.492.