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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00706979
• Other study ID #: 1R01DA021619-01A1
• Secondary ID: 1R01DA021619-01A
• Status: Completed
• Phase: N/A
• First received: June 26, 2008
• Last updated: November 7, 2011
• Start date: September 2008
• Est. completion date: October 2010

Study information

• Verified date: October 2010
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 849
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking
• Smoking Cessation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Drug Abuse (NIDA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking	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.	From study enrollment through six month follow-up	No
Primary	A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking	Serious quit attempt of >=24hrs, which fits the CDC's definition of a quit attempt.	From study enrollment through six month follow-up	No
Secondary	Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days		At any point during the study	No
Secondary	Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days		At 6-month follow-up	No