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

NCT00706979 | Completed Results

• 1 other identifier: 1R01DA021619-01A1
• Study Type: interventional
• Target: 849
• Locations: 0 countries
• Sites: N/A

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. 1.Practice Quit Attempt (PQA) aided by brief advice and self-help materials, or
2. 2.PQA aided by advice and self-help materials plus nicotine replacement therapy (NRT).

Conditions

Smoking; Smoking Cessation

Keywords

smoking; smoking cessation; nicotine replacement therapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• 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

• 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

Study Arms (2)

1

EXPERIMENTAL

Practice Quit Attempt plus Nicotine Replacement Therapy

Other: Practice Quit Attempt plus nicotine lozenge

2

ACTIVE COMPARATOR

Practice Quit Attempt only

Behavioral: Practice Quit Attempt only

Interventions

Practice Quit Attempt plus nicotine lozenge OTHER

nicotine lozenge, 2 mg or 4 mg

Also known as: Nicotine lozenge, Nicotine Replacement Therapy (NRT)

1

Practice Quit Attempt only BEHAVIORAL

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator

Related Publications (1)

• 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.

  PMID: 22123796 DERIVED

MeSH Terms

Conditions

Smoking; Smoking Cessation

Interventions

Tobacco Use Cessation Devices; Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Drug Therapy

Results Point of Contact

• Title: Matthew J. Carpenter
• Organization: Medical University of South Carolina'

carpente@musc.edu

843-792-3974

Study Officials

• Matthew J Carpenter, Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2008
• First Posted: June 30, 2008
• Study Start: September 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: December 9, 2011
• Results First Posted: December 9, 2011

Record last verified: 2010-10