Gradual vs. Abrupt Cessation Treatment for Smoking

NCT00297492 | Completed Phase 2 Results

• 1 other identifier: R01DA011557-07
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

This study tests whether stopping smoking by gradually cutting down first is more or less successful than stopping abruptly. We hypothesize that stopping by gradually cutting down first will produce more abstinence than stopping abruptly.

Conditions

Smoking Cessation

Keywords

Smoking Cessation; Tobacco

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement

  Number of participants with self-reported prolonged abstinence from cigarette smoking through 6 months of follow-up, verified by a breath carbon monoxide reading of less than 10 parts per million

  6 months

Study Arms (3)

Gradual reduction

EXPERIMENTAL

Intervention: Reduction Phone Counseling. Intervention: Pre-Quit Nicotine Lozenges. Intervention: Post-Quit Nicotine Lozenges.

Behavioral: Reduction Phone Counseling; Drug: Pre-Quit Nicotine Lozenges; Drug: Post-Quit Nicotine Lozenges

Abrupt cessation

ACTIVE COMPARATOR

Intervention: Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges.

Behavioral: Abrupt Phone Counseling; Drug: Post-Quit Nicotine Lozenges

Minimal intervention

ACTIVE COMPARATOR

Intervention: Minimal Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges.

Behavioral: Minimal Abrupt Phone Counseling; Drug: Post-Quit Nicotine Lozenges

Interventions

Reduction Phone Counseling BEHAVIORAL

Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date. This includes 5 counseling calls: 3 calls focused on reduction prior to the quit date, 1 call two days prior to the quit date to discuss common strategies for preparing to quit, and 1 call two days after the quit date to discuss relapse prevention. Telephone counseling also discusses the proper use of nicotine lozenges during reduction and after the quit date.

Gradual reduction

Abrupt Phone Counseling BEHAVIORAL

Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date. This includes 5 counseling calls: 1 to set a quit date, 1 two days prior to the quit date to discuss common strategies for preparing to quit, and 3 after the quit date to discuss relapse prevention. Telephone counseling also discusses the proper use of nicotine lozenges after the quit date.

Abrupt cessation

Minimal Abrupt Phone Counseling BEHAVIORAL

Minimal counseling to mimic intervention at a primary care office. This includes 2 counseling calls: 1 to set a quit date and 1 two days after the quit date to discuss relapse prevention. Telephone counseling also discusses the proper use of nicotine lozenges after the quit date.

Minimal intervention

Pre-Quit Nicotine Lozenges DRUG

2 mg lozenges for participants usually smoke their first cigarette more than 30 minutes after awaking. 4 mg lozenge for participants who usually smoke their first cigarette less than 30 minutes after awaking. Replace each forgone cigarette during reduction with one lozenge. Use additional lozenges to combat cravings to smoke.

Also known as: Commit Nicotine Lozenges

Gradual reduction

Post-Quit Nicotine Lozenges DRUG

2 mg lozenges for participants usually smoke their first cigarette more than 30 minutes after awaking. 4 mg lozenge for participants who usually smoke their first cigarette less than 30 minutes after awaking. Replace each forgone cigarette while abstinent with one lozenge. Use additional lozenges to combat cravings to smoke.

Also known as: Commit Nicotine Lozenges

Abrupt cessation; Gradual reduction; Minimal intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Interested in quitting gradually
• At least 18 years old
• Daily cigarette smoker
• Smoke at least 15 cigarettes per day (CPD)
• No change greater than 20% in CPD in the last month
• Interested in quitting in next 30 days
• Must agree to not use non-cigarette tobacco during study
• No use of smoking cessation medication in last month
• Have phone with voice mail
• Willing to use nicotine lozenge
• No other person in household in study
• Fluent/literate in English

You may not qualify if:

• Women who are pregnant or breastfeeding
• Currently using medication for depression or asthma
• Heart disease requiring medication
• Heart attack in last month
• Irregular heartbeat
• High blood pressure not controlled by medication
• Stomach ulcers
• Diabetes

Sponsors & Collaborators

• University of Vermont: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Vermont Human Behavioral Pharmacology Lab

Burlington, Vermont, 05401, United States

Location

Related Publications (1)

• Hughes JR, Solomon LJ, Livingston AE, Callas PW, Peters EN. A randomized, controlled trial of NRT-aided gradual vs. abrupt cessation in smokers actively trying to quit. Drug Alcohol Depend. 2010 Sep 1;111(1-2):105-13. doi: 10.1016/j.drugalcdep.2010.04.007. Epub 2010 May 26.

  PMID: 20537810 RESULT

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Limitations and Caveats

Our projected incidence of abstinence was higher than what was actually observed, leading to lower statistical power than expected.

Results Point of Contact

• Title: Dr. John Hughes
• Organization: University of Vermont

John.Hughes@uvm.edu

802-656-9610

Study Officials

• John Hughes, MD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: February 24, 2006
• First Posted: February 28, 2006
• Study Start: January 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: September 20, 2013
• Results First Posted: September 5, 2012

Record last verified: 2013-09

Locations

US (1)