Evaluation of Learning-Theory-Based Smoking Cessation Strategies

NCT01368653 | Completed Results

• 2 other identifiers: DA0265111R21DA026511-01A1
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial tested whether a new treatment designed to help smokers prepare to quit smoking by practicing quitting several times helped more smokers quit and stay quit than standard treatment with nicotine patch and smoking cessation counseling. The practice quitting treatment tested involved quitting for progressively longer periods of time tailored to individual patterns of smoking. This clinical trial also tested whether non-nicotine cigarettes can help smokers become smoke free after slipping during a stop smoking attempt.

Conditions

Nicotine Dependence

Keywords

Tobacco; Smoking; Smoking Cessation; Tobacco Dependence; Tobacco Use; Nicotine Dependence

Outcome Measures

Primary Outcomes (1)

• 4-week Abstinence

  7-day point prevalence abstinence captures whether participants have used tobacco in the past 7 days at the 4-week post-quit follow-up (i.e., whether any tobacco use occurred in the 4th week of the quit attempt).

  4 weeks

Secondary Outcomes (3)

• 10-week Abstinence

  10 weeks

• Mediators of Treatment Effects: Confidence in Quitting in the Weeks Leading up to the Target Quit Date

  3 weeks pre-quit

• Prolonged Abstinence

  10 weeks

Study Arms (4)

Standard treatment

ACTIVE COMPARATOR

In this arm, smokers receive a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking

Behavioral: Standard treatment

Standard treatment+practice quitting

EXPERIMENTAL

In this arm, participants receive standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.

Behavioral: Standard treatment+practice quitting

Very low nicotine cigarettes

EXPERIMENTAL

In this condition, smokers from both the Standard treatment and the Standard treatment+practice quitting arms who have smoked in the last 7-days at a 4-week post-target-smoking-cessation-date follow-up interview may be randomly assigned to this group. Those assigned to this group will receive a 6-week supply of cigarettes that contain tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine. This treatment is designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking

Drug: Very low nicotine cigarettes

Advice and encouragement only

NO INTERVENTION

In this condition, smokers from both the Standard treatment and the Standard treatment+practice quitting arms who have smoked in the last 7-days at a 4-week post-target-smoking-cessation-date follow-up interview may be randomly assigned to this condition. Those in this arm will receive advice and encouragement to try to stop smoking again after they have slipped (returned to smoking) during a stop smoking attempt.

Interventions

Standard treatment BEHAVIORAL

Standard treatment includes a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking

Also known as: Nicotine patch

Standard treatment

Standard treatment+practice quitting BEHAVIORAL

This intervention includes standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling

Also known as: Nicotine patch

Standard treatment+practice quitting

Very low nicotine cigarettes DRUG

This intervention will be offered to a subset of smokers from both of the other study arms. To be eligible for this intervention, participants must be smoking at the follow-up interview conducted four weeks after a target quit day in the two arms listed above. Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These are to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks.

Very low nicotine cigarettes

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Smoke cigarettes daily
• Motivated to quit smoking
• Able to read and write English
• Willing and able to complete study visits and cell phone calls

You may not qualify if:

• Pregnancy, breastfeeding, planning on becoming pregnant during the study
• Recent heart attack or heart surgery, heart disease, unstable angina
• Allergy to adhesives
• Past negative reactions to nicotine patch
• Serious skin conditions

Sponsors & Collaborators

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

Study Sites (1)

Rutgers University Institute for Health, Health Care Policy, and Aging Research

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking; Smoking Cessation; Tobacco Use

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Limitations and Caveats

The sample comprised adult treatment-seeking smokers who met inclusion criteria and were willing to participate in a randomized controlled trial involving intensive assessment and offering substantial compensation. The degree to which results will generalize to medically or mentally ill smokers is unknown. Neither participants nor researchers were blind to condition assignment. All abstinence outcomes were based on self-report rather than biochemical verification.

Results Point of Contact

• Title: Danielle E. McCarthy, Ph.D.
• Organization: Rutgers, The State University of New Jersey

demccarthy@wisc.edu

608-265-5949

Study Officials

• Danielle E McCarthy, Ph.D.

  Rutgers University

  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: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 8, 2011
• Study Start: June 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2013
• Last Updated: April 27, 2022
• Results First Posted: November 18, 2014

Record last verified: 2022-03

Locations

US (1)