Low-Cost Contingency Management for Smoking Cessation

NCT01040260 | Completed Results

• 1 other identifier: 17RT-0081
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

An innovative low-cost form of contingency management has been developed in which participants receive the chance to draw vouchers from a fish bowl depending on whether or not their abstinence from tobacco is confirmed by expired-air carbon monoxide. The vouchers can be redeemed for prizes of varying value. This form of contingency management has been shown to be effective in the treatment of a variety of substance use disorders, but has not been investigated in a clinical trial focusing on smoking cessation. Thus, the primary purpose of the proposed study will be to investigate the effects of a low-cost prize-based form of contingency management in the treatment of nicotine dependence. To accomplish this objective, we enrolled 103 current smokers into the study. The participants in Study Arm 1 received the contingency management intervention for 8 weeks, and the participants in Study Arm 2 had their smoking status assessed but did not receive the contingency management intervention. Both interventions received brief counseling and nicotine replacement therapy. The counseling was conducted in two 60-minute individual sessions scheduled one week apart with two follow-up phone calls at weeks 3, 4, and 6. The primary outcome for this study was biochemically-validated smoking status at 3 months (end of treatment), and at 6- and 12-month follow-up. Both continuous and point-prevalent abstinence rates were determined. Saliva cotinine levels were measured in all participants reporting abstinence at each assessment. This study had 80% power to detect a 10% absolute difference in smoking cessation rates between the two treatment conditions (i.e., a 28% quit rate in Study Arm 1 versus a 18% quit rate in Study Arm 2) with alpha set at 0.05. These estimates included an anticipated 15% loss to follow-up over the 12-month study period.

Conditions

Tobacco Use Cessation

Keywords

tobacco use disorder

Outcome Measures

Primary Outcomes (1)

• Abstinence Rate

  Number of participants who abstained from smoking during the 7 day period verified by CO testing

  52 weeks

Study Arms (2)

Contingency management

EXPERIMENTAL

Use of tangible rewards for verified abstinence

Behavioral: Contingency management

Counseling plus nicotine patches

ACTIVE COMPARATOR

Counseling plus nicotine patches

Other: Counseling; Drug: Nicotine patches

Interventions

Counseling OTHER

Smoking cessation counseling

Also known as: Smoking cessation counseling

Counseling plus nicotine patches

Contingency management BEHAVIORAL

Use of tangible rewards for abstinence from smoking

Also known as: Low-cost contingency management

Contingency management

Nicotine patches DRUG

Nicotine patches

Also known as: Nicotine replacement

Counseling plus nicotine patches

Eligibility Criteria

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

You may qualify if:

• Smoke at least 5 cigarettes per day
• Interested in quitting

You may not qualify if:

• Cognitive impairment or unstable psychotic disorder that would significantly interfere with the individual's ability to participate in the study.
• Self-reported problem with alcohol or other drugs during the past three months
• Current use of any smoking cessation medication
• Presence of any contraindications for nicotine patches, lozenges, or gum
• Pregnancy

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

VA Medical Center

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Tobacco Use Cessation; Tobacco Use Disorder

Interventions

Counseling; Tobacco Use Cessation Devices; Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Therapeutics; Drug Therapy

Results Point of Contact

• Title: Dr. Timothy Carmody
• Organization: University of California, San Francisco

Timothy.Carmody@ucsf.edu

(415) 221-4810

Study Officials

• Timothy P Carmody, Ph.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: December 27, 2009
• First Posted: December 29, 2009
• Study Start: June 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 6, 2018
• Results First Posted: August 30, 2013

Record last verified: 2018-05

Locations

US (1)