Skip to main content
OpenTrials
Completed

NCT Number: NCT01040260

Low-Cost Contingency Management for Smoking Cessation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Medical Center

San Francisco, California, 94121, United States

About this study

Contingency management as a treatment for substance use disorders involves the use of tangible rewards for confirmed abstinence. There is preliminary evidence that contingency management shows promise as a smoking cessation intervention. 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 was 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Counseling

Other

Smoking cessation counseling

Other names: Smoking cessation counseling

Contingency Management

Behavioral

Use of tangible rewards for abstinence from smoking

Other names: Low-cost contingency management

Nicotine patches

Drug

Nicotine patches

Other names: Nicotine replacement

Primary outcomes

  1. Abstinence Rate

    Time frame: 52 weeks

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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 29, 2009
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.