Tobacco Use Cessation
Conditions
Keywords
tobacco use disorder
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.
Detailed description
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.
Interventions
OTHERCounseling
Smoking cessation counseling
BEHAVIORALContingency management
Use of tangible rewards for abstinence from smoking
DRUGNicotine patches
Nicotine patches
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abstinence Rate | 52 weeks | Number of participants who abstained from smoking during the 7 day period verified by CO testing |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Contingency Management Use of tangible rewards for verified abstinence | 53 |
| Counseling Plus Nicotine Patches Counseling plus nicotine patches, CO testing without contingency management | 50 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 5 |
| Overall Study | Withdrawal by Subject | 12 | 6 |
Baseline characteristics
| Characteristic | Counseling Plus Nicotine Patches | Contingency Management | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 51 Participants | 100 Participants |
| Age, Continuous | 47.3 years STANDARD_DEVIATION 12 | 45.4 years STANDARD_DEVIATION 13.5 | 46.3 years STANDARD_DEVIATION 12.8 |
| Region of Enrollment United States | 50 participants | 53 participants | 103 participants |
| Sex: Female, Male Female | 11 Participants | 12 Participants | 23 Participants |
| Sex: Female, Male Male | 39 Participants | 41 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 53 | 2 / 50 |
| serious Total, serious adverse events | 0 / 53 | 0 / 50 |
Outcome results
Primary
Abstinence Rate
Number of participants who abstained from smoking during the 7 day period verified by CO testing
Time frame: 52 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contingency Management | Abstinence Rate | 8 participants |
| Counseling Plus Nicotine Patches | Abstinence Rate | 10 participants |