Trial Outcomes & Findings for Low-Cost Contingency Management for Smoking Cessation (NCT NCT01040260)

NCT ID: NCT01040260

Last Updated: 2018-06-06

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

103 participants

Primary outcome timeframe

52 weeks

Results posted on

2018-06-06

Participant Flow

Participant milestones

Participant milestones
Measure
Contingency Management
Use of tangible rewards for verified abstinence
Counseling Plus Nicotine Patches
Counseling plus nicotine patches, carbon monoxide (CO) testing without contingency management
Overall Study
STARTED
53
50
Overall Study
COMPLETED
38
39
Overall Study
NOT COMPLETED
15
11

Reasons for withdrawal

Reasons for withdrawal
Measure
Contingency Management
Use of tangible rewards for verified abstinence
Counseling Plus Nicotine Patches
Counseling plus nicotine patches, carbon monoxide (CO) testing without contingency management
Overall Study
Withdrawal by Subject
12
6
Overall Study
Lost to Follow-up
3
5

Baseline Characteristics

Low-Cost Contingency Management for Smoking Cessation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Contingency Management
n=53 Participants
Use of tangible rewards for verified abstinence
Counseling Plus Nicotine Patches
n=50 Participants
Counseling plus nicotine patches, CO testing without contingency management
Total
n=103 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
51 Participants
n=5 Participants
49 Participants
n=7 Participants
100 Participants
n=5 Participants
Age, Categorical
>=65 years
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
Age, Continuous
45.4 years
STANDARD_DEVIATION 13.5 • n=5 Participants
47.3 years
STANDARD_DEVIATION 12.0 • n=7 Participants
46.3 years
STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male
Female
12 Participants
n=5 Participants
11 Participants
n=7 Participants
23 Participants
n=5 Participants
Sex: Female, Male
Male
41 Participants
n=5 Participants
39 Participants
n=7 Participants
80 Participants
n=5 Participants
Region of Enrollment
United States
53 participants
n=5 Participants
50 participants
n=7 Participants
103 participants
n=5 Participants

PRIMARY outcome

Timeframe: 52 weeks

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

Outcome measures

Outcome measures
Measure
Contingency Management
n=53 Participants
Use of tangible rewards for verified abstinence
Counseling Plus Nicotine Patches
n=50 Participants
Counseling plus nicotine patches, CO testing without contingency management
Abstinence Rate
8 participants
10 participants

Adverse Events

Contingency Management

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Counseling Plus Nicotine Patches

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Contingency Management
n=53 participants at risk
Use of tangible rewards for verified abstinence
Counseling Plus Nicotine Patches
n=50 participants at risk
Counseling plus nicotine patches, CO testing without contingency management
Skin and subcutaneous tissue disorders
skin irritation
3.8%
2/53 • Number of events 2 • Participants are asked about adverse at each follow-up assessment visit.
4.0%
2/50 • Number of events 2 • Participants are asked about adverse at each follow-up assessment visit.

Additional Information

Dr. Timothy Carmody

University of California, San Francisco

Phone: (415) 221-4810

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place