Trial Outcomes & Findings for Contingency Management for Smoking in Substance Abusers (NCT NCT00807742)
NCT ID: NCT00807742
Last Updated: 2019-01-23
Results Overview
7 -day smoking cessation confirmed by expired alveolar CO levels of \< 10 ppm or salivary cotinine \< 16 ng/ml.
COMPLETED
NA
340 participants
1-month follow-up
2019-01-23
Participant Flow
Participant milestones
| Measure |
Contingency Management (CM)
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
Noncontingent Reinforcement (NR)
Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
|---|---|---|
|
Overall Study
STARTED
|
172
|
168
|
|
Overall Study
COMPLETED
|
126
|
114
|
|
Overall Study
NOT COMPLETED
|
46
|
54
|
Reasons for withdrawal
| Measure |
Contingency Management (CM)
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
Noncontingent Reinforcement (NR)
Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
|---|---|---|
|
Overall Study
Death
|
9
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
35
|
51
|
Baseline Characteristics
Contingency Management for Smoking in Substance Abusers
Baseline characteristics by cohort
| Measure |
Contingency Management (CM)
n=172 Participants
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
Noncontingent Reinforcement (NR)
n=168 Participants
Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
Total
n=340 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
172 Participants
n=93 Participants
|
168 Participants
n=4 Participants
|
340 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
37.87 years
STANDARD_DEVIATION 10.14 • n=93 Participants
|
37.28 years
STANDARD_DEVIATION 9.95 • n=4 Participants
|
37.58 years
STANDARD_DEVIATION 10.04 • n=27 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
111 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=93 Participants
|
116 Participants
n=4 Participants
|
229 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
172 participants
n=93 Participants
|
168 participants
n=4 Participants
|
340 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 1-month follow-upPopulation: "Intent to Treat" Note: People who were lost were counted as smoked.
7 -day smoking cessation confirmed by expired alveolar CO levels of \< 10 ppm or salivary cotinine \< 16 ng/ml.
Outcome measures
| Measure |
Contingency Management (CM)
n=172 Participants
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
Noncontingent Reinforcement (NR)
n=168 Participants
Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
|---|---|---|
|
Number of Participants Smoking Abstinent in Past 7 Days
|
16 participants
|
13 participants
|
PRIMARY outcome
Timeframe: 3-month follow upPopulation: "Intent to Treat" Note: People who were lost were counted as smoked. 3 participants died before 3 month follow up were coded as missing.
7 -day smoking cessation confirmed by expired alveolar CO levels of \< 10 ppm or salivary cotinine \< 16 ng/ml.
Outcome measures
| Measure |
Contingency Management (CM)
n=170 Participants
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
Noncontingent Reinforcement (NR)
n=167 Participants
Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
|---|---|---|
|
Number of Participants Smoking Abstinent in Past 7 Days
|
9 participants
|
5 participants
|
PRIMARY outcome
Timeframe: 6-month follow upPopulation: "Intent to Treat" Note: People who were lost were counted as smoked. 5 participants died before 6 month follow up were coded as missing.
7 -day smoking cessation confirmed by expired alveolar CO levels of \< 10 ppm or salivary cotinine \< 16 ng/ml.
Outcome measures
| Measure |
Contingency Management (CM)
n=168 Participants
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
Noncontingent Reinforcement (NR)
n=167 Participants
Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
|---|---|---|
|
Number of Participants Smoking Abstinent in Past 7 Days
|
6 participants
|
3 participants
|
PRIMARY outcome
Timeframe: 12-month follow upPopulation: "Intent to Treat" Note: People who were lost were counted as smoked. 11 participants died before 12 month follow up were coded as missing.
7 -day smoking cessation confirmed by expired alveolar CO levels of \< 10 ppm or salivary cotinine \< 16 ng/ml.
Outcome measures
| Measure |
Contingency Management (CM)
n=163 Participants
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
Noncontingent Reinforcement (NR)
n=166 Participants
Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
|---|---|---|
|
Number of Participants Smoking Abstinent in Past 7 Days
|
6 participants
|
3 participants
|
PRIMARY outcome
Timeframe: 1-month follow upOutcome measures
| Measure |
Contingency Management (CM)
n=172 Participants
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
Noncontingent Reinforcement (NR)
n=168 Participants
Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
|---|---|---|
|
Average Number of Cigarettes Per Day
|
5.28 cigarettes
Standard Deviation 5.49
|
7.98 cigarettes
Standard Deviation 5.49
|
PRIMARY outcome
Timeframe: 3-month follow upPopulation: Outcome data available for 291 participants who completed 3 month follow up. 3 participants died and 46 were lost to follow up before 3 month follow up.
Outcome measures
| Measure |
Contingency Management (CM)
n=148 Participants
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
Noncontingent Reinforcement (NR)
n=143 Participants
Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
|---|---|---|
|
Average Number of Cigarettes Per Day
|
8.84 cigarettes
Standard Deviation 7.57
|
9.89 cigarettes
Standard Deviation 6.19
|
PRIMARY outcome
Timeframe: 6-month follow upPopulation: Outcome data available for 268 participants who completed 6 month follow up. 5 participants died and 67 were lost to follow up before 6 month follow up.
Timeline Followback interview assessing number of cigarettes on each day of each 3-month reporting period
Outcome measures
| Measure |
Contingency Management (CM)
n=138 Participants
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
Noncontingent Reinforcement (NR)
n=130 Participants
Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
|---|---|---|
|
Average Number of Cigarettes Per Day
|
10.87 cigarettes
Standard Deviation 8.05
|
12.18 cigarettes
Standard Deviation 6.59
|
PRIMARY outcome
Timeframe: 12-month follow upPopulation: Outcome data available for 240 participants who completed 12 month follow up. 11 participants died and 89 were lost to follow up before 12 month follow up.
Outcome measures
| Measure |
Contingency Management (CM)
n=126 Participants
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
Noncontingent Reinforcement (NR)
n=114 Participants
Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
|---|---|---|
|
Average Number of Cigarettes Per Day
|
11.67 cigarettes
Standard Deviation 7.70
|
12.78 cigarettes
Standard Deviation 7.23
|
PRIMARY outcome
Timeframe: 1-month follow upHeavy drinking = 6 or more drinks for men; 5 or more drinks for women
Outcome measures
| Measure |
Contingency Management (CM)
n=172 Participants
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
Noncontingent Reinforcement (NR)
n=168 Participants
Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
|---|---|---|
|
Number of Participants With Relapse to Any Heavy Drinking
|
12 participants
|
8 participants
|
PRIMARY outcome
Timeframe: 3-month follow upPopulation: Outcome data available for 291 participants who completed 3 month follow up. 3 participants died and 46 were lost to follow up before 3 month follow up.
Heavy drinking = 6 or more drinks for men; 5 or more drinks for women
Outcome measures
| Measure |
Contingency Management (CM)
n=148 Participants
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
Noncontingent Reinforcement (NR)
n=143 Participants
Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
|---|---|---|
|
Number of Participants With Relapse to Any Heavy Drinking
|
23 participants
|
24 participants
|
PRIMARY outcome
Timeframe: 6-month follow upPopulation: Outcome data available for 268 participants who completed 3 month follow up. 5 participants died and 67 were lost to follow up before 3 month follow up.
Heavy drinking = 6 or more drinks for men; 5 or more drinks for women
Outcome measures
| Measure |
Contingency Management (CM)
n=138 Participants
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
Noncontingent Reinforcement (NR)
n=130 Participants
Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
|---|---|---|
|
Number of Participants With Relapse to Any Heavy Drinking
|
38 participants
|
35 participants
|
PRIMARY outcome
Timeframe: 12-month follow upPopulation: Outcome data available for 240 participants who completed 12 month follow up. 11 participants died and 89 were lost to follow up before 12 month follow up.
Heavy drinking = 6 or more drinks for men; 5 or more drinks for women
Outcome measures
| Measure |
Contingency Management (CM)
n=126 Participants
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
Noncontingent Reinforcement (NR)
n=114 Participants
Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
|---|---|---|
|
Number of Participants With Relapse to Any Heavy Drinking
|
38 participants
|
36 participants
|
PRIMARY outcome
Timeframe: 1-month follow upOutcome measures
| Measure |
Contingency Management (CM)
n=172 Participants
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
Noncontingent Reinforcement (NR)
n=168 Participants
Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
|---|---|---|
|
Number of Participants With Relapse to Any Drug Use
|
13 participants
|
16 participants
|
PRIMARY outcome
Timeframe: 3-month follow upPopulation: Outcome data available for 291 participants who completed 3 month follow up. 3 participants died and 46 were lost to follow up before 3 month follow up.
Outcome measures
| Measure |
Contingency Management (CM)
n=148 Participants
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
Noncontingent Reinforcement (NR)
n=143 Participants
Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
|---|---|---|
|
Number of Participants With Relapse to Any Drug Use
|
38 participants
|
32 participants
|
PRIMARY outcome
Timeframe: 6-month follow upPopulation: Outcome data available for 268 participants who completed 6 month follow up. 5 participants died and 67 were lost to follow up before 6 month follow up.
Outcome measures
| Measure |
Contingency Management (CM)
n=138 Participants
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
Noncontingent Reinforcement (NR)
n=130 Participants
Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
|---|---|---|
|
Number of Participants With Relapse to Any Drug Use
|
50 participants
|
42 participants
|
PRIMARY outcome
Timeframe: 12-month follow upPopulation: Outcome data available for 240 participants who completed 12 month follow up. 11 participants died and 89 were lost to follow up before 12 month follow up.
Outcome measures
| Measure |
Contingency Management (CM)
n=126 Participants
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
Noncontingent Reinforcement (NR)
n=114 Participants
Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
|---|---|---|
|
Number of Participants With Relapse to Any Drug Use
|
54 participants
|
50 participants
|
PRIMARY outcome
Timeframe: 1-month follow upOutcome measures
| Measure |
Contingency Management (CM)
n=172 Participants
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
Noncontingent Reinforcement (NR)
n=168 Participants
Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
|---|---|---|
|
Percent Smoking Days
|
77.51 percentage of days
Standard Deviation 33.02
|
88.33 percentage of days
Standard Deviation 25.48
|
PRIMARY outcome
Timeframe: 3-month follow upPopulation: Outcome data available for 291 participants who completed 3 month follow up. 3 participants died and 46 were lost to follow up before 3 month follow up.
Outcome measures
| Measure |
Contingency Management (CM)
n=148 Participants
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
Noncontingent Reinforcement (NR)
n=143 Participants
Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
|---|---|---|
|
Percent Smoking Days
|
82.39 percentage of days
Standard Deviation 30.63
|
88.40 percentage of days
Standard Deviation 25.48
|
PRIMARY outcome
Timeframe: 6-month follow upPopulation: Outcome data available for 268 participants who completed 6 month follow up. 5 participants died and 67 were lost to follow up before 6 month follow up.
Outcome measures
| Measure |
Contingency Management (CM)
n=138 Participants
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
Noncontingent Reinforcement (NR)
n=130 Participants
Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
|---|---|---|
|
Percent Smoking Days
|
88.49 percentage of days
Standard Deviation 26.45
|
92.30 percentage of days
Standard Deviation 21.91
|
PRIMARY outcome
Timeframe: 12-month follow upPopulation: Outcome data available for 240 participants who completed 12 month follow up. 11 participants died and 89 were lost to follow up before 12 month follow up.
Outcome measures
| Measure |
Contingency Management (CM)
n=126 Participants
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
Noncontingent Reinforcement (NR)
n=114 Participants
Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
|---|---|---|
|
Percent Smoking Days
|
87.38 percentage of days
Standard Deviation 26.62
|
91.53 percentage of days
Standard Deviation 22.86
|
Adverse Events
Contingency Management (CM)
Noncontingent Reinforcement (NR)
Serious adverse events
| Measure |
Contingency Management (CM)
n=172 participants at risk
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
Noncontingent Reinforcement (NR)
n=168 participants at risk
Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
2.9%
5/172 • Number of events 6
|
0.60%
1/168 • Number of events 1
|
|
Infections and infestations
Infection
|
3.5%
6/172 • Number of events 7
|
2.4%
4/168 • Number of events 4
|
|
Injury, poisoning and procedural complications
Injury
|
1.2%
2/172 • Number of events 2
|
4.2%
7/168 • Number of events 7
|
|
Psychiatric disorders
Psychiatric
|
13.4%
23/172 • Number of events 37
|
10.1%
17/168 • Number of events 29
|
|
Surgical and medical procedures
Medical/Surgery
|
0.58%
1/172 • Number of events 1
|
0.60%
1/168 • Number of events 1
|
|
Nervous system disorders
Nervous System
|
1.2%
2/172 • Number of events 2
|
0.60%
1/168 • Number of events 1
|
|
Renal and urinary disorders
Renal
|
0.58%
1/172 • Number of events 1
|
0.00%
0/168
|
|
Social circumstances
Social Circumstance
|
1.7%
3/172 • Number of events 3
|
0.00%
0/168
|
|
Vascular disorders
Vascular
|
0.58%
1/172 • Number of events 1
|
0.60%
1/168 • Number of events 1
|
|
Cardiac disorders
Cardiac
|
0.00%
0/172
|
0.60%
1/168 • Number of events 1
|
|
General disorders
Multiple
|
0.00%
0/172
|
0.60%
1/168 • Number of events 1
|
|
Gastrointestinal disorders
GI
|
0.00%
0/172
|
1.8%
3/168 • Number of events 3
|
|
Immune system disorders
Immune
|
0.00%
0/172
|
0.60%
1/168 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
0.00%
0/172
|
0.60%
1/168 • Number of events 1
|
Other adverse events
| Measure |
Contingency Management (CM)
n=172 participants at risk
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
Noncontingent Reinforcement (NR)
n=168 participants at risk
Controls for receiving payments, providing daily breath samples for CO level, and interaction between patient and research staff. NR allows them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level.
Nicotine Replacement Treatment (NRT): Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Brief Advice: Brief Advice (BA): Patients receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
|
|---|---|---|
|
Psychiatric disorders
Vivid Dreams/Nightmares
|
52.9%
91/172
|
50.6%
85/168
|
|
Psychiatric disorders
Trouble Sleeping
|
30.8%
53/172
|
34.5%
58/168
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
51.2%
88/172
|
51.2%
86/168
|
|
Psychiatric disorders
Tense, Nervous, Anxious
|
39.0%
67/172
|
40.5%
68/168
|
|
Gastrointestinal disorders
Nausea
|
31.4%
54/172
|
35.1%
59/168
|
|
Nervous system disorders
Headache
|
6.4%
11/172
|
10.7%
18/168
|
|
Ear and labyrinth disorders
Dizziness
|
5.8%
10/172
|
6.0%
10/168
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place