Substance Abuse
Conditions
Keywords
Contingency management for smoking for substance abusers, Contingency reinforcement for smoking abstinence, Contingency Management, Noncontingent Reinforcement
Brief summary
The aim of this study is to determine whether contingent reinforcement for smoking abstinence, compared to noncontingent reinforcement, increases the effectiveness of brief counseling and nicotine replacement on smoking abstinence of substance abusers in residential treatment.
Detailed description
Substance abusers have a high prevalence and rate of smoking with little success in quitting, so stronger approaches are needed to encourage attempts to quit smoking. The aim of this study is to determine whether contingent reinforcement for smoking abstinence (CM), compared to noncontingent reinforcement (NR), increases the effectiveness of brief counseling and nicotine replacement on smoking abstinence of substance abusers in residential treatment. The proposed study will be a 2-group design in which up to 274 substance abusers who smoke 10 or more cigarettes per day receive brief advice (4 sessions) and nicotine replacement (NRT) (8 weeks), and are randomized to 19 days of CM for smoking vs. a matched NR condition. The brief advice is adapted slightly for sobriety settings. Point-prevalence abstinence will be assessed at 1, 3, 6 and 12 months after starting treatment. Secondary aims evaluate effects of CM on substance use outcomes and potential mediators of effects on outcome, including within-treatment abstinence, motivation level and tolerance for smoking discomfort. The significance is to add knowledge about the most effective ways to maximize smoking cessation among substance abusers, important given that no methods are known to work with this population.
Interventions
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.
BEHAVIORALBrief Advice
Brief Advice (BA): Patients will 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.
BEHAVIORALContingency Management
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.
BEHAVIORALNon-Contingent Reinforcement
Controls for effects of receiving payments, providing daily breath samples for CO level, and degree of interaction between patient and research staff. NR will allow 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 attained.
Sponsors
National Institute on Drug Abuse (NIDA)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of substance abuse or dependence by DSM-IV criteria * in residential treatment at one particular agency * currently smoking at least 10 cigarettes per day for the past 6 months
Exclusion criteria
* hallucinating or delusional or marked organic impairment (to the point of impairing ability to understand informed consent) according to medical records * current use of nicotine replacement therapy, Zyban, or any other smoking cessation treatment * medical exclusions for NRT: pregnant or nursing; treatment in the last 3 months for unstable angina, severe congestive heart failure, uncontrolled hypertension; lung cancer; supplemental oxygen; history of adverse reactions to NRT; allergies to adhesive; or any severe skin disease that requires treatment (e.g., psoriasis or eczema).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Smoking Abstinent in Past 7 Days | 1-month follow-up | 7 -day smoking cessation confirmed by expired alveolar CO levels of \< 10 ppm or salivary cotinine \< 16 ng/ml. |
| Average Number of Cigarettes Per Day | 1-month follow up | — |
| Number of Participants With Relapse to Any Heavy Drinking | 1-month follow up | Heavy drinking = 6 or more drinks for men; 5 or more drinks for women |
| Number of Participants With Relapse to Any Drug Use | 1-month follow up | — |
| Percent Smoking Days | 1-month follow up | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 172 |
| 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. | 168 |
| Total | 340 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 9 | 2 |
| Overall Study | Lost to Follow-up | 35 | 51 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Noncontingent Reinforcement (NR) | Contingency Management (CM) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 168 Participants | 172 Participants | 340 Participants |
| Age, Continuous | 37.28 years STANDARD_DEVIATION 9.95 | 37.87 years STANDARD_DEVIATION 10.14 | 37.58 years STANDARD_DEVIATION 10.04 |
| Region of Enrollment United States | 168 participants | 172 participants | 340 participants |
| Sex: Female, Male Female | 52 Participants | 59 Participants | 111 Participants |
| Sex: Female, Male Male | 116 Participants | 113 Participants | 229 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 9 / 172 | 2 / 168 |
| other Total, other adverse events | 142 / 172 | 143 / 168 |
| serious Total, serious adverse events | 42 / 172 | 34 / 168 |
Outcome results
Primary
Average Number of Cigarettes Per Day
Time frame: 1-month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contingency Management (CM) | Average Number of Cigarettes Per Day | 5.28 cigarettes | Standard Deviation 5.49 |
| Noncontingent Reinforcement (NR) | Average Number of Cigarettes Per Day | 7.98 cigarettes | Standard Deviation 5.49 |
p-value: <0.00195% CI: [-0.71, -0.27]t-test, 2 sided
Primary
Average Number of Cigarettes Per Day
Time frame: 12-month follow up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contingency Management (CM) | Average Number of Cigarettes Per Day | 11.67 cigarettes | Standard Deviation 7.7 |
| Noncontingent Reinforcement (NR) | Average Number of Cigarettes Per Day | 12.78 cigarettes | Standard Deviation 7.23 |
p-value: 0.24995% CI: [-0.4, 0.11]t-test, 2 sided
Primary
Average Number of Cigarettes Per Day
Timeline Followback interview assessing number of cigarettes on each day of each 3-month reporting period
Time frame: 6-month follow up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contingency Management (CM) | Average Number of Cigarettes Per Day | 10.87 cigarettes | Standard Deviation 8.05 |
| Noncontingent Reinforcement (NR) | Average Number of Cigarettes Per Day | 12.18 cigarettes | Standard Deviation 6.59 |
p-value: 0.14895% CI: [-0.57, 0.33]t-test, 2 sided
Primary
Average Number of Cigarettes Per Day
Time frame: 3-month follow up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contingency Management (CM) | Average Number of Cigarettes Per Day | 8.84 cigarettes | Standard Deviation 7.57 |
| Noncontingent Reinforcement (NR) | Average Number of Cigarettes Per Day | 9.89 cigarettes | Standard Deviation 6.19 |
p-value: 0.19995% CI: [-0.38, 0.08]t-test, 2 sided
Primary
Number of Participants Smoking Abstinent in Past 7 Days
7 -day smoking cessation confirmed by expired alveolar CO levels of \< 10 ppm or salivary cotinine \< 16 ng/ml.
Time frame: 3-month follow up
Population: Intent to Treat Note: People who were lost were counted as smoked. 3 participants died before 3 month follow up were coded as missing.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contingency Management (CM) | Number of Participants Smoking Abstinent in Past 7 Days | 9 participants |
| Noncontingent Reinforcement (NR) | Number of Participants Smoking Abstinent in Past 7 Days | 5 participants |
p-value: 0.2995% CI: [0.57, 2.63]Chi-squared
Primary
Number of Participants Smoking Abstinent in Past 7 Days
7 -day smoking cessation confirmed by expired alveolar CO levels of \< 10 ppm or salivary cotinine \< 16 ng/ml.
Time frame: 1-month follow-up
Population: Intent to Treat Note: People who were lost were counted as smoked.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contingency Management (CM) | Number of Participants Smoking Abstinent in Past 7 Days | 16 participants |
| Noncontingent Reinforcement (NR) | Number of Participants Smoking Abstinent in Past 7 Days | 13 participants |
p-value: 0.60695% CI: [0.57, 2.63]Chi-squared
Primary
Number of Participants Smoking Abstinent in Past 7 Days
7 -day smoking cessation confirmed by expired alveolar CO levels of \< 10 ppm or salivary cotinine \< 16 ng/ml.
Time frame: 6-month follow up
Population: Intent to Treat Note: People who were lost were counted as smoked. 5 participants died before 6 month follow up were coded as missing.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contingency Management (CM) | Number of Participants Smoking Abstinent in Past 7 Days | 6 participants |
| Noncontingent Reinforcement (NR) | Number of Participants Smoking Abstinent in Past 7 Days | 3 participants |
p-value: 0.3295% CI: [0.49, 8.23]Chi-squared
Primary
Number of Participants Smoking Abstinent in Past 7 Days
7 -day smoking cessation confirmed by expired alveolar CO levels of \< 10 ppm or salivary cotinine \< 16 ng/ml.
Time frame: 12-month follow up
Population: Intent to Treat Note: People who were lost were counted as smoked. 11 participants died before 12 month follow up were coded as missing.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contingency Management (CM) | Number of Participants Smoking Abstinent in Past 7 Days | 6 participants |
| Noncontingent Reinforcement (NR) | Number of Participants Smoking Abstinent in Past 7 Days | 3 participants |
p-value: 0.29895% CI: [0.51, 8.45]Chi-squared
Primary
Number of Participants With Relapse to Any Drug Use
Time frame: 12-month follow up
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contingency Management (CM) | Number of Participants With Relapse to Any Drug Use | 54 participants |
| Noncontingent Reinforcement (NR) | Number of Participants With Relapse to Any Drug Use | 50 participants |
p-value: 0.87695% CI: [0.58, 1.6]Chi-squared
Primary
Number of Participants With Relapse to Any Drug Use
Time frame: 3-month follow up
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contingency Management (CM) | Number of Participants With Relapse to Any Drug Use | 38 participants |
| Noncontingent Reinforcement (NR) | Number of Participants With Relapse to Any Drug Use | 32 participants |
p-value: 0.51195% CI: [0.67, 2.06]Chi-squared
Primary
Number of Participants With Relapse to Any Drug Use
Time frame: 1-month follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contingency Management (CM) | Number of Participants With Relapse to Any Drug Use | 13 participants |
| Noncontingent Reinforcement (NR) | Number of Participants With Relapse to Any Drug Use | 16 participants |
p-value: 0.4995% CI: [0.36, 1.65]Chi-squared
Primary
Number of Participants With Relapse to Any Drug Use
Time frame: 6-month follow up
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contingency Management (CM) | Number of Participants With Relapse to Any Drug Use | 50 participants |
| Noncontingent Reinforcement (NR) | Number of Participants With Relapse to Any Drug Use | 42 participants |
p-value: 0.49995% CI: [0.72, 1.97]Chi-squared
Primary
Number of Participants With Relapse to Any Heavy Drinking
Heavy drinking = 6 or more drinks for men; 5 or more drinks for women
Time frame: 12-month follow up
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contingency Management (CM) | Number of Participants With Relapse to Any Heavy Drinking | 38 participants |
| Noncontingent Reinforcement (NR) | Number of Participants With Relapse to Any Heavy Drinking | 36 participants |
p-value: 0.81295% CI: [0.54, 1.62]Chi-squared
Primary
Number of Participants With Relapse to Any Heavy Drinking
Heavy drinking = 6 or more drinks for men; 5 or more drinks for women
Time frame: 1-month follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contingency Management (CM) | Number of Participants With Relapse to Any Heavy Drinking | 12 participants |
| Noncontingent Reinforcement (NR) | Number of Participants With Relapse to Any Heavy Drinking | 8 participants |
p-value: 0.40295% CI: [0.59, 3.72]Chi-squared
Primary
Number of Participants With Relapse to Any Heavy Drinking
Heavy drinking = 6 or more drinks for men; 5 or more drinks for women
Time frame: 3-month follow up
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contingency Management (CM) | Number of Participants With Relapse to Any Heavy Drinking | 23 participants |
| Noncontingent Reinforcement (NR) | Number of Participants With Relapse to Any Heavy Drinking | 24 participants |
p-value: 0.77295% CI: [0.49, 1.7]Chi-squared
Primary
Number of Participants With Relapse to Any Heavy Drinking
Heavy drinking = 6 or more drinks for men; 5 or more drinks for women
Time frame: 6-month follow up
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contingency Management (CM) | Number of Participants With Relapse to Any Heavy Drinking | 38 participants |
| Noncontingent Reinforcement (NR) | Number of Participants With Relapse to Any Heavy Drinking | 35 participants |
p-value: 0.9195% CI: [0.6, 1.77]Chi-squared
Primary
Percent Smoking Days
Time frame: 3-month follow up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contingency Management (CM) | Percent Smoking Days | 82.39 percentage of days | Standard Deviation 30.63 |
| Noncontingent Reinforcement (NR) | Percent Smoking Days | 88.40 percentage of days | Standard Deviation 25.48 |
p-value: 0.06995% CI: [-0.46, 0.02]t-test, 2 sided
Primary
Percent Smoking Days
Time frame: 1-month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contingency Management (CM) | Percent Smoking Days | 77.51 percentage of days | Standard Deviation 33.02 |
| Noncontingent Reinforcement (NR) | Percent Smoking Days | 88.33 percentage of days | Standard Deviation 25.48 |
p-value: 0.00195% CI: [-0.59, -0.15]t-test, 2 sided
Primary
Percent Smoking Days
Time frame: 6-month follow up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contingency Management (CM) | Percent Smoking Days | 88.49 percentage of days | Standard Deviation 26.45 |
| Noncontingent Reinforcement (NR) | Percent Smoking Days | 92.30 percentage of days | Standard Deviation 21.91 |
p-value: 0.20295% CI: [-0.4, 0.08]t-test, 2 sided
Primary
Percent Smoking Days
Time frame: 12-month follow up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contingency Management (CM) | Percent Smoking Days | 87.38 percentage of days | Standard Deviation 26.62 |
| Noncontingent Reinforcement (NR) | Percent Smoking Days | 91.53 percentage of days | Standard Deviation 22.86 |
p-value: 0.19995% CI: [-0.42, 0.09]t-test, 2 sided