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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA023995 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contingency Management (CM) | Experimental | 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. |
|
| Noncontingent Reinforcement (NR) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Replacement Treatment (NRT) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1-month follow-up |
| 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. | 3-month follow up |
| 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. | 6-month follow up |
| 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. | 12-month follow up |
| Average Number of Cigarettes Per Day | 1-month follow up | |
| Average Number of Cigarettes Per Day | 3-month follow up | |
| Average Number of Cigarettes Per Day | Timeline Followback interview assessing number of cigarettes on each day of each 3-month reporting period | 6-month follow up |
| Average Number of Cigarettes Per Day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Damaris Rohsenow, Ph.D. | Brown University | Principal Investigator |
| Rosemarie Martin, Ph.D. | Brown University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University, Center for Alcohol and Addiction Studies | Providence | Rhode Island | 02903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12500132 | Background | Rohsenow DJ, Monti PM, Colby SM, Martin RA. Brief interventions for smoking cessation in alcoholic smokers. Alcohol Clin Exp Res. 2002 Dec;26(12):1950-1. doi: 10.1097/01.ALC.0000041006.59547.9A. No abstract available. | |
| 27658756 | Background | Rohsenow DJ, Martin RA, Tidey JW, Colby SM, Monti PM. Treating Smokers in Substance Treatment With Contingent Vouchers, Nicotine Replacement and Brief Advice Adapted for Sobriety Settings. J Subst Abuse Treat. 2017 Jan;72:72-79. doi: 10.1016/j.jsat.2016.08.012. Epub 2016 Aug 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | "Intent to Treat" Note: People who were lost were counted as smoked. | Posted | Number | participants | 1-month follow-up |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vivid Dreams/Nightmares | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Damaris Rohsenow, Ph.D. | Brown University | 401-863-6648 | damaris_rohsenow@brown.edu |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| D003419 | Crisis Intervention |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| Brief Advice | Behavioral | 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. |
|
|
| Contingency Management | Behavioral | 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. |
|
| Non-Contingent Reinforcement | Behavioral | 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. |
|
| 12-month follow up |
| Number of Participants With Relapse to Any Heavy Drinking | Heavy drinking = 6 or more drinks for men; 5 or more drinks for women | 1-month follow up |
| Number of Participants With Relapse to Any Heavy Drinking | Heavy drinking = 6 or more drinks for men; 5 or more drinks for women | 3-month follow up |
| Number of Participants With Relapse to Any Heavy Drinking | Heavy drinking = 6 or more drinks for men; 5 or more drinks for women | 6-month follow up |
| Number of Participants With Relapse to Any Heavy Drinking | Heavy drinking = 6 or more drinks for men; 5 or more drinks for women | 12-month follow up |
| Number of Participants With Relapse to Any Drug Use | 1-month follow up |
| Number of Participants With Relapse to Any Drug Use | 3-month follow up |
| Number of Participants With Relapse to Any Drug Use | 6-month follow up |
| Number of Participants With Relapse to Any Drug Use | 12-month follow up |
| Percent Smoking Days | 1-month follow up |
| Percent Smoking Days | 3-month follow up |
| Percent Smoking Days | 6-month follow up |
| Percent Smoking Days | 12-month follow up |
| 26498173 | Result | Mackillop J, Murphy CM, Martin RA, Stojek M, Tidey JW, Colby SM, Rohsenow DJ. Predictive Validity of a Cigarette Purchase Task in a Randomized Controlled Trial of Contingent Vouchers for Smoking in Individuals With Substance Use Disorders. Nicotine Tob Res. 2016 May;18(5):531-7. doi: 10.1093/ntr/ntv233. Epub 2015 Oct 24. |
| Lost to Follow-up |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
|
| 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. | "Intent to Treat" Note: People who were lost were counted as smoked. 3 participants died before 3 month follow up were coded as missing. | Posted | Number | participants | 3-month follow up |
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|
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| 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. | "Intent to Treat" Note: People who were lost were counted as smoked. 5 participants died before 6 month follow up were coded as missing. | Posted | Number | participants | 6-month follow up |
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| 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. | "Intent to Treat" Note: People who were lost were counted as smoked. 11 participants died before 12 month follow up were coded as missing. | Posted | Number | participants | 12-month follow up |
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| Primary | Average Number of Cigarettes Per Day | Posted | Mean | Standard Deviation | cigarettes | 1-month follow up |
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| Primary | Average Number of Cigarettes Per Day | 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. | Posted | Mean | Standard Deviation | cigarettes | 3-month follow up |
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| Primary | Average Number of Cigarettes Per Day | Timeline Followback interview assessing number of cigarettes on each day of each 3-month reporting period | 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. | Posted | Mean | Standard Deviation | cigarettes | 6-month follow up |
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| Primary | Average Number of Cigarettes Per Day | 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. | Posted | Mean | Standard Deviation | cigarettes | 12-month follow up |
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| Primary | Number of Participants With Relapse to Any Heavy Drinking | Heavy drinking = 6 or more drinks for men; 5 or more drinks for women | Posted | Number | participants | 1-month follow up |
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| Primary | Number of Participants With Relapse to Any Heavy Drinking | Heavy drinking = 6 or more drinks for men; 5 or more drinks for women | 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. | Posted | Number | participants | 3-month follow up |
|
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| Primary | Number of Participants With Relapse to Any Heavy Drinking | Heavy drinking = 6 or more drinks for men; 5 or more drinks for women | 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. | Posted | Number | participants | 6-month follow up |
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| Primary | Number of Participants With Relapse to Any Heavy Drinking | Heavy drinking = 6 or more drinks for men; 5 or more drinks for women | 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. | Posted | Number | participants | 12-month follow up |
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| Primary | Number of Participants With Relapse to Any Drug Use | Posted | Number | participants | 1-month follow up |
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| Primary | Number of Participants With Relapse to Any Drug Use | 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. | Posted | Number | participants | 3-month follow up |
|
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| Primary | Number of Participants With Relapse to Any Drug Use | 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. | Posted | Number | participants | 6-month follow up |
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| Primary | Number of Participants With Relapse to Any Drug Use | 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. | Posted | Number | participants | 12-month follow up |
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| Primary | Percent Smoking Days | Posted | Mean | Standard Deviation | percentage of days | 1-month follow up |
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| Primary | Percent Smoking Days | 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. | Posted | Mean | Standard Deviation | percentage of days | 3-month follow up |
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| Primary | Percent Smoking Days | 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. | Posted | Mean | Standard Deviation | percentage of days | 6-month follow up |
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| Primary | Percent Smoking Days | 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. | Posted | Mean | Standard Deviation | percentage of days | 12-month follow up |
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|
|
| 9 |
| 172 |
| 42 |
| 172 |
| 142 |
| 172 |
| EG001 | 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. | 2 | 168 | 34 | 168 | 143 | 168 |
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Psychiatric | Psychiatric disorders | Non-systematic Assessment |
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| Medical/Surgery | Surgical and medical procedures | Non-systematic Assessment |
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| Nervous System | Nervous system disorders | Non-systematic Assessment |
|
| Renal | Renal and urinary disorders | Non-systematic Assessment |
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| Social Circumstance | Social circumstances | Non-systematic Assessment |
|
| Vascular | Vascular disorders | Non-systematic Assessment |
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| Cardiac | Cardiac disorders | Non-systematic Assessment |
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| Multiple | General disorders | Non-systematic Assessment |
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| GI | Gastrointestinal disorders | Non-systematic Assessment |
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| Immune | Immune system disorders | Non-systematic Assessment |
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| Musculoskeletal | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Trouble Sleeping | Psychiatric disorders | Systematic Assessment |
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| Skin Irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Tense, Nervous, Anxious | Psychiatric disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
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| Dizziness | Ear and labyrinth disorders | Non-systematic Assessment |
|
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