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| ID | Type | Description | Link |
|---|---|---|---|
| K23DA025049 | 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 purpose of this study is to pilot and evaluate, in a randomized controlled trial, the immediate and long-term effects of a newly developed, tailored, intensive smoking cessation intervention among methadone maintained smokers and compared to a control condition (facilitated referral to the NJ Quitline). The newly developed intervention is evidence based, addresses the unique needs of methadone maintained smokers, is intensive, can be tailored to the individual, and builds on the strengths as well as addresses the gaps in previous treatments for methadone maintained smokers.
The investigators hypothesize that: (1) three months and six months after beginning treatment, those in the tailored intervention condition will be more likely to be abstinent from smoking than those in the control intervention condition (primary outcome); (2) there will be a greater relapse rate in the control intervention condition between the three and six month follow-up points than in the tailored intervention condition; (3) three and six months after beginning treatment, those in the tailored intervention condition will have better secondary smoking related outcomes (smoked fewer cigarettes per day in the past week, be more ready to quit, have greater self-efficacy for quitting, experience less nicotine dependence, and be more likely to have made a quit attempt) than those in the control intervention condition; (4) three and six months after beginning treatment, those in the tailored intervention condition will have better utilization of and adherence to smoking cessation pharmacotherapy, better mental and physical health, less perceived stress, greater social support, less drug and alcohol use, and greater involvement in drug and alcohol treatment than those in the control intervention condition; and (5) the newly created tailored intervention will be feasible and acceptable. .
Most individuals in methadone maintenance treatment are tobacco smokers. Also, people in methadone treatment are more likely to experience the health issues related to smoking than the general population. Yet, research has found that smokers receiving methadone treatment are interested in quitting and receiving tobacco cessation treatment, and people in drug treatment who quit smoking are less likely to use drugs.
To better help methadone maintained smokers quit smoking and prevent them from starting smoking again, we want to evaluate the effects of a new smoking cessation counseling intervention, designed for methadone maintained smokers as compared to a smoking cessation counseling intervention used with the general population.
Eligible participants will:
Participants will be randomly assigned to receive either a smoking cessation intervention tailored for methadone maintained smokers or a referral to a smoking cessation program available to the general population (NJ Quitline). Participants assigned to receive the tailored intervention, will participate in approximately eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the participant's methadone clinic. Treatment needs will be assessed during the first session and the intervention will be tailored to participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them.
Study staff will contact the NJ Quitline for participants assigned to the control condition, and a counselor from the Quitline will call them.
Regardless of treatment assignment, participants will be asked to provide a urine sample for a drug test and pregnancy test (for women) and complete an interview, using a computer or face-to-face, before beginning treatment or receiving the NJ Quitline referral and three months and six months after study enrollment.Each interview will take approximately 45 minutes to one hour to complete.
Participants will receive a $20 gift card for completing each research visit (i.e., computer or face-to-face interview), but will not be reimbursed for counseling visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive, tailored intervention | Experimental | Participants in the intensive intervention condition will receive eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the methadone clinic. Participant treatment needs will be assessed during the first session and the intervention will be tailored to the participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them. |
|
| Control Intervention | Active Comparator | Participants randomized to the control intervention will receive a referral to the NJ Quitline (a telephone smoking cessation counseling service). Participants will receive a brochure and information about the referral. Study staff will contact the NJ Quitline for control participants, and a counselor from the Quitline will call control participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive, tailored intervention | Behavioral | Eight, 45 minute counseling sessions, tailored to the individual and based on the Information-Motivation-Behavioral Skills model of behavior change. Incorporates motivational interviewing, education, cognitive-behavioral skills training. 12 week course of nicotine replacement patches provided. Nicotine lozenges also provided. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Seven-day Point Prevalence Smoking Abstinence | Self-reported not smoking "even a puff" within the previous seven days, and exhaled carbon monoxide reading of <8 parts per million. | during the previous seven days at three months post baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Median Number of Cigarettes Participants Smoked Per Day During the Past Week | Self-reported, median number of cigarettes per day during the previous seven days | during the previous seven days at three months post baseline |
| Number of Participants Who Experienced Any Quit Attempts Since Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nina Cooperman, Psy.D. | Rutgers Robert Wood Johnson Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intensive, Tailored Intervention | Participants in the intensive intervention condition will receive eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the methadone clinic. Participant treatment needs will be assessed during the first session and the intervention will be tailored to the participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them. Intensive, tailored intervention: Eight, 45 minute counseling sessions, tailored to the individual and based on the Information-Motivation-Behavioral Skills model of behavior change. Incorporates motivational interviewing, education, cognitive-behavioral skills training. 12 week course of nicotine replacement patches provided. Nicotine lozenges also provided. |
| FG001 | Control Intervention | Participants randomized to the control intervention will receive a referral to the NJ Quitline (a telephone smoking cessation counseling service). Participants will receive a brochure and information about the referral. Study staff will contact the NJ Quitline for control participants, and a counselor from the Quitline will call control participants. NJ Quitline Referral: Participants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intensive, tailored intervention: n=41 included in analyses (n=3 did not receive allocated intervention 1 dropped from methadone program before any sessions and two never came to sessions or research visits)
Control Intervention:
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| ID | Title | Description |
|---|---|---|
| BG000 | Intensive, Tailored Intervention | Participants in the intensive intervention condition will receive eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the methadone clinic. Participant treatment needs will be assessed during the first session and the intervention will be tailored to the participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them. Intensive, tailored intervention: Eight, 45 minute counseling sessions, tailored to the individual and based on the Information-Motivation-Behavioral Skills model of behavior change. Incorporates motivational interviewing, education, cognitive-behavioral skills training. 12 week course of nicotine replacement patches provided. Nicotine lozenges also provided. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Who Experienced Seven-day Point Prevalence Smoking Abstinence | Self-reported not smoking "even a puff" within the previous seven days, and exhaled carbon monoxide reading of <8 parts per million. | Three individuals randomized to the intensive, tailored intervention group did not attend any intervention sessions, and one participant in the control condition passed away; these individuals were not included in the analyses. | Posted | Count of Participants | Participants | during the previous seven days at three months post baseline |
|
2.5 years
AEs assessed at each counseling and research visit.
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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 | Intensive, Tailored Intervention | Participants in the intensive intervention condition will receive eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the methadone clinic. Participant treatment needs will be assessed during the first session and the intervention will be tailored to the participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them. Intensive, tailored intervention: Eight, 45 minute counseling sessions, tailored to the individual and based on the Information-Motivation-Behavioral Skills model of behavior change. Incorporates motivational interviewing, education, cognitive-behavioral skills training. 12 week course of nicotine replacement patches provided. Nicotine lozenges also provided. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Renal and urinary disorders | Systematic Assessment | Death related to pre-existing kidney disease. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cough up blood | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nina Cooperman | Rutgers Robert Wood Johnson Medical School | 732-235-8569 | cooperna@rwjms.rutgers.edu |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D009293 | Opioid-Related Disorders |
| D016540 | Smoking Cessation |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000079524 | Narcotic-Related Disorders |
| D015438 | Health Behavior |
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|
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| NJ Quitline Referral | Behavioral | Participants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit). |
|
|
Self-reported, smoke free for 24 hours or more since baseline (yes/no) |
| During the period between baseline and three months post enrollment |
| Number of Participants Who Experienced Seven-day Point Prevalence of Smoking Abstinence | Self-reported not smoking "even a puff" within the previous seven days, and exhaled carbon monoxide reading of <8 parts per million. | during the previous seven days at six months post baseline |
| Median Number of Cigarettes Smoked Per Day During the Past Week | Self-reported, median number of cigarettes per day during the previous seven days | during the previous seven days at six months post baseline |
| Number of Participants Who Experienced Any Quit Attempts Since Enrollment | Self-reported, smoke free for 24 hours or more since baseline (yes/no) | during the period between baseline and six months post-enrollment |
| BG001 | Control Intervention | Participants randomized to the control intervention will receive a referral to the NJ Quitline (a telephone smoking cessation counseling service). Participants will receive a brochure and information about the referral. Study staff will contact the NJ Quitline for control participants, and a counselor from the Quitline will call control participants. NJ Quitline Referral: Participants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Control Intervention | Participants randomized to the control intervention will receive a referral to the NJ Quitline (a telephone smoking cessation counseling service). Participants will receive a brochure and information about the referral. Study staff will contact the NJ Quitline for control participants, and a counselor from the Quitline will call control participants. NJ Quitline Referral: Participants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit). |
|
|
| Secondary | Median Number of Cigarettes Participants Smoked Per Day During the Past Week | Self-reported, median number of cigarettes per day during the previous seven days | Three individuals randomized to the intensive, tailored intervention group did not attend any intervention sessions, and one participant in the control condition passed away; these individuals were not included in the analyses. | Posted | Median | Inter-Quartile Range | cigarettes | during the previous seven days at three months post baseline |
|
|
|
| Secondary | Number of Participants Who Experienced Any Quit Attempts Since Baseline | Self-reported, smoke free for 24 hours or more since baseline (yes/no) | Three individuals randomized to the intensive, tailored intervention group did not attend any intervention sessions, and one participant in the control condition passed away; these individuals were not included in the analyses. | Posted | Count of Participants | Participants | During the period between baseline and three months post enrollment |
|
|
|
| Secondary | Number of Participants Who Experienced Seven-day Point Prevalence of Smoking Abstinence | Self-reported not smoking "even a puff" within the previous seven days, and exhaled carbon monoxide reading of <8 parts per million. | Three individuals randomized to the intensive, tailored intervention group did not attend any intervention sessions, and one participant in the control condition passed away; these individuals were not included in the analyses. | Posted | Count of Participants | Participants | during the previous seven days at six months post baseline |
|
|
|
| Secondary | Median Number of Cigarettes Smoked Per Day During the Past Week | Self-reported, median number of cigarettes per day during the previous seven days | Three individuals randomized to the intensive, tailored intervention group did not attend any intervention sessions, and one participant in the control condition passed away; these individuals were not included in the analyses. | Posted | Median | Inter-Quartile Range | cigarettes | during the previous seven days at six months post baseline |
|
|
|
| Secondary | Number of Participants Who Experienced Any Quit Attempts Since Enrollment | Self-reported, smoke free for 24 hours or more since baseline (yes/no) | Three individuals randomized to the intensive, tailored intervention group did not attend any intervention sessions, and one participant in the control condition passed away; these individuals were not included in the analyses. | Posted | Count of Participants | Participants | during the period between baseline and six months post-enrollment |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 20 |
| 44 |
| EG001 | Control Intervention | Participants randomized to the control intervention will receive a referral to the NJ Quitline (a telephone smoking cessation counseling service). Participants will receive a brochure and information about the referral. Study staff will contact the NJ Quitline for control participants, and a counselor from the Quitline will call control participants. NJ Quitline Referral: Participants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit). | 1 | 43 | 1 | 43 | 1 | 43 |
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| leg pain | General disorders | Systematic Assessment |
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| nausea | General disorders | Systematic Assessment |
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| insomnia | General disorders | Systematic Assessment |
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| depression | Psychiatric disorders | Systematic Assessment |
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| increased alcohol use | General disorders | Systematic Assessment |
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| itching/irritation at patch site | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| jittery/agitated/irritable | General disorders | Systematic Assessment |
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| tooth infection | Infections and infestations | Systematic Assessment |
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| headache | General disorders | Systematic Assessment |
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| vivid dreams | General disorders | Systematic Assessment |
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| hemorrhoids | General disorders | Systematic Assessment |
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| chest discomfort/pain | General disorders | Systematic Assessment |
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| increased appetite | General disorders | Systematic Assessment |
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| back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Extremely high expired carbon monoxide level | General disorders | Systematic Assessment |
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| shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| sores on tongue | General disorders | Systematic Assessment |
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| suicidal ideation | Psychiatric disorders | Systematic Assessment |
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| pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| insomnia/restless sleep | General disorders | Systematic Assessment |
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| vertigo | General disorders | Systematic Assessment |
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| anxiety | Psychiatric disorders | Systematic Assessment |
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| appendicitis | General disorders | Systematic Assessment |
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| bronchitis | Infections and infestations | Systematic Assessment |
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| cough | General disorders | Systematic Assessment |
|
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| D001519 | Behavior |