Developing a Smoking Cessation Intervention for Methadone Maintained Smokers

Study Overview
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Brief Summary
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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. .

Detailed Description
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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: Be English speaking (i.e., able to participate in counseling sessions in English and to complete study interviews in English); Be enrolled in methadone treatment for at least three months; Be able to give informed consent; Be willing and able to participate in all study activities; Not have taken smoking cessation related medication or participated in smoking cessation counseling in the past six months; Have smoked at least 100 cigarettes during their lifetime and currently smoke every day or most days; Not currently be pregnant or breastfeeding or plan on getting pregnant or breastfeeding during the next six months; Have access to a working telephone; and, Be interested in participating in a smoking cessation intervention and quitting smoking within the next six months. 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.

Official Title
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Developing a Smoking Cessation Intervention for Methadone Maintained Smokers

Conditions
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Nicotine Dependence, Opiate Dependence

Intervention / Treatment
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* Behavioral: Intensive, tailored intervention
* Behavioral: NJ Quitline Referral


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled in methadone treatment for at least three months Able to give informed consent Willing and able to participate in all study activities Smoked at least 100 cigarettes during their lifetime Currently smoke every day or most days Has access to a working telephone Interested in participating in a smoking cessation intervention and quitting smoking within the next six months Exclusion Criteria: Unable to speak English fluently Took smoking cessation related medication or participated in smoking cessation counseling in the past three months Pregnant or breastfeeding or planning on becoming pregnant or breastfeeding during the next six months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive, tailored intervention<br>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. | Behavioral: Intensive, tailored intervention<br>* 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.<br>* Other names: IMB Model Based Smoking Cessation Intervention;|
| Active Comparator: Control Intervention<br>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. | Behavioral: NJ Quitline Referral<br>* Participants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit).<br>* Other names: General Population Smoking Cessation Intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking cessation, methadone treatment, nicotine addiction, drug treatment, drug addiction, tobacco dependence