Developing a Smoking Cessation Intervention for Methadone Maintained Smokers
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation, Psychiatric, Gastrointestinal, Tobacco Consumers |
| Therapuetic Areas: | Gastroenterology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/8/2018 |
| Start Date: | October 2011 |
| End Date: | May 2014 |
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. .
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:
- 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.
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.
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
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